Mind the Heart - Mental Health in Children and Adolescents With Congenital Heart Defects
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-17
SponsorRigshospitalet, Denmark
About this trial
The aim of the Mind the Heart study is to document the feasibility of an online parent/child administered screening model for mental disorders (MDs) in Danish children and adolescents with congenital heart disease (CHD). As MDs in children and adolescents with chronic somatic health issues are frequently underdiagnosed and undertreated, we further aim to develop a website with evidence based information on mental health in children and adolescents with CHD in order to promote knowledge and awareness among families and health professionals across sectors.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Born with a Congenital Heart Defect
Age 5-17y
(Living in Denmark)
Disqualifiers
Younger than 5years of age
Older than 17years of age
Lacking sufficient Danish language skills to answer the questionnaire
Trial population
The population will be selected though the Danish registries by age and diagnosis of a congenital heart defect (clinical cohort).
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
No-intervention
Other interventionObservational cross-sectional study design with no intervention
Treatment groups
4,800 Participants
are divided into 1 treatment groupGroup A: Children and adolescents with congenital heart defects1 intervention
Trial outcomes
Primary outcomes
1
Psychiatric diagnosis
Number of participants fulfilling the ICD-10/DSM-5 criteria for a psychiatric diagnosis based on the DAWBA.
Time frame
Day 12
Emotional and behavioral difficulties
SDQ results will be compared to Danish normative data.
Time frame
Day 1Secondary outcomes
1
Feasibilty
Feasibilty will be evaluated based on participation rate and acceptability of the screening procedure.
Time frame
Day 12
Unmet mental health needs
Mental health service access and unment support needs are evaluated.
Time frame
Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Danish Heart Foundation
Collaborator
The Danish DAWBA Center
Collaborator
Aalborg University Hospital
Collaborator
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov