PHU: Mental Health in Children and Youth Within Pediatric Care

Sponsor
Region Skane (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04094324
Collaborator
(none)
200
2
27
100
3.7

Study Details

Study Description

Brief Summary

Over the last decades, there has been an increase in the number of children and youth with mental illness, such as anxiety and depression. Mental illness in youth has a strong negative influence on the youth's quality of life and generally leads to dysfunction in several important areas, such as school and social activities. Early detection and treatment of mental illness entails great treatment benefits, and thus provide opportunity to prevent or reduce individual suffering.

Youth who suffer från Medical conditions, such as diabetes, epilepsy, gastro-intestinal disease, and obesity, show an increased risk of developing mental illness. There are well-established, careful programs for examining somatic co-morbidities to diseases in children and youth. Currently, despite the fact that mental illness is more common in these children than medical sequelae and despite that such a procedure is recommended, no routine exist for examining mental health in children and youth presenting for treatment at pediatric clinics in Skåne. The absence of such a general screening entails that mental illness rarely is recognized by medical care providers until it has become severe.

The purpose of this study is to describe the prevalence of mental illness in children and adolescents, 11-18 years of age, that undergo Medical treatment at a Clinic for children and youth. Groups recruited for the first part of the study are obesity clinics and gastro clinics. In addition, we want to examine if mental health affects outcome success in their medical treatment. The long-term main objective of this project is early discovery and treatment of mental illness in somatically ill children and youth, thereby preventing the development of severe mental illness, and to reduce suffering.

By the end of the project we will have a well-functioning routine for examining mental health status in 11-18 years olds that present for and undergo treatment in Clinics for children and youth in Skåne. Furthermore, we hope that the screening tool can contribute to, and affect, nationally established guide-lines regarding the discovery and treatment of mental illness in children and adolescents within pediatric care.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Questionnaires

Detailed Description

Children and youth, 11-18 years of age, that receive treatment for obesity or Irritable Bowel Disease (IBD), will be asked to fill out three questionnaires on an iPad during a regular visit at their clinic. Information about the study will be sent home before the visit, and will be repeated again at the clinic.

The questionnaires takes about 10-15 minutes in total to answer, and the Child will be able to sit in a separate room while answering. The questionnaires are well validated screening tools for various forms of mental illness; General anxiety disorder 7 item scale (GAD-7) (anxiety), Psycic Health questionnaire 8 items (PHQ-8) (depression), The Child Eating Disorder Examination 8 items (ChEDE-Q8) (eating habits), and Pediatric quality of Life inventory (PedsQL).

Patients that receive high scores will be offered a psychologist appointment for further evaluation and treatment (e. g. individual- or family centered therapy).

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Mental Health in Children and Youth Within Pediatric Care.
Anticipated Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Children and youth at obesity clinic

Children 11-18 who are patients at obesity clinics in region Skåne SUS.

Behavioral: Questionnaires
4 questionnaires will be answered via iPads

Children and youth at a pediatric gastrointestinal clinic

Children 11-18 who are patients at a gastrointestinal clinic i region Skåne SUS.

Behavioral: Questionnaires
4 questionnaires will be answered via iPads

Outcome Measures

Primary Outcome Measures

  1. The Eating Disorder Examination-Questionnaire for children (ChEDE-Q8) [2020-2022]

    Self-reported eating habits Minimum maximum score: 0-6 Total: 48 Better or worse score: 0= never (no problematic eating habits) 6=daily (very problematic eating habits). High svore = very problematic eating habits

  2. The psychic health questionnaire 8 items (PHQ-8) [2020-2022]

    Self-reported signs of depression Minimum maximum score: 0-3 Total: 24 Better or worse score: 0= never (never experiences depressive thoughts) 4=daily (experiences depressive thoughts daily). High score = high levels of depression

  3. General anxiety scale 7 items (GAD-7) [2020-2022]

    Self-reported signs of anxiety Minimum maximum score: 0-3 Total: 21 Better or worse score: 0= never (never experiences anxiety) 4=daily (experiences anxiety daily). High score = excessive feelings of anxiety

  4. Pediatric quality of Life scale (PedsQL) 23 items [2020-2022]

    Self-reported quality of life. Measures feelings of generel well-being Minimum maximum score: 0-4 Total: 92 Better or worse score: 0= never (never experiences well-being) 4=daily (experiences well-being daily). High score = good genereal well-being

  5. Changes in ISO-BMI [2021-2022]

    Measures treatment outcome in obese Children by comparing ISO-BMi levels 1y apart.

  6. Changes in F-kalprotectin levels [2021-2022]

    Measures treatment outcome in Children with iriitable bowel disease (IBD) by comparing levels 1y apart.

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Children and youth who are patients at a pediatric clinic in Region Skåne SUS(obesity, gatronomy)
Exclusion Criteria:

Children who are unable to reply qustions on an iPad, due to language difficulties or cognitive challenges.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Helsingborgs lasarett BUM Helsingborg Sweden
2 BÖE SUS Malmö Sweden

Sponsors and Collaborators

  • Region Skane

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Region Skane
ClinicalTrials.gov Identifier:
NCT04094324
Other Study ID Numbers:
  • HBG/MMÖ PED2019
First Posted:
Sep 18, 2019
Last Update Posted:
Oct 12, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Region Skane
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2020