NCT04094324

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

5.3 years

First QC Date

April 3, 2019

Last Update Submit

October 19, 2023

Conditions

Keywords

Mental health, pediatric medicine, obesity, IBD

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • Changes in ISO-BMI

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

    2021-2022

  • Changes in F-kalprotectin levels

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

    2021-2022

Study Arms (2)

Children and youth at obesity clinic

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

Behavioral: Questionnaires

Children and youth at a pediatric gastrointestinal clinic

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

Behavioral: Questionnaires

Interventions

QuestionnairesBEHAVIORAL

4 questionnaires will be answered via iPads

Children and youth at a pediatric gastrointestinal clinicChildren and youth at obesity clinic

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and youth (11-18y) who are patients at a pediatric clinic in Region Skåne SUS (obesity, gatronomy).

You may qualify if:

  • \- Children and youth who are patients at a pediatric clinic in Region Skåne SUS(obesity, gatronomy)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Helsingborgs lasarett BUM

Helsingborg, Sweden

Location

BÖE SUS

Malmo, Sweden

Location

MeSH Terms

Conditions

Pediatric ObesityPsychological Well-BeingObesity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2019

First Posted

September 18, 2019

Study Start

October 1, 2020

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations