The Pediatric Intermed: A New Clinical Decision Making Tool

• Sponsor: Children's Hospital of Eastern Ontario (Other)
• Overall Status: Completed
• CT.gov ID: NCT01781481
• Collaborator: Janssen Inc. (Industry)
• Enrollment: 148
• Location: 1
• Duration (Months): 52
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

The investigators have recently developed a paediatric adaptation of the INTERMED tool to address the unique developmental and social contexts of children and youth. The Pediatric INTERMED adopts a life-chart methodology to structure and organize complex case material in time, colour-coding domains to facilitate identification of areas of high need and risk for each patient. The focus of the present study is to examine the characteristics and usefulness of the tool in identifying psychosocial stress in children/youth diagnosed with Inflammatory Bowel Disease (IBD), as well as identifying overall case complexity. Children and parents will participate in a semi-structured structured interview with a clinical nurse who will then rate the 34-PIM items. To examine the construct validity of each of the Pediatric INTERMED domains (biological, psychological, social, caregiver/family, health care system) participants will complete questionnaires assessing social and psychological functioning, parent and family stress, quality of life and adaptive functioning. Information about disease status, and health care utilization will be obtained from medical chart review. It is hypothesized that greater case complexity will be predictive of more complex disease course/treatment, poorer quality of life, and increased health care utilization.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease

Detailed Description

Inflammatory Bowel Disease (Crohn's disease/ulcerative colitis) manifests itself in children and adolescents in up to 1/3 of those that will eventually develop these conditions. It is fast becoming an increasing problem with a 50% increase in Crohn's disease diagnosed in young children in the last decade. The patient's chronic symptoms can be both due to and result in increased child and family psychosocial stress. Similarly, treatments may add to psychosocial stress. Failure to address these psychosocial issues can lead to greater risk for poor treatment adherence, higher utilization of health care, and increased psychiatric co-morbidity. As such, improvement in health care providers' capacity to identify factors contributing to case complexity offers significant potential for improving outcomes.

Assessment of biological, psychological, social and health delivery of children's chronic illness has not been consistently integrated into the health care system. Physical and mental health services are often disconnected. Identifying those who would benefit from a mental health referral typically rests on the primary care physician or specialist and is often triggered by crises. There is also variability in physician education and comfort level in assessing psychosocial issues and especially in children with chronic illnesses in which symptoms of physical disease and mental health can overlap. Oftentimes this leaves the most responsible physician wanting for a simple assessment tool to try and determine who might be at risk and benefit from mental health intervention.

The adult INTERMED is a clinical decision-support tool that provides indicators of biological, psychological, social, heath care needs, as well as an overall index of case complexity. The tool is efficient to administer and has been successfully used by varied health care professionals in diverse medical settings to detect psychosocial needs, facilitate referral to effective services and improve health practices and outcomes. However, there is no comparable validated tool for use with children/youth.

The investigators have recently developed a pediatric adaptation of the adult INTERMED to address the unique developmental and social contexts of children and youth. A Delphi group of international experts in the field of pediatric chronic illness has reviewed the instrument to ensure clinical relevance, utility and communication clarity. Initial pilot data has demonstrated the Pediatric INTERMED has very good item inter-rater reliability. The focus of the current study is to examine the usefulness of this tool to identify biopsychosocial needs in IBD children/youth. Canada has a very high IBD incidence and prevalence. Given the facts that children with IBD face an unpredictable disease course, complex symptoms and difficult management regimens that can significantly impact their lives, it is not surprising that patients with this chronic incurable condition are highly vulnerable to mental health comorbidities. The development of this new tool will have significant importance if it proves to be useful in this population. The current study will examine a sizeable cohort of patients with regards to the relations between Pediatric INTERMED domains and other measures of children's disease, mood, behaviour, quality of life, family stress and strengths, and health services utilization. Both ulcerative colitis and Crohn's disease in children and youth lend themselves very well to this study because of the validated measures of disease severity that have been developed already.

Implementation of the novel Pediatric INTERMED n clinical practice will provide a new way to assist IBD Teams in screening their patients to be proactive in referral to mental health resources, and facilitate case management which targets patient needs. Clearly, clinicians are well aware that compliance, anxiety and depression will affect disease outcomes and too often these are only dealt with at times of crisis that has led to disease flare or reports that medicines are no longer effective. Use of this structured assessment tool begins to realize the potential of developing a truly integrated biopsychosocial approach to this chronic disease. The ease of use and objective nature of the tool will enhance communication among primary and tertiary providers and contribute to best practice approaches in the provision of integrated physical and mental health care. It will also assist in monitoring the impact of childhood chronic illness, identify factors linked to optimal health outcomes and inform program planning and resource allocations.

Study Design

Children/youth (ages of 8-17) followed in the IBD Clinic at the Children's Hospital of Eastern Ontario (CHEO) with confirmed diagnoses of IBD (Crohn's disease or ulcerative colitis) are eligible for the study. A clinical nurse will complete the Pediatric INTERMED for all study participants: based on information obtained from a review of the patients' hospital chart and a semi-structured interview conducted with the child/youth and primary caregivers), Following the Pediatric INTERMED interview, children/youth and parents participating in the project will complete a battery of self-report instruments to provide assessments of patients' social and psychological functioning, parent/family stresses, adjustment and resources. In addition, information will be obtained from the patients' charts about aspects of their diagnoses, treatment regimens, disease activity and complications, and health care utilization in the 3 months prior to their participation in the study.

Primary Hypotheses/Objectives and Statistical Rationale

1. Demonstrate that the Pediatric INTERMED is a reliable tool for use in IBD children (good inter-rater reliability and internal consistency). 40 interviews with the clinical research nurse will be videotaped so that a second health care professional trained in the use of the PIM, can also complete the PIM tool, in order to examine inter-rater reliability. Agreement between raters will be measured by means of intraclass correlations. Items within each domain will be examined to confirm that they meet internal consistency criteria (Cronbach's Alpha of .80).

2. Demonstrate that the Pediatric INTERMED domains successfully identify patient needs. Concurrent validity of the Pediatric INTERMED will be examined by looking at the Spearman rank, Pearson correlations, as appropriate, between each domain score and the measures hypothesized to be conceptually linked to the domain. To assess aspects of the Psychological Domain, the patients will complete the Children's Depression Inventory, the Multidimensional Anxiety Scale for Children and parents will complete the Child Behaviour Checklist (CBCL). Measures linked to the Social Domain of the PIM, include The Functional Disability Inventory, which taps the child's involvement in daily activities, and CBCL Competence Scores (Social, School, Activities), and the IMPACT-III, an IBD specific quality of life measure. To examine constructs linked to the Caregiver/Family Domain parents will complete the Pediatric Inventory for Parents, an index of childhood illness-related parenting stress, the Family Inventory of Life Events and Changes and the Family Inventory of Resources for Management. Disease/treatment and health care data gathered will be used to validate the Biological and Health System Domains.

3. Demonstrate that Pediatric INTERMED Complexity score is predictive of increased health care utilization. A general linear approach will be used to study the relation of the Pediatric INTERMED to health service utilization. Multivariate models will also be tested including potential covariates such as disease severity, time since diagnosis.

Statistical Power Calculations

The CHEO GI clinic sees 40 to 60 new patients diagnosed with IBD per year. In 2007 the clinic actively followed 265 children with IBD. Once diagnosed children are followed on an ongoing basis. The frequency of follow-up appointments varies depending on the nature and course of a child's disease, but the children/youth are seen at minimum three times each year. In general, participation rates in studies of children/youth with chronic illness are typically in the vicinity of 80-90% or better and this figure is consistent with the experience of the CHEO IBD clinic in the recruitment of patients into various knowledge generation studies. The PIM involves 5 domains of information inclusive of various components. To achieve significance with the various domains the investigators estimated that a total of 140-150 children will need to be enrolled. This sample size is sufficient to ensure that there are a sufficient number of observations per variable to conduct multivariate analyses. Tabachnick and Fidell (2007) and others indicated that 4 is the absolute minimum number of observations per variable to conduct multivariate analyses. A subject size of 140-150 would be sufficient to provide 4 observations per variable. Further, the anticipated sample size is sufficient to conduct all proposed analyses. Further corrections for multiple testing will be applied on a per-analysis basis.

Study Design

• Study Type: Observational
• Actual Enrollment: 148 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: The Pediatric Intermed: A New Clinical Decision Making Tool for Proactive Evaluation of Psychosocial Stress in Children With Inflammatory Bowel Disease
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Children and youth with IBD Children/youth (ages 8-17) with confirmed diagnoses of IBD.

Outcome Measures

Primary Outcome Measures

1. Pediatric INTERMED- Complexity Index [Time of Study Participation (Completion of Pediatric INTERMED tool)]

   34 item screening tool which identifies biological, psychological, social, caregiver/family and health service needs that contribute to case complexity. Each item is rated on a scale from 0-3 (0= no need to act; 1= watchful waiting or preventive intervention, 2=need for action, 3=need for immediate action). Minimum total score is 0 and Maximum score would be 102 (high complexity). Items on the Pediatric INTERMED are organized into 5 domains: Biological Domain (6 items). Minimum score is 0 and maximum score is 18 (high biological complexity). Psychological Domain (9 items). Minimum score is 0 and maximum score is 27 (high psychological complexity). Social Domain (7 items). Minimum score is 0 and maximum score is 21 (high social complexity). Family/Caregiver Domain (7 items). Minimum score is 0 and maximum score is 21 (high family/caregiver complexity). Health Services Domain (5 items). Minimum score is 0 and maximum score is 15 (high health service complexity).

2. Correlations Between Pediatric INTERMED Domain Scores [Pediatric INTERMED scores at time of study participation]

   Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED domain scores.

3. Pediatric INTERMED Items [Day 1 (At time of Pediatric Intermed Interview)]

   Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items.

4. IBD Disease Severity [Day 1 (Date of patient's participation in the Pediatric Intermed interview).]

   IBD Disease Severity Index categorizes patient's level of disease severity based on patient scores on the Pediatric Crohn's Disease Activity Index (PCDAI): (Hymans, Markowitz, Otley et al., 2005) and the Pediatric Ulcerative Colitis Activity Index (PUCAI) (Turner, Otley, Mack et al., 2007). Children's scores on either of these indices are used to categorize the severity of their disease as: inactive, mild, moderate, or severe.

5. Time Since IBD Diagnosis [Data collected through chart review at time of Pediatric INTERMED interview.]

   Time since subject's initial IBD diagnosis. Data for each subject was obtained from chart review and was coded in "months since date of diagnosis", with a range from 1 - 131 months.

6. Disease Course and Treatment [Data collected through chart review with respect to the period since diagnosis and Day 1 (date that patient's participation in Pediatric Intermed interview)]

   Number of hospitalizations since diagnosis (total number recorded in health record), number of surgeries since diagnosis (total number recorded in health record), number of courses of Prednisone (total number recorded in health record).

7. IBD Treatment With Immunomodulators or Anti-TNFa Medications [Information from review of participants chart from time of diagnosis until study participation (date of Pediatric INTERMED interview).]

   Use of Immunomodulators (azathioprine or methotrexate). Coded for each participant as "yes" (Score of 1) or "no" (Score of 2). Use of anti-Tumor Necrosis Factor alpha (TNFa) medications (infliximab or adalimumab). Coded for each participant as "yes" (Score of 1) or "no" (Score of 2).

8. Functional Disability Inventory [Day 1 (Date of patient's participation in the Pediatric Intermed interview).]

   Functional Disability Inventory: (FDI); Walker & Greene, 1991). The FDI assesses illness related activity limitations in children and adolescents. The measure consists of 15 items that are scored by the child and parent as (0) "no trouble" to "(4) "impossible". The minimum score is 0 and the maximum score is 60, with higher scores indicating greater functional disability. The FDI has demonstrated good psychometric properties with test-retest reliability of .92 and .85 at the 3-month follow-up. Concurrent validity was provided by correlation (r=.52, p<.001) between the FDI and an objective index of disability (Walker & Greene, 1991).

9. Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease. [Day 1 (At time of Pediatric Intermed Interview)]

   35-item self report measure for assessing quality of life in children with IBD (Otley, Griffiths, Hale et al., 2006). Items are rated on a 5-point Likert scale, with lower scores indicating poorer health related quality of life. Scores can range from 35-175. Four factor scores can be calculated: General Well-Being, Emotional Functioning, Social Functioning, Body Image, as well as a Total Quality of Life Score (Perrin, Kuhlthau, Chughtai et al., 2008).

10. Child Behaviour Checklist [Day 1 (Date of patient's participation in the Pediatric Intermed interview).]

    Child Behaviour Checklist: (CBCL: Achenbach 1991). The CBCL is used to evaluate behaviour problems and social competencies of children 6 to 18 years old. The measure is completed by parents or parent surrogates who base their ratings on the preceding 6 months. It is comprised of 120 problem items that factor into eight syndrome scales, which can be grouped into Internalizing, Externalizing and Total Problem Scales. Higher scores indicate greater level of emotional/behavioural difficulties. In the present study we utilized the following CBCL subscale scores: Internalizing, Externalizing, Social Competence, Activities Competence, Academic Competence. All scores reported are scaled to T Scores.

11. Children's Depression Inventory [Administered at study entry]

    27 item self-report questionnaire used to measure depressive symptoms in children and youth (Kovacs 1992). Each item is rated on a 3-point Likert scale (0-2) with a minimum score of 0 and a maximum score of 54, with higher scores indicating more depressive symptoms. Raw scores were scaled to T-scores to control for age and gender differences.

12. Multidimensional Anxiety Scale for Children [Day 1 (Date of patient's participation in the Pediatric Intermed interview).]

    Multidimensional Anxiety Scale for Children: (MASC; March et a., 1997). The MASC is a pediatric self-report scale that measures symptoms of anxiety. It consists of 39 items assessing physical symptoms of anxiety, harm avoidance, social anxiety and separation/panic. Each item is answered using a four point Likert scale ranging from (0) "never true about me" to (3) "often true about me". Total scores can range from 0 to 117. The raw total score was scaled to T-Scores to control for age and sex differences.

13. Pediatric Inventory for Parents- Difficulty Score [Day 1 (Date of patient's participation in the Pediatric Intermed interview).]

    Pediatric Inventory for parents: (PIP; Streisand et al., 2001). The PIP is a 42-item self-report measure of parenting stress associated with caring for a medically ill child. It is the only published measure of parenting stress the specifically taps the experiences and stresses that parents face when caring for a medically ill child. The Difficulty Score - indicates parents' perception of the perceived difficulty of each stressor/item. Each item is scored on a 5 point Likert scale, with total scores ranging from 42 to 210, with higher scores indicating greater "perceived difficulty".

14. Family Inventory of Life Events and Changes [Day 1 (Date of patient's participation in the Pediatric Intermed interview).]

    Family Inventory of Life Events and Changes (FILE): (McCubbin & Patterson, 1991). The FILE is a 71-item, yes/no instrument that assesses chronic and recent life stress in nine areas: intra-family strains, marital strains, pregnancy and childbearing strains, finance and business strains, work-family transitions and strains, illness and family care strains, losses, transition in and out, and family and legal violations. Family members indicate whether particular stressful events have occurred. The FILE has been found to have high reliability (Cronbach's alpha=.72), good test-retest reliability, internal consistency and evidence of construct validity. Scores can range from 0-71, with higher scores indicating greater family stress.

15. Family Inventory of Resources for Management [Day 1 (Date of patient's participation in the Pediatric Intermed interview).]

    Family Inventory of Resources for Management (FIRM): (McCubbin & Comeau 1991). The FIRM was developed to assess the family's repertoire of resources. The scale is comprised of 69 items, which are responded to using a 4-point Likert scale format (0-3). The scale has been found to have good internal reliability (r=.89, Cronbach's alpha), content and concurrent validity when used in normative sample of families with chronically ill children. The possible range for the total score is from 0-207, with higher scores indicating greater family resources for management. The Financial Well-Being subscale consists of 16 items, with potential scores ranging from 0-48, with higher scores indicating greater family financial resources.

16. Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning [Pediatric INTERMED and Functioning at study participation and Disease related indices since IBD Diagnosis]

    Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domains and items. Refer to Outcome Measure 4 for information pertaining to IBD Disease Severity. Refer to Outcome Measure 5 for information pertaining to Disease Treatments. Refer to Outcome Measure 8 for information pertaining to Functioning Disability Inventory. Refer to Outcome Measure 9 for information pertaining to the IMPACT III- Quality of Life Questionnaire.

17. Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning. [Day 1 (Time of Study Participation)]

    Relations between Pediatric INTERMED Psychological, Social and Family Domain scores and other validated measures of subjects' psychosocial adjustment, including depression (Children's Depression Inventory- Outcome Measure 11), anxiety (Multidimensional Anxiety Scale for Children-Outcome Measure 12), Behavioural Adjustment (Internalizing and Externalizing Scores on the CBCL- Outcome Measure 10), Competence (Social, Activities and School Competence Scores from the CBCL- Outcome Measure 10), and family functioning (Parenting Inventory for Parents- Outcome Measure 13, Family Inventory of Life Events-Outcome Measure 14, Family Inventory of Resources for Management- Outcome Measure 15), and IBD health-related quality of life (IMPACT III: Emotional Functioning and Social Interactions scales- Outcome Measure 9).

18. Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range. [Day 1 (At time of Pediatric Intermed Interview)]

    This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat item when they scored in the clinical range on the Multidimensional Anxiety Scale for Children. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 12 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Multidimensional Anxiety Scale for Children were categorized as falling into the clinical range.

19. Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range. [Day 1 (At time of Pediatric Intermed Interview)]

    This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Children's Depression Inventory. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 11 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Children's Depression Inventory were categorized as falling into the clinical range.

20. Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range. [Day 1 (At time of Pediatric Intermed Interview)]

    This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Internalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Internalizing Scale were categorized as falling into the clinical range.

21. Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range. [Day 1 (At time of Pediatric Intermed Interview)]

    This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Externalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Externalizing Scale were categorized as falling into the clinical range.

22. Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators [Pediatric INTERMED and FIRM scores obtained at Study Entry and Disease and Health Care Indicators since IBD Diagnosis]

    Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domain scores and items. Refer to Outcome Measure 6 for information pertaining to Disease/Treatment Indicators. Refer to Outcome Measure 23 for information about the Number of Services involved in Child's Care, and to Outcome Measure 15 for information about the Family Inventory of Resources for Management.

23. Total Number of Hospital Services Involved in Child's Care. [Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)]

    Measure of number of hospital services involved in each child's care during the three month period prior to the Pediatric INTERMED interview.

24. Number of Calls to IBD Nurse [Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)]

    Total number of calls made by patient or parent to the IBD clinic nurse during the 3-month period prior to the Pediatric Intermed Interview

25. Number of Extra Appointments With the IBD Team [Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)]

    Number of extra appointments (unscheduled, emergency) with the IBD Team during the 3 month period prior to the Pediatric INTERMED interview.

26. Number of Visits to the Hospital Emergency Department [Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)]

    Number of times that the patient visited the hospital Emergency Department in the 3-month period prior to the Pediatric INTERMED interview.

27. Number of Inpatient Hospital Admissions [Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)]

    Total number of times that the patient was admitted to hospital during the 3-month period prior to the Pediatric INTERMED Interview.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diagnosis of IBD (Crohn's or Ulcerative Colitis)

• fluency in English or French

• between the ages of 8 and 17

• residing in the CHEO catchment area.

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Eastern Ontario	Ottawa	Ontario	Canada	K1H 8L1

Sponsors and Collaborators

• Children's Hospital of Eastern Ontario
• Janssen Inc.

Investigators

• Principal Investigator: Janice S Cohen, Ph.D., Children's Hospital of Eastern Ontario

Study Documents (Full-Text)

None provided.

More Information

Publications

• Achenbach TM, Rescorla LA. Manual for ASEBA School-Age Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families. 2001.
• Astin JA, Soeken K, Sierpina VS, Clarridge BR. Barriers to the integration of psychosocial factors in medicine: results of a national survey of physicians. J Am Board Fam Med. 2006 Nov-Dec;19(6):557-65.
• Benchimol EI, Guttmann A, Griffiths AM, Rabeneck L, Mack DR, Brill H, Howard J, Guan J, To T. Increasing incidence of paediatric inflammatory bowel disease in Ontario, Canada: evidence from health administrative data. Gut. 2009 Nov;58(11):1490-7. doi: 10.1136/gut.2009.188383. Epub 2009 Aug 2.
• Bernstein CN, Wajda A, Svenson LW, MacKenzie A, Koehoorn M, Jackson M, Fedorak R, Israel D, Blanchard JF. The epidemiology of inflammatory bowel disease in Canada: a population-based study. Am J Gastroenterol. 2006 Jul;101(7):1559-68. Erratum in: Am J Gastroenterol. 2006 Aug;101(8):1945.
• Fischer CJ, Stiefel FC, De Jonge P, Guex P, Troendle A, Bulliard C, Huyse FJ, Gaillard R, Ruiz J. Case complexity and clinical outcome in diabetes mellitus. A prospective study using the INTERMED. Diabetes Metab. 2000 Sep;26(4):295-302.
• Han, C, Zhao N, Blank M, Gasink, C. Impact of psychiatric disorders on patients with crohn's disease: An analysis based on a healthcare claims database. Gastroenterology-Supplements 2010; 138(5), S-9.
• Hyams J, Markowitz J, Otley A, Rosh J, Mack D, Bousvaros A, Kugathasan S, Pfefferkorn M, Tolia V, Evans J, Treem W, Wyllie R, Rothbaum R, del Rosario J, Katz A, Mezoff A, Oliva-Hemker M, Lerer T, Griffiths A; Pediatric Inflammatory Bowel Disease Collaborative Research Group. Evaluation of the pediatric crohn disease activity index: a prospective multicenter experience. J Pediatr Gastroenterol Nutr. 2005 Oct;41(4):416-21.
• Kathol, R.G., Perez, R., Cohen, J.S., (2010). The Integrated Case Management Model: Assisting Complex Patients Regain Physical and Mental Health, Springer Publishing Co. N,Y,.
• Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8.
• Lyons, JS. Communimetrics. A communication theory of measurement for human services. New York: Springer, 2009.
• Mackner LM, Crandall WV, Szigethy EM. Psychosocial functioning in pediatric inflammatory bowel disease. Inflamm Bowel Dis. 2006 Mar;12(3):239-44. Review.
• March JS, Parker JD, Sullivan K, Stallings P, Conners CK. The Multidimensional Anxiety Scale for Children (MASC): factor structure, reliability, and validity. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):554-65.
• McCubbin H, Comeau J. Family Inventory of Resources for Management. In McCubbin H, Thompson A, eds. Family assessment inventories for research and practice, pp. 81-100. Madison: University of Wisconsin, 1991.
• McCubbin H, Patterson J. Family Inventory of Life Events and changes. In McCubbin H, Thompson A, eds. Family assessment inventories for research and practice, pp 81-100. Madison.: University of Wisconsin, 1991.
• Otley AR, Griffiths AM, Hale S, Kugathasan S, Pfefferkorn M, Mezoff A, Rosh J, Tolia V, Markowitz J, Mack D, Oliva-Hemker M, Wyllie R, Rothbaum R, Bousvaros A, Del Rosario JF, Evans J, Blanchard W, Hyams J; Pediatric IBD Collaborative Research Group. Health-related quality of life in the first year after a diagnosis of pediatric inflammatory bowel disease. Inflamm Bowel Dis. 2006 Aug;12(8):684-91.
• Stiefel F, Zdrojewski C, Bel Hadj F, Boffa D, Dorogi Y, So A, Ruiz J, de Jonge P. Effects of a multifaceted psychiatric intervention targeted for the complex medically ill: a randomized controlled trial. Psychother Psychosom. 2008;77(4):247-56. doi: 10.1159/000129658. Epub 2008 Apr 28.
• Stiefel FC, Huyse FJ, Söllner W, Slaets JP, Lyons JS, Latour CH, van der Wal N, de Jonge P. Operationalizing integrated care on a clinical level: the INTERMED project. Med Clin North Am. 2006 Jul;90(4):713-58. Review.
• Streisand R, Braniecki S, Tercyak KP, Kazak AE. Childhood illness-related parenting stress: the pediatric inventory for parents. J Pediatr Psychol. 2001 Apr-May;26(3):155-62.
• Szigethy E, Craig AE, Iobst EA, Grand RJ, Keljo D, DeMaso D, Noll R. Profile of depression in adolescents with inflammatory bowel disease: implications for treatment. Inflamm Bowel Dis. 2009 Jan;15(1):69-74. doi: 10.1002/ibd.20693.
• Turner D, Otley AR, Mack D, Hyams J, de Bruijne J, Uusoue K, Walters TD, Zachos M, Mamula P, Beaton DE, Steinhart AH, Griffiths AM. Development, validation, and evaluation of a pediatric ulcerative colitis activity index: a prospective multicenter study. Gastroenterology. 2007 Aug;133(2):423-32. Epub 2007 May 21.
• Walker LS, Greene JW. The functional disability inventory: measuring a neglected dimension of child health status. J Pediatr Psychol. 1991 Feb;16(1):39-58.

• Responsible Party: Janice S.Cohen, Psychologist, Children's Hospital of Eastern Ontario
• ClinicalTrials.gov Identifier: NCT01781481
• Other Study ID Numbers: 09/32E
• First Posted: Feb 1, 2013
• Last Update Posted: Jul 26, 2016
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Janice S.Cohen, Psychologist, Children's Hospital of Eastern Ontario: Psychosocial Stress and Adjustment; Pediatric Chronic Illness; Decision-support tool; Integrated Health Care; Case Complexity
• Additional relevant MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases

Study Results

Participant Flow

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of Inflammatory Bowel Disease (IBD).
Period Title: Overall Study
STARTED	148
COMPLETED	148
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Overall Participants	148
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	14.00
Sex: Female, Male (Count of Participants)
Female	59 39.9%
Male	89 60.1%
Region of Enrollment (participants) [Number]
Canada	148 100%

Outcome Measures

1. Primary Outcome

Title	Pediatric INTERMED- Complexity Index
Description	34 item screening tool which identifies biological, psychological, social, caregiver/family and health service needs that contribute to case complexity. Each item is rated on a scale from 0-3 (0= no need to act; 1= watchful waiting or preventive intervention, 2=need for action, 3=need for immediate action). Minimum total score is 0 and Maximum score would be 102 (high complexity). Items on the Pediatric INTERMED are organized into 5 domains: Biological Domain (6 items). Minimum score is 0 and maximum score is 18 (high biological complexity). Psychological Domain (9 items). Minimum score is 0 and maximum score is 27 (high psychological complexity). Social Domain (7 items). Minimum score is 0 and maximum score is 21 (high social complexity). Family/Caregiver Domain (7 items). Minimum score is 0 and maximum score is 21 (high family/caregiver complexity). Health Services Domain (5 items). Minimum score is 0 and maximum score is 15 (high health service complexity).
Time Frame	Time of Study Participation (Completion of Pediatric INTERMED tool)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Measure Participants	148
Total Complexity Index	24
Pediatric INTERMED Biological Domain Score	9.0
Pediatric INTERMED Psychological Domain Score	4.0
Pediatric INTERMED Social Domain Score	4.0
Pediatric INTERMED Caregiver/Family Domain Score	4.0
Pediatric INTERMED Health Service Domain Score	3.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Inter-rater reliability
	Estimated Value	.87
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Inter rater reliability for a subset of 40 patients whose Pediatric INTERMED was scored by two trained raters. The median inter-rater reliability coefficient was .87.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Cronbach's Alpha
	Estimated Value	.91
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Overall internal consistency of the overall Pediatric INTERMED scale (34 items).

2. Primary Outcome

Title	Correlations Between Pediatric INTERMED Domain Scores
Description	Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED domain scores.
Time Frame	Pediatric INTERMED scores at time of study participation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Biological	Psychological	Social	Family/Caregiver	Health Service
Arm/Group Description	Sum of Biological Domain Item Scores	Sum of Psychological Domain Item Scores	Sum of Social Domain Item Scores	Sum of Family/Caregiver Domain Item Scores	Sum of Health Service Domain Item Scores
Measure Participants	148	148	148	148	148
Biological	1	.29	.34	.32	.19
Psychological	.29	1	.65	.64	.42
Social	.34	.65	1	.63	.41
Caregiver/Family	.32	.64	.63	1	.53
Health Service	.19	.42	.41	.53	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD, Psychological
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	Correlation between the biological and psychological domain scores on the Pediatric INTERMED. The threshold for significance is p< .05.
	Method	Pearson Correlation Coefficients
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD, Social
	Comments	Correlation between the Biological and Social domain scores on the Pediatric INTERMED.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p< .05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD, Family/Caregiver
	Comments	Correlation between the Biological and Family/Caregiver Pediatric INTERMED domain scores.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p< .05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD, Health Service
	Comments	Correlation between Biological and Health Service Pediatric INTERMED domain scores.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p< .05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Psychological, Social
	Comments	Correlation between Psychology and Social Pediatric INTERMED domain scores.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p< .05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Psychological, Family/Caregiver
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p< .05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Psychological, Health Service
	Comments	Correlation between Pediatric INTERMED Psychological and Health Service Pediatric INTERMED domain scores.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p< .05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Social, Family/Caregiver
	Comments	Correlation between Social and Family/Caregiver Pediatric INTERMED domain scores.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p< .05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Social, Health Service
	Comments	Correlation between Social and Health Service Pediatric INTERMED domain scores.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p< .05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Family/Caregiver, Health Service
	Comments	Correlation between Family/Caregiver and Health Service Pediatric INTERMED domain scores.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p< .05.
	Method	Pearson Correlation Coefficient
	Comments

3. Primary Outcome

Title	Pediatric INTERMED Items
Description	Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items.
Time Frame	Day 1 (At time of Pediatric Intermed Interview)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Score of 0	Score of 1	Score of 2 or 3
Arm/Group Description	Rating of 0 (No Vulnerability/Need for Action) on Pediatric INTERMED Item	Rating of 1 (Mild Vulnerability/Need for watchful waiting or preventive intervention) on Pediatric INTERMED item.	Rating of 2 (Moderate Vulnerability/Need for Action or Development of an Intervention Plan) on the Pediatric INTERMED item or Rating of 3 (Severe Vulnerability/Need for Immediate Action of Intensive Action/Plans).
Measure Participants	148	148	148
Biological: Chronicity	.7 0.5%	1.4 NaN	98 NaN
Biological: Diagnostic Dilemma	.7 0.5%	20.9 NaN	78.4 NaN
Biological: Symptom Severity	26.4 17.8%	46.6 NaN	27 NaN
Biological: Diagnostic Challenge	60.8 41.1%	20.9 NaN	18.2 NaN
Biological: Therapeutic Complexity	2.7 1.8%	6.1 NaN	91.2 NaN
Biological: Complications and Life Threat	2.7 1.8%	73.6 NaN	23.7 NaN
Psychological: Barriers to Coping	37.8 25.5%	45.9 NaN	16.2 NaN
Psychological: Resiliency	43.9 29.7%	43.2 NaN	12.8 NaN
Psychological: Mental Health History	51.4 34.7%	30.4 NaN	18.2 NaN
Psychological: Cogntive/Intellectual Development	79.7 53.9%	17.6 NaN	2.7 NaN
Psychological: Adverse Developmental Events	84.5 57.1%	12.8 NaN	2.7 NaN
Psychological: Resistance to Treatment	49.3 33.3%	41.9 NaN	8.8 NaN
Psychological: Mental Health Symptoms	36.5 24.7%	53.4 NaN	10.2 NaN
Psychological: Cogntive/Functinonal Impairment	96.6 65.3%	2.7 NaN	.7 NaN
Psychological: Mental Health/Cognitive Threat	31.8 21.5%	58.1 NaN	10.1 NaN
Social: School Functionning	36.5 24.7%	43.9 NaN	19.6 NaN
Social: Social Functioning	63.5 42.9%	24.3 NaN	12.2 NaN
Social: Child/Youth Supports	77.7 52.5%	21.6 NaN	.7 NaN
Social: School Attendance	55.4 37.4%	25 NaN	19.6 NaN
Social: Educational NEeds	54.1 36.6%	27.7 NaN	18.3 NaN
Social: Community Participation	61.5 41.6%	28.4 NaN	10.2 NaN
Social System Vulnerability	37.8 25.5%	52 NaN	10.2 NaN
Family: Family Relationships	58.8 39.7%	33.1 NaN	8.1 NaN
Family: Caregiver Health/Function	45.3 30.6%	43.9 NaN	10.8 NaN
Family: Residential Stability	60.1 40.6%	33.8 NaN	6.1 NaN
Family: Caregiver/Family Support	61.5 41.6%	25.7 NaN	12.8 NaN
Family: Family Stress	14.9 10.1%	66.9 NaN	18.2 NaN
Family: Parental Skills	62.8 42.4%	34.5 NaN	2.7 NaN
Family/Caregiver System Vulnerability	39.2 26.5%	55.4 NaN	5.4 NaN
Health System: Access to Health Care	57.4 38.8%	38.5 NaN	4.1 NaN
Health System: Treatment Experience	51.4 34.7%	43.2 NaN	5.4 NaN
Health System: Organization of Care	2 1.4%	81.1 NaN	16.9 NaN
Health System: Coordination of Care	70.9 47.9%	25 NaN	4.1 NaN
Health System Impediments	34.5 23.3%	61.5 NaN	4.1 NaN

4. Primary Outcome

Title	IBD Disease Severity
Description	IBD Disease Severity Index categorizes patient's level of disease severity based on patient scores on the Pediatric Crohn's Disease Activity Index (PCDAI): (Hymans, Markowitz, Otley et al., 2005) and the Pediatric Ulcerative Colitis Activity Index (PUCAI) (Turner, Otley, Mack et al., 2007). Children's scores on either of these indices are used to categorize the severity of their disease as: inactive, mild, moderate, or severe.
Time Frame	Day 1 (Date of patient's participation in the Pediatric Intermed interview).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Disease Severity: Remission/Inactive	Disease Severity: Mild	Disease Severity: Moderate	Disease Severity: Severe
Arm/Group Description	Disease Severity classified as in remission/inactive	Disease Severity classified as mild	Disease Severity classified as moderate	Disease Severity classified as severe
Measure Participants	148	148	148	148
Disease Severity at Pediatric INTERMED Interview	62.8 42.4%	25.7 NaN	8.1 NaN	3.4 NaN
Disease Severity at Diagnosis	4.3 2.9%	25.7 NaN	32.1 NaN	37.9 NaN

5. Primary Outcome

Title	Time Since IBD Diagnosis
Description	Time since subject's initial IBD diagnosis. Data for each subject was obtained from chart review and was coded in "months since date of diagnosis", with a range from 1 - 131 months.
Time Frame	Data collected through chart review at time of Pediatric INTERMED interview.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Less Than 6 Months	6 Months-1 Year	1 Year-5 Years	Greater Than 5 Years
Arm/Group Description	Less than 6 months since initial IBD diagnosis.	6 months to 1 year since initial IBD diagnosis.	1 - 5 years since initial IBD diagnosis.	Greater than 5 years since initial IBD diagnosis.
Measure Participants	148	148	148	148
Number [Percentage of Participants]	15.5 10.5%	34.5 NaN	32.4 NaN	17.6 NaN

6. Primary Outcome

Title	Disease Course and Treatment
Description	Number of hospitalizations since diagnosis (total number recorded in health record), number of surgeries since diagnosis (total number recorded in health record), number of courses of Prednisone (total number recorded in health record).
Time Frame	Data collected through chart review with respect to the period since diagnosis and Day 1 (date that patient's participation in Pediatric Intermed interview)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Measure Participants	148
Number of Hospitalizations since Diagnosis	1
Number of Surgeries Since Diagnosis	0
Number of Courses of Prednisone	1

7. Primary Outcome

Title	IBD Treatment With Immunomodulators or Anti-TNFa Medications
Description	Use of Immunomodulators (azathioprine or methotrexate). Coded for each participant as "yes" (Score of 1) or "no" (Score of 2). Use of anti-Tumor Necrosis Factor alpha (TNFa) medications (infliximab or adalimumab). Coded for each participant as "yes" (Score of 1) or "no" (Score of 2).
Time Frame	Information from review of participants chart from time of diagnosis until study participation (date of Pediatric INTERMED interview).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Measure Participants	148
Use of Immunomodulators	55.4 37.4%
Use of anti-TNFa Medications	42.6 28.8%

8. Primary Outcome

Title	Functional Disability Inventory
Description	Functional Disability Inventory: (FDI); Walker & Greene, 1991). The FDI assesses illness related activity limitations in children and adolescents. The measure consists of 15 items that are scored by the child and parent as (0) "no trouble" to "(4) "impossible". The minimum score is 0 and the maximum score is 60, with higher scores indicating greater functional disability. The FDI has demonstrated good psychometric properties with test-retest reliability of .92 and .85 at the 3-month follow-up. Concurrent validity was provided by correlation (r=.52, p<.001) between the FDI and an objective index of disability (Walker & Greene, 1991).
Time Frame	Day 1 (Date of patient's participation in the Pediatric Intermed interview).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Measure Participants	145
FDI - Child Report	4
FDI- Parent Report	2

9. Primary Outcome

Title	Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease.
Description	35-item self report measure for assessing quality of life in children with IBD (Otley, Griffiths, Hale et al., 2006). Items are rated on a 5-point Likert scale, with lower scores indicating poorer health related quality of life. Scores can range from 35-175. Four factor scores can be calculated: General Well-Being, Emotional Functioning, Social Functioning, Body Image, as well as a Total Quality of Life Score (Perrin, Kuhlthau, Chughtai et al., 2008).
Time Frame	Day 1 (At time of Pediatric Intermed Interview)

Outcome Measure Data

Analysis Population Description

The number of participants was lower due to some missing data for this indicator, due to a few participants not completing this questionnaire.

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Measure Participants	142
Impact III: Emotional Functioning	45
Impact III: Social Interactions	22
Impact III: General Well-Being	57

10. Primary Outcome

Title	Child Behaviour Checklist
Description	Child Behaviour Checklist: (CBCL: Achenbach 1991). The CBCL is used to evaluate behaviour problems and social competencies of children 6 to 18 years old. The measure is completed by parents or parent surrogates who base their ratings on the preceding 6 months. It is comprised of 120 problem items that factor into eight syndrome scales, which can be grouped into Internalizing, Externalizing and Total Problem Scales. Higher scores indicate greater level of emotional/behavioural difficulties. In the present study we utilized the following CBCL subscale scores: Internalizing, Externalizing, Social Competence, Activities Competence, Academic Competence. All scores reported are scaled to T Scores.
Time Frame	Day 1 (Date of patient's participation in the Pediatric Intermed interview).

Outcome Measure Data

Analysis Population Description

The number of participants was lower due to some missing data for this indicator, as a result of a few parents not having completed this questionnaire.

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Measure Participants	136
CBCL Internalizing	54
CBCL Externalizing	46
CBCL Social Competence	45
CBCL Activities Competence	48
CBCL Academic Competence	50

11. Primary Outcome

Title	Children's Depression Inventory
Description	27 item self-report questionnaire used to measure depressive symptoms in children and youth (Kovacs 1992). Each item is rated on a 3-point Likert scale (0-2) with a minimum score of 0 and a maximum score of 54, with higher scores indicating more depressive symptoms. Raw scores were scaled to T-scores to control for age and gender differences.
Time Frame	Administered at study entry

Outcome Measure Data

Analysis Population Description

The number of participants was lower due to some missing data for this outcome measure, as a result of a few participants not having completed this questionnaire.

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Measure Participants	143
Median (Inter-Quartile Range) [Units on a Scale - T Scores]	42

12. Primary Outcome

Title	Multidimensional Anxiety Scale for Children
Description	Multidimensional Anxiety Scale for Children: (MASC; March et a., 1997). The MASC is a pediatric self-report scale that measures symptoms of anxiety. It consists of 39 items assessing physical symptoms of anxiety, harm avoidance, social anxiety and separation/panic. Each item is answered using a four point Likert scale ranging from (0) "never true about me" to (3) "often true about me". Total scores can range from 0 to 117. The raw total score was scaled to T-Scores to control for age and sex differences.
Time Frame	Day 1 (Date of patient's participation in the Pediatric Intermed interview).

Outcome Measure Data

Analysis Population Description

The number of participants was lower due to some missing data for this outcome measure, as a result of a few participants not having completed this questionnaire.

Arm/Group Title	Children/Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Measure Participants	145
Median (Inter-Quartile Range) [units on a scale- T scores]	50.00

13. Primary Outcome

Title	Pediatric Inventory for Parents- Difficulty Score
Description	Pediatric Inventory for parents: (PIP; Streisand et al., 2001). The PIP is a 42-item self-report measure of parenting stress associated with caring for a medically ill child. It is the only published measure of parenting stress the specifically taps the experiences and stresses that parents face when caring for a medically ill child. The Difficulty Score - indicates parents' perception of the perceived difficulty of each stressor/item. Each item is scored on a 5 point Likert scale, with total scores ranging from 42 to 210, with higher scores indicating greater "perceived difficulty".
Time Frame	Day 1 (Date of patient's participation in the Pediatric Intermed interview).

Outcome Measure Data

Analysis Population Description

The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Measure Participants	133
Median (Inter-Quartile Range) [units on a scale]	82

14. Primary Outcome

Title	Family Inventory of Life Events and Changes
Description	Family Inventory of Life Events and Changes (FILE): (McCubbin & Patterson, 1991). The FILE is a 71-item, yes/no instrument that assesses chronic and recent life stress in nine areas: intra-family strains, marital strains, pregnancy and childbearing strains, finance and business strains, work-family transitions and strains, illness and family care strains, losses, transition in and out, and family and legal violations. Family members indicate whether particular stressful events have occurred. The FILE has been found to have high reliability (Cronbach's alpha=.72), good test-retest reliability, internal consistency and evidence of construct validity. Scores can range from 0-71, with higher scores indicating greater family stress.
Time Frame	Day 1 (Date of patient's participation in the Pediatric Intermed interview).

Outcome Measure Data

Analysis Population Description

The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Measure Participants	139
Median (Inter-Quartile Range) [units on a scale]	7

15. Primary Outcome

Title	Family Inventory of Resources for Management
Description	Family Inventory of Resources for Management (FIRM): (McCubbin & Comeau 1991). The FIRM was developed to assess the family's repertoire of resources. The scale is comprised of 69 items, which are responded to using a 4-point Likert scale format (0-3). The scale has been found to have good internal reliability (r=.89, Cronbach's alpha), content and concurrent validity when used in normative sample of families with chronically ill children. The possible range for the total score is from 0-207, with higher scores indicating greater family resources for management. The Financial Well-Being subscale consists of 16 items, with potential scores ranging from 0-48, with higher scores indicating greater family financial resources.
Time Frame	Day 1 (Date of patient's participation in the Pediatric Intermed interview).

Outcome Measure Data

Analysis Population Description

The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Measure Participants	133
Firm: Total Score	127
FIRM: Financial Well-being Scale	36

16. Primary Outcome

Title	Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning
Description	Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domains and items. Refer to Outcome Measure 4 for information pertaining to IBD Disease Severity. Refer to Outcome Measure 5 for information pertaining to Disease Treatments. Refer to Outcome Measure 8 for information pertaining to Functioning Disability Inventory. Refer to Outcome Measure 9 for information pertaining to the IMPACT III- Quality of Life Questionnaire.
Time Frame	Pediatric INTERMED and Functioning at study participation and Disease related indices since IBD Diagnosis

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pediatric INTERMED Biological Domain Score	Historical Biological Item: Chronicity	Historical Biological Item: Diagnostic Dilemma	Current Biological Item: Symptom Severity	Current Biological Item: Diagnostic/Therapeutic Challenge	Current Biological Item: Therapeutic Complexity	Vulnerability Biological Item: Complications and Life Threat
Arm/Group Description	Sum of all Pediatric INTERMED Biological domain item scores.	This item taps the extent and chronicity of child's physical health issues.	This item taps whether or not the child/youth has been seeking care for physical complaints across a substantial portion of their life and whether or not these complaints have been resolved.	This item taps the severity/acuity of the child's current physical symptoms, and the extent to which they impact on current functioning.	This item refers to the presence of physical symptoms that result in current diagnostic questions or therapeutic challenges.	This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.	This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
Measure Participants	148	148	148	148	148	148	148
Disease Severity at Diagnosis	-.06	.06	-.12	.09	-.15	.04	-.02
Disease Severity at Study Enrolment	.36	.01	-.08	.53	.20	.17	.18
Functional Disability Index- Child Rating	.50	.16	.00	.56	.20	.03	.23
Functional Disability Index - Parent Rating	.52	.27	-.10	.51	.14	.09	.27
Impact III: General Well-Being Scale	-.45	-.05	.03	-.65	-.24	-.01	-.17
Number of Surgeries since Diagnosis	.00	.10	.15	.02	.09	-.14	.13
Number of Courses of Prednisone since Diagnosis	.10	.08	.06	-.01	-.10	.18	-.07
Use of Chemical Immunomodulators since Diagnosis	-.11	-.18	-.11	.16	.07	-.42	-.20
Use of Biological Immunodulators Since Diagnosis	-.09	.13	-.04	-.09	.12	-.32	-.06

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity at Diagnosis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity (at time of Study Participation).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p< .05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (child rating).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p< .05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (parent rating).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Biological Domain Score and Impact Quality of Life: General Well Being scale.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Biological Domain Score and Number of Surgeries.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Biological Domain Score and Number of Courses of Prednisone.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Biological Domain Score and Use of Immunomodulators.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Biological Domain Score and Use of ant-TNFa medications.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at Diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Child Report)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Parent)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Impact Quality of Life: General Well-Being.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Surgeries.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Courses of Prednisone.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Use of Immunomodulators (azathioprine or methotrexate)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The threshold for significance is p< 0.05.
	Method	Spearman Correlation Coefficent
	Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and use of anti-TNFa medications.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Family/Caregiver
	Comments	Correlation between Pediatric INTERMED "Symptom Severity" Item (Current/Biological) and Disease Severity at Diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Family/Caregiver
	Comments	Correlation between Pediatric INTERMED "Symptom Severity" Item (Current Biological) and IBD Disease Severity at time of study participation.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Family/Caregiver
	Comments	Correlation between Pediatric INTERMED "Symptom Severity" Item (Current Biological) and Functional Disability Index (child rating).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Family/Caregiver
	Comments	Correlation between Pediatric INTERMED "Symptom Severity" Item (Current Biological) and Functional Disability Index (Parent Rating)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Family/Caregiver
	Comments	Correlation between Pediatric INTERMED "Symptom Severity" Item (Current Biological) and Impact Quality of Life: General Well-Being Scale
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Family/Caregiver
	Comments	Correlation between Pediatric INTERMED "Symptom Severity" Item (Current/Biological) and Number of Surgeries
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Family/Caregiver
	Comments	Correlation between Pediatric INTERMED "Symptom Severity" Item (Current/Biological) and Number of Courses of Prednisone.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Family/Caregiver
	Comments	Correlation between Pediatric INTERMED "Symptom Severity" Item (Current/Biological) and Use of Immunomodulators.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Family/Caregiver
	Comments	Correlation between Pediatric INTERMED "Symptom Severity" Item (Current/Biological) and Use of anti-TNFa Medications.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlations between Pediatric INTERMED "Diagnostic Dilemma" Item (Historical Biological) and Functional Disability Index (Parent) and each of the following variables: Disease Severity at Diagnosis, Disease Severity at Interview, Functional Disability Index - Child, Functional Disability Index- Parent, Impact Quality of Life: General Well Being, Number of Surgeries, Number of Courses of Prednisone, Use of Immunomodulators, Use of Anti-TNFa Medications.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05. The P-Value indicated above was found for all the correlations which were examined.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	Health Service
	Comments	Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and IBD Disease Severity at Diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	Health Service
	Comments	Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and IBD Disease Severity at time of study participation.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	Health Service
	Comments	Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and Functional Disability Index (Child Rating)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	Health Service
	Comments	Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and Functional Disability Index (parent rating).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	Health Service
	Comments	Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and Impact Quality of LIfe: General Well-Being Scale
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	Health Service
	Comments	Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and Number of Surgeries.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	Health Service
	Comments	Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and Number of Courses of Prednisone.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	Health Service
	Comments	Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and Use of Immunomodulators. .
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	Health Service
	Comments	Correlation between Pediatric INTERMED "Diagnostic/Therapeutic Challenge" Item (Current Biological) and Use of anti-TNFa Medications
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	Current Biological Item: Therapeutic Complexity
	Comments	Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Disease Severity at Diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	Current Biological Item: Therapeutic Complexity
	Comments	Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	Current Biological Item: Therapeutic Complexity
	Comments	Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Functional Disability Index (Child Rating).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 41

Statistical Analysis Overview	Comparison Group Selection	Current Biological Item: Therapeutic Complexity
	Comments	Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Functional Disability Index (Parent Rating)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 42

Statistical Analysis Overview	Comparison Group Selection	Current Biological Item: Therapeutic Complexity
	Comments	Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Impact Quality of Life: General Well-Being
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 43

Statistical Analysis Overview	Comparison Group Selection	Current Biological Item: Therapeutic Complexity
	Comments	Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Number of Surgeries.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 44

Statistical Analysis Overview	Comparison Group Selection	Current Biological Item: Therapeutic Complexity
	Comments	Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Number of Courses of Prednisone since diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 45

Statistical Analysis Overview	Comparison Group Selection	Current Biological Item: Therapeutic Complexity
	Comments	Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Use of Immunomodulators (azathioprine or methotrexate).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significiance is p<0.01.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 46

Statistical Analysis Overview	Comparison Group Selection	Current Biological Item: Therapeutic Complexity
	Comments	Correlation between Pediatric INTERMED "Therapeutic Complexity" Item (Current Biological) and Use of ant-TNFa Medications (infliximab or adalimumab).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The Threshold for significance is p<0.05)
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 47

Statistical Analysis Overview	Comparison Group Selection	Vulnerability Biological Item: Complications and Life Threat
	Comments	Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Disease Severity at diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 48

Statistical Analysis Overview	Comparison Group Selection	Vulnerability Biological Item: Complications and Life Threat
	Comments	Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Disease Severity at study participation.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 49

Statistical Analysis Overview	Comparison Group Selection	Vulnerability Biological Item: Complications and Life Threat
	Comments	Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Functional Disability Index (Child Rating).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 50

Statistical Analysis Overview	Comparison Group Selection	Vulnerability Biological Item: Complications and Life Threat
	Comments	Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Functional Disability Index (parent rating).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.01.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 51

Statistical Analysis Overview	Comparison Group Selection	Vulnerability Biological Item: Complications and Life Threat
	Comments	Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Impact Quality of Life: General Well Being Scale.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 52

Statistical Analysis Overview	Comparison Group Selection	Vulnerability Biological Item: Complications and Life Threat
	Comments	Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Number of Surgeries.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 53

Statistical Analysis Overview	Comparison Group Selection	Vulnerability Biological Item: Complications and Life Threat
	Comments	Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Number of Courses of Prednisone.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 54

Statistical Analysis Overview	Comparison Group Selection	Vulnerability Biological Item: Complications and Life Threat
	Comments	Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Use of Immunomodulators (azathioprine or methotrexate).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 55

Statistical Analysis Overview	Comparison Group Selection	Vulnerability Biological Item: Complications and Life Threat
	Comments	Correlation between Pediatric INTERMED "Complications and Life Threat" Item (Vulnerability Biological) and Use of anti-TNFa Medications.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

17. Primary Outcome

Title	Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning.
Description	Relations between Pediatric INTERMED Psychological, Social and Family Domain scores and other validated measures of subjects' psychosocial adjustment, including depression (Children's Depression Inventory- Outcome Measure 11), anxiety (Multidimensional Anxiety Scale for Children-Outcome Measure 12), Behavioural Adjustment (Internalizing and Externalizing Scores on the CBCL- Outcome Measure 10), Competence (Social, Activities and School Competence Scores from the CBCL- Outcome Measure 10), and family functioning (Parenting Inventory for Parents- Outcome Measure 13, Family Inventory of Life Events-Outcome Measure 14, Family Inventory of Resources for Management- Outcome Measure 15), and IBD health-related quality of life (IMPACT III: Emotional Functioning and Social Interactions scales- Outcome Measure 9).
Time Frame	Day 1 (Time of Study Participation)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pediatric INTERMED Psychological Domain Score	Pediatric INTERMED Social Domain Score	Pediatric INTERMED Caregiver/Family Domain Score
Arm/Group Description	Sum of Pediatric INTERMED Psychological Domain item scores	Sum of Pediatric INTERMED Social Domain items scores	Sum of Pediatric INTERMED Caregiver/Family Domain item scores
Measure Participants	133	133	133
CBCL Internalizing Score	.56	.46	.46
CBCL Externalizing Score	.52	.42	.38
Children's Depression Inventory	.41	.46	.38
Multidimensional Anxiety Scale for Children	.24	.19	.14
Impact III: Emotional Functioning	-.35	-.30	-.33
CBCL Social Competence	-.32	-.38	-.29
CBCL Activities Competence	-.18	-.23	-.27
CBCL Academic Competence	-.50	-.59	-.35
Impact III: Social Interactions	.40	-.38	-.37
PIP Difficulty Score	.22	.41	.39
Family Inventory of Life Events	.31	.36	.41
Family Inventory of Resources for Management	-.26	-.28	-.46

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Internalizing Problems (Child Behaviour Checklist).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Externalizing Problems (Child Behaviour Checklist).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Children's Depression Inventory: Total Score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Multidimensional Anxiety Scale for Children: Total Score.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The threshold for significance is p<0.05
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scale
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Social Competence Scale (Child Behaviour Checklist).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Activities Competence Scale (Child Behaviour Checklist).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Academic Competence Scale (Child Behaviour Checklist).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Social Scale
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Resources for Management (family resources measure).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Social Domain Score (social needs) and Internalizing Problems (Child Behaviour Checklist).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Social Domain Score (social needs) and Externalizing Problems (Child Behaviour Checklist).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Social Domain Score (social needs) and Children's Depression Inventory: Total Score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Social Domain Score (social needs) and Multidimensional Anxiety Scale for Children: Total Score.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Emotional Scale
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Social Domain Score (social needs) and Social Competence Scale (Child Behaviour Checklist).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Social Domain Score (social needs) and Activities Competence Scale (Child Behaviour Checklist).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Social Domain Score (social needs) and Academic Competence Scale (Child Behaviour Checklist).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Social Scale
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Social Domain Score (social needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Life Events (family stress measure).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Resources for Management (family resources measure).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Internalizing Problems (Child Behaviour Checklist).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Externalizing Problems (Child Behaviour Checklist).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Children's Depression Inventory: Total Score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Multidimensional Anxiety Scale for Children: Total Score.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scale
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Social Competence Scale (Child Behaviour Checklist).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Activities Competence Scale (Child Behaviour Checklist).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Academic Competence Scale (Child Behaviour Checklist).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Impact Quality of Life: Social Scale
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Family Inventory of Resources for Management (family resources measure).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

18. Primary Outcome

Title	Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range.
Description	This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat item when they scored in the clinical range on the Multidimensional Anxiety Scale for Children. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 12 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Multidimensional Anxiety Scale for Children were categorized as falling into the clinical range.
Time Frame	Day 1 (At time of Pediatric Intermed Interview)

Outcome Measure Data

Analysis Population Description

The number of participants was lower due to some missing data for the MASC measure, due to fewer participants completing this questionnaire.

Arm/Group Title	Subjects With MASC Scores in the Clinical Range.	Subjects With MASC Scores in the Non-clinical Range
Arm/Group Description	Children whose scores on the Multidimensional Anxiety Scale for Children fell within the clinical range.	Children whose scores on the Multidimensional Anxiety Scale for Children fell below the clinical range.
Measure Participants	145	145
Mental Health/Cognitive Vulnerability Need	4 2.7%	10 NaN
No Mental Health/Cognitive Vulnerability	6 4.1%	125 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD, Psychological
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	8.33
	Confidence Interval	(2-Sided) 95%; 2.02 to 34.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

19. Primary Outcome

Title	Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range.
Description	This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Children's Depression Inventory. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 11 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Children's Depression Inventory were categorized as falling into the clinical range.
Time Frame	Day 1 (At time of Pediatric Intermed Interview)

Outcome Measure Data

Analysis Population Description

The number of participants was lower due to some missing data for the CDI measure, due to fewer participants completing this questionnaire.

Arm/Group Title	Subjects With CDI Scores in the Clinical Range.	Subjects With CDI Scores in the Non-clinical Range
Arm/Group Description	Children whose scores on the Children's Depression Inventory fell within the clinical range.	Children whose scores on the Children's Depression Inventory fell below the clinical range.
Measure Participants	143	143
Mental Health/Cognitive Vulnerability Need	3 2%	11 NaN
No Mental Health/Cognitive Vulnerability	4 2.7%	125 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD, Psychological
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	8.52
	Confidence Interval	(2-Sided) 95%; 1.70 to 43.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

20. Primary Outcome

Title	Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range.
Description	This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Internalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Internalizing Scale were categorized as falling into the clinical range.
Time Frame	Day 1 (At time of Pediatric Intermed Interview)

Outcome Measure Data

Analysis Population Description

The number of participants was lower due to some missing data for the CBCL measure, due to fewer participants completing this questionnaire.

Arm/Group Title	CBCL Internalizing Score in the Clinical Range.	CBCL Internalizing Score in the Non-clinical Range
Arm/Group Description	Children whose scores on the CBCL Internalizing Scale fell within the clinical range.	Children's whose scores on the CBCL Internalizing Scale fell below the clinical range.
Measure Participants	135	135
Mental Health/Cognitive Vulnerability Need	8 5.4%	5 NaN
No Mental Health/Cognitive Vulnerability	22 14.9%	100 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD, Psychological
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	7.27
	Confidence Interval	(2-Sided) 95%; 2.17 to 24.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

21. Primary Outcome

Title	Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range.
Description	This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Externalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Externalizing Scale were categorized as falling into the clinical range.
Time Frame	Day 1 (At time of Pediatric Intermed Interview)

Outcome Measure Data

Analysis Population Description

The number of participants was lower due to some missing data for the CBCL measure, due to fewer participants completing this questionnaire.

Arm/Group Title	CBCL Externalizing Score in the Clinical Range.	CBCL Externalizing Score in the Non-clinical Range
Arm/Group Description	Children whose scores on the CBCL Externalizing scale fell within the clinical range.	Children whose scores on the CBCL Externalizing Scale fell below the clinical range.
Measure Participants	135	135
Mental Health/Cognitive Vulnerability Need	5 3.4%	8 NaN
No Mental Health/Cognitive Vulnerability	3 2%	119 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD, Psychological
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	24.79
	Confidence Interval	(2-Sided) 95%; 5.00 to 122.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

22. Primary Outcome

Title	Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators
Description	Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domain scores and items. Refer to Outcome Measure 6 for information pertaining to Disease/Treatment Indicators. Refer to Outcome Measure 23 for information about the Number of Services involved in Child's Care, and to Outcome Measure 15 for information about the Family Inventory of Resources for Management.
Time Frame	Pediatric INTERMED and FIRM scores obtained at Study Entry and Disease and Health Care Indicators since IBD Diagnosis

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pediatric Intermed: Health System Domain Score	Historical Health System Item: Access to Health Care	Historical Health System Item: Treatment Experience	Current Health System Item: Organization of Care	Current Health System Item: Coordination of Care	Vulnerability Health System Item: Health System Impediments
Arm/Group Description	Sum of Pediatric INTERMED health system item scores.	This item refers to anything in the past that served as an obstacle, hindering the patient's access to healthcare.	This item describes the degree to which the child and family's prior health care experiences have been positive in terms of good outcomes and relationships with health care providers.	This item describes the nature and organization of the health care services that the child is current receiving.	This item describes the extent to which the different health care providers working with the child are in contact with each other.	This item anticipates the problems that the child/youth may encounter in the next 3-6 months in receiving the services he/she requires.
Measure Participants	148	148	148	148	148	148
Number of Services involved in Child's Care	.26	.08	.25	.37	.20	.15
Number of Hospitalizations since Diagnosis	.34	.36	.14	.11	.09	.23
Numbers of Surgeries since Hospitalization	.22	.25	.10	.08	.13	.11
FIRM: Financial Well Being Scale	-.32	-.34	-.13	-.03	-.15	-.36

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Hospital Services involved in the child's care.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Inpatient Hospitalizations since IBD diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Surgeries since IBD diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Family Financial Well Being
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Pearson Correlation Coefficient
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED "Access to Health Care" Item (historical/health system) and Number of Hospital Services Involved in the Child's Care.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED "Access to Health Care" Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED "Access to Health Care" Item (historical/health system) and Number of Surgeries since Diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Psychological
	Comments	Correlation between Pediatric INTERMED "Access to Health Care" Item (historical/health system) and Family Financial Well-Being.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlation between Pediatric INTERMED "Treatment Experience" Item (historical/health system) and Number of Hospital Services Involved in the Child's Care.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlation between Pediatric INTERMED "Treatment Experience" Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlation between Pediatric INTERMED "Treatment Experience" Item (historical/health system) and Number of Surgeries since child's diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Social
	Comments	Correlation between Pediatric INTERMED "Treatment Experience" Item (historical/health system) and Family Financial Well-Being.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Family/Caregiver
	Comments	Correlation between Pediatric INTERMED "Organization of Care" Item (current/health system) and Number of Hospital Services Involved in the Child's Care.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Family/Caregiver
	Comments	Correlation between Pediatric INTERMED "Organization of Care" Item (current/health system) and Number of Hospitalizations since IBD Diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Family/Caregiver
	Comments	Correlation between Pediatric INTERMED "Organization of Care" Item (current/health system) and Number of Surgeries since Child's IBD Diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Family/Caregiver
	Comments	Correlation between Pediatric INTERMED "Organization of Care" Item (current/health system) and Family Financial Well-Being.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Health Service
	Comments	Correlation between Pediatric INTERMED "Coordination of Care" Item (current/health system) and Number of Hospital Services Involved in the Child's Care.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Health Service
	Comments	Correlation between Pediatric INTERMED "Coordination of Care" Item (current/health system) and Number of Hospitalizations since Child's IBD Diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Health Service
	Comments	Correlation between Pediatric INTERMED "Coordination of Care" Item (current/health system) and Number of Surgeries Child's IBD Diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Health Service
	Comments	Correlation between Pediatric INTERMED "Coordination of Care" Item (current/health system) and Family Financial Well Being.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Current Biological Item: Therapeutic Complexity
	Comments	Correlation between Pediatric INTERMED "Health System Impediments" Item (vulnerability/health system) and Number of Hospital Services Involved in the Child's Care.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Current Biological Item: Therapeutic Complexity
	Comments	Correlation between Pediatric INTERMED "Health System Impediments" Item (vulnerability/health system) and Number of Hospitalizations since Child's IBD Diagnosis. Services Involved in the Child's Care.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Current Biological Item: Therapeutic Complexity
	Comments	Correlation between Pediatric INTERMED "Health System Impediments" Item (vulnerability/health system) and Number of Surgeries since Child's IBD Diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Current Biological Item: Therapeutic Complexity
	Comments	Correlation between Pediatric INTERMED "Health System Impediments" Item (vulnerability/health system) and Family Financial Well-Being.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for significance is p<0.05.
	Method	Spearman Correlation Coefficient
	Comments

23. Primary Outcome

Title	Total Number of Hospital Services Involved in Child's Care.
Description	Measure of number of hospital services involved in each child's care during the three month period prior to the Pediatric INTERMED interview.
Time Frame	Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Measure Participants	148
Median (Full Range) [R Square change statistic]	2.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	p<0.05 Threshold for statistical significance
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Rsquare change statistic
	Estimated Value	0.08
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

24. Primary Outcome

Title	Number of Calls to IBD Nurse
Description	Total number of calls made by patient or parent to the IBD clinic nurse during the 3-month period prior to the Pediatric Intermed Interview
Time Frame	Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Measure Participants	148
Median (Full Range) [Number of calls]	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of calls to the IBD Nurse. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	Threshold for statistical significance is p<0.01
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	R2Change
	Estimated Value	.05
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

25. Primary Outcome

Title	Number of Extra Appointments With the IBD Team
Description	Number of extra appointments (unscheduled, emergency) with the IBD Team during the 3 month period prior to the Pediatric INTERMED interview.
Time Frame	Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Measure Participants	148
Median (Full Range) [Number of appointments]	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of extra appointments with the IBD team. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	p<.05 threshold for statistical significance
	Method	Regression, Linear
	Comments	Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.
Method of Estimation	Estimation Parameter	Rsquare change statistic
	Estimated Value	.05
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

26. Primary Outcome

Title	Number of Visits to the Hospital Emergency Department
Description	Number of times that the patient visited the hospital Emergency Department in the 3-month period prior to the Pediatric INTERMED interview.
Time Frame	Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Measure Participants	148
Median (Full Range) [Emergency Department Visits]	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of ER Visits. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	Threshold for statistical significance is p <0.05.
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	R2Change
	Estimated Value	.03
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

27. Primary Outcome

Title	Number of Inpatient Hospital Admissions
Description	Total number of times that the patient was admitted to hospital during the 3-month period prior to the Pediatric INTERMED Interview.
Time Frame	Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
Measure Participants	148
Median (Full Range) [Number of hospital admissions]	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Children and Youth With IBD
	Comments	A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	R2Change
	Estimated Value	.07
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	At time of study participation and for 6 months following this.
Arm/Group Title	Children and Youth With IBD
Arm/Group Description	Children/youth (ages 8-17) with confirmed diagnoses of IBD.
All Cause Mortality
	Children and Youth With IBD
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Children and Youth With IBD
	Affected / at Risk (%)	# Events
Total	0/148 (0%)
Other (Not Including Serious) Adverse Events
	Children and Youth With IBD
	Affected / at Risk (%)	# Events
Total	0/148 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.