Internet-Delivered CBT for Children With Functional Abdominal Pain Disorders
Study Details
Study Description
Brief Summary
This randomized controlled study aims to evaluate the efficacy of exposure-based Internet-delivered cognitive behavior therapy for children 8-12 years with Functional Abdominal Pain Disorders. The children participate along with their parents, who will also receive specific modules with information on how to support their children in the treatment. Predictors and mediators for treatment effects will be studied as well as the cost effectiveness of the intervention.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Internet-delivered CBT Children and parents will receive 10 weekly modules of cognitive behavior therapy (CBT). Parents will also receive 10 weekly modules. Main components in the children's modules are exposure for abdominal symptoms, feared stimuli and situations in which the children are afraid of having symptoms. The parental receive information on how they can support their children in the treatment and how to reinforce health y behaviors and decrease attention to pain behaviors. Therapist support is provided through written messages within the secure platform. |
Behavioral: Internet-delivered Cognitive behavior therapy
The treatment is delivered via an online platform and is based on interventions for adults, adolescents and children tested in previous trials. Therapists are CBT-psychologists och students in clinical psychology under supervision.
|
| No Intervention: Waiting list This is a wait-list control where the children and parents are allowed to carry on with any contacts within the health-care system, exempt for psychological treatments. |
Outcome Measures
Primary Outcome Measures
- PedsQL Gastro [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Secondary Outcome Measures
- Faces Pain Rating Scale [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in pain intensity measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- Faces Pain Rating Scale [Weekly during treatment (treatment week 1-9).]
Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
- Faces Pain Rating Scale rated by parents [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in child's pain intensity measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- Faces Pain Rating Scale rated by parents [Weekly during treatment (treatment week 1-9).]
Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
- PedsQL Gastro rated by parents [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in child gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- PedsQL Gastro rated by parents [Weekly during treatment (treatment week 1-9).]
Change in child gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation.
- Pediatric quality of life inventory (PedsQL QOL) [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in quality of life measured measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- Pediatric quality of life inventory (PedsQL QOL) rated by parents [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in child quality of life measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- Painfree days [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in pain free days measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- Painfree days [Weekly during treatment (treatment week 1-9)]
Change in pain free days measured with a self-rating scale weekly during treatment for mediation analyses.
- Painfree days rated by parents [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in child's pain free days measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- Painfree days rated by parents [Weekly during treatment (treatment week 1-9)]
Change in child's pain free days measured with a self-rating scale weekly during treatment for mediation analyses.
- IBS-Behavioral responses questionnaire (IBS-BRQ) [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in childs behavioral responses to abdominal symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- IBS-Behavioral responses questionnaire (IBS-BRQ) [Weekly during treatment (treatment week 1-9)]
Change in child's behavioral responses to abdominal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
- IBS-Behavioral responses questionnaire (IBS-BRQ) parental version [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in child's behavioral responses to abdominal symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- IBS-Behavioral responses questionnaire (IBS-BRQ) parental version [Weekly during treatment (treatment week 1-9)]
Change in child's behavioral responses to abdominal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
- Spence Children Anxiety Scale - short version (SCAS-S) [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in child's anxiety symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- Spence Children Anxiety Scale - short version (SCAS-S) rated by parents [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in child's anxiety symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- Child Depression Inventory - short version (CDI-S) [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in child's depressive symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- Visceral Sensitivity Index [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in visceral sensitivity measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- Visceral Sensitivity Index [Weekly during treatment (treatment week 1-9)]
Change in visceral sensitivity measured with a self-rating scale weekly during treatment for mediation analyses.
- Client Satisfactory Questionnaire (CSQ) [At week 10]
Client satisfaction rated measured with a self-rating scale
- Client Satisfactory Questionnaire (CSQ) rated by parents [At week 10]
Client satisfaction rated measured with a self-rating scale
- Subjective Assessment Questionnaire (SAQ) [At week 10]
Subjective change in symptoms measured with a self-rating scale
- Subjective Assessment Questionnaire (SAQ) rated by parents [At week 10]
Subjective change in the child's symptoms measured with a self-rating scale by the parents.
- Rome-IV questionnaire [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in diagnostic status of functional abdominal pain disorder measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- Kidscreen [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in quality of life for use in economic evaluation measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- School absenteeism rated by parents [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in child's school absenteeism measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- School absenteeism rated by parents [Weekly during treatment (treatment week 1-9)]
Change in child's school absenteeism measured with a self-rating scale weekly during treatment for mediation analyses.
- Pain Catastrophizing Scale, parental version (PCS-P) [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in parental catastrophizing of the child's symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- Pain Catastrophizing Scale, parental version (PCS-P) [Weekly during treatment (treatment week 1-9)]
Change in parental catastrophizing of the child's symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
- Children´s Somatization Inventory (CSI 24) rated by parents [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in child's somatization symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- Adverse events (AE) [At week 10]
Adverse events during treatment measured with a self-rating scale by the parents.
- Working Alliance Inventory (WAI) short version [At week 4]
Working alliance in first three weeks of treatment measured with a self-rating scale by the parents.
- The treatment credibility scale rated by parents. [At week 2]
Treatment credibility measured with a self-rating scale by the parents.
- Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) rated by parents [Baseline, at weeks 3, 7, 10 and at 9 months]
Costs associated with the disorder measured with a self-rating scale by the parents.
- General health questionnaire (GHQ-12) rated by parents [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in general health measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- Generalised anxiety disorder assessment (GAD 7) rated by parents [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in parental anxiety symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- Adult responses to children's symptoms (ARCS) rated by parents [Baseline to 10 weeks, baseline to 9 months, baseline to 15 months]
Change in parental responses to child's symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
- Adult responses to children's symptoms (ARCS) rated by parents [Weekly during treatment (treatment week 1-9)]
Change in parental responses to child's symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
- PedsQL Gastro [Weekly during treatment (treatment week 1-9).]
Change in gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Children 8-12 years with either irritable bowel syndrome, functional dyspepsia or functional abdominal pain - not otherwise specified diagnosed according to Rome-III or Rome-IV criteria.
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Psychopharmacological medication stable for at least a month if medicating.
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Child and at least one parent speaking and writing swedish.
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Access to computer with Internet connection.
Exclusion Criteria:
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Severe somatic disorder and/or if the child fulfills criteria of other disorder that better explains the abdominal symptoms.
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Severe psychiatric or social problems that needs other care.
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Ongoing psychological treatment.
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School absenteeism more than 40 %.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Child and Adolescent Psychiatry in Stockholm | Stockholm | Sweden | 11330 |
Sponsors and Collaborators
- Karolinska Institutet
Investigators
- Principal Investigator: Ola Olén, MD PhD, Karolinska Institutet
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RCT ICBT FAPD