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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04094324
Other study ID # HBG/MMÖ PED2019
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date December 31, 2025

Study information

Verified date October 2023
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 11 Years to 18 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
Questionnaires
4 questionnaires will be answered via iPads

Locations

Country Name City State
Sweden Helsingborgs lasarett BUM Helsingborg
Sweden BÖE SUS Malmö

Sponsors (1)

Lead Sponsor Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Eating Disorder Examination-Questionnaire for children (ChEDE-Q8) 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 2020-2022
Primary The psychic health questionnaire 8 items (PHQ-8) 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 2020-2022
Primary General anxiety scale 7 items (GAD-7) 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 2020-2022
Primary Pediatric quality of Life scale (PedsQL) 23 items 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 2020-2022
Primary Changes in ISO-BMI Measures treatment outcome in obese Children by comparing ISO-BMi levels 1y apart. 2021-2022
Primary Changes in F-kalprotectin levels Measures treatment outcome in Children with iriitable bowel disease (IBD) by comparing levels 1y apart. 2021-2022
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