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).
