Mind the Heart, Online Screening of the Mental Health in Children and Adolescents With Congenital Heart Defects

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05709470

Collaborator

Danish Heart Foundation (Other), The Danish DAWBA Center (Other), Aalborg University Hospital (Other), Aarhus University Hospital (Other)

4,800

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Defects, Congenital Mental Health Issue	Other: No-intervention

Detailed Description

Background:

CHD affects approximately 6-10 children per 1000 live births. Innovations in somatic treatment during the last 50 years have increased survival in children with CHD, but also showed a higher risk of cognitive disabilities and MDs like depression, ADHD and autism in children and adolescents with CHD compared to the general population. Untreated childhood MDs may have serious implications for the child's social and academic functioning, quality of life, future health and employment.

Methods:

Danish children and adolescents diagnosed with CHD (N ~ 4800) will be identified through Danish national registries. Parents to eligible children and adolescents will complete bespoke online questionnaires on sociodemographic factors and received psychological support for their children. Parents and children ≥ 11 years will further complete the internet based Strengths and Difficulties Questionnaire (SDQ) and Development and Wellbeing Assessment (DAWBA). Based on their answers, the SDQ and DAWBA automatically calculates the likelihood that the child or adolescent meets diagnostic criteria for one or more psychiatric diagnoses. In order to increase validity of the diagnoses, the SDQ and DAWBA data will subsequently be rated by trained clinicians, and a summarising report of the results will be provided for the families within 3 months. Parents and children ≥ 11 years will be asked to complete a feasibility questionnaire on the screening procedure, including if they think it would be beneficial to adopt such a procedure in typical clinical practice.

In collaboration with families and cross-sectoral health care providers, a website will be developed. User needs will be identified through semi-structured interviews with representative end users, and the written content will be developed based on a systematic review of the scientific literature, including systematic reviews and meta-analysis, that either illuminates aetiological and maintaining factors for MDs in children and adolescents with CHD, or describes and tests various interventions, and a review of existing information material and management guidelines. The website will be hosted at Rigshospitalet. End user satisfaction will be evaluated through a bespoke questionnaire combined with the System Usability Scale.

The semi-structured interviews with the parent to children and adolescents with CHD and concurrent MDs will further be used for a qualitative study to explore their lived experiences of these issues (Linking Heart and Mind, described elsewhere (https://osf.io/93nb6)).

Study Design

Study Type:

Observational

Anticipated Enrollment :

4800 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Mind the Heart - Mental Health in Children and Adolescents With Congenital Heart Defects in Denmark

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Children and adolescents with congenital heart defects Children and adolescent between 5-18 years of age, born with a congenital heart defect, living in Denmark at the inclusion time. A parent to each child/adolescent should also participate. Participants are found though the Danish registries by a diagnosis of congenital heart defect. The diagnosis of Congenital Heart Defect most be giving at one of the four University Hospitals in Denmark. These criteria were applied to ensure the validity of the diagnoses.	Other: No-intervention Observational cross-sectional study design with no intervention

Arm

Intervention/Treatment

Children and adolescents with congenital heart defects

Children and adolescent between 5-18 years of age, born with a congenital heart defect, living in Denmark at the inclusion time. A parent to each child/adolescent should also participate. Participants are found though the Danish registries by a diagnosis of congenital heart defect. The diagnosis of Congenital Heart Defect most be giving at one of the four University Hospitals in Denmark. These criteria were applied to ensure the validity of the diagnoses.

Other: No-intervention

Observational cross-sectional study design with no intervention

Outcome Measures

Primary Outcome Measures

Number of participants with an elevated Total difficulties score from the Strength and Difficulties questionnaire compared to normative data. [One time point.]
Total difficulties score (elevated results above the 80th percentile) of the Strength and Difficulties Questionnaire (SDQ) between the study group (children and adolescents with congenital heart defects) and normative data.
Strength and Difficulties Questionnaire Total difficulties score mean/median compared to normative data. [Day 1]
Total difficulties score (mean or median) of the Strength and Difficulties Questionnaire (SDQ) between the study group (children and adolescents with congenital heart defects) and normative data.

Secondary Outcome Measures

Number of participants with an elevated score in the different subscores from the Strength and Difficulties questionnaire compared to normative data. [Day 1]
The subscores (Emotional problem score, Conduct problem score, Hyperactivity score, Peer problems score, Prosocial score) (numbers of elevated results above the 80th percentile) and the Impact score of the Strength and Difficulties Questionnaire (SDQ) between the study group (children and adolescents with congenital heart defects) and normative data.
Strength and Difficulties Questionnaire subscores mean/median compared to normative data. [Day 1]
The subscores (Emotional problem score, Conduct problem score, Hyperactivity score, Peer problems score, Prosocial score) (mean or median) and the Impact score of the Strength and Difficulties Questionnaire (SDQ) between the study group (children and adolescents with congenital heart defects) and normative data and DAWBA data) has received mental health care.
DAWBA data [Day 1]
Number of Participants with am ICD-10 or DMS-V diagnosis of a major psychiatric disorder (eg. pervasive developmental disorders, hyperkinetic disorder, oppositional defiant disorder, conduct disorders, anxiety disorders, depressive disorders, obsessive-compulsive disorders) compared to the background Danish children and adolescent population.
Current help data [Day 1]
Number of participants that though a feasibility questionnaire (developed by us) evaluated the screening process feasible (scores individual and as a total above 8 on a 10 step likert- scale).