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

Mental Health Issue Clinical Trial

— Mind the Heart  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709470
• Other study ID #: P-2021-339
• Status: Recruiting
• Start date: March 17, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Rigshospitalet, Denmark
• Contact: Sara H Lau Jensen, M.D.
• Phone: 004526192879
• Email: sara.hirani.lau-jensen[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

A comparison control group of age- and sex-matched heart-healthy children, adolescents and their parents will be included aswell. The control group will be recruitet on a 10:1 basis.

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)).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4800
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• Born with a Congenital Heart Defect

• Age 5-18y

• (Living in Denmark)

Exclusion Criteria:

• Younger than 5years of age

• Older than 18years of age

• Lacking sufficient Danish language skills to answer the questionnaire

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital
• Mental Health Issue

Intervention

Other:
• No-intervention
Observational cross-sectional study design with no intervention

Locations

Country	Name	City	State
Denmark	Department of cardiothoracic surgery, Rigshospitalet	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aalborg University Hospital, Aarhus University Hospital, Danish Heart Foundation, The Danish DAWBA Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with an elevated Total difficulties score from the Strength and Difficulties questionnaire compared to normative data and a matched heart-healthy control group.	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.	One time point.
Primary	Strength and Difficulties Questionnaire Total difficulties score mean/median compared to normative data and a matched heart-healthy control group.	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 both normative data and a matched heart-healthy control group.	Day 1
Secondary	Number of participants with an elevated score in the different subscores from the Strength and Difficulties questionnaire compared to normative data and a matched heart-healthy control group.	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 and a matched heart-healthy control group.	Day 1
Secondary	Strength and Difficulties Questionnaire subscores mean/median compared to normative data and a matched heart-healthy control group.	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 a matched heart-healthy control group has received mental health care.	Day 1
Secondary	DAWBA data	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 and a matched heart-healthy control group.	Day 1
Secondary	Current help data	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).	Day 1