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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Defects, Congenital; Mental Health Issue
• Intervention / Treatment: 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.

Our initial plan was to use the SDQ and DAWBA set-up for the entire CHD group, but based on the low participation rates in the first two CHD groups (the Fontans and ASDs) the set-up was simplified.

The set-up we used is as follows:

Set-up for Fontan and Atrial Septal Defects:

Parents and children ≥ 11 years will complete the internet based Strength and Difficulties Questionnaires (SDQ) and the Development and Wellbeing Assessment (DAWBA). The DAWBA data will be rated by trained clinicians for a possible, probably or no specific psychiatric diagnosis. A summarising report of the results from the DAWBA will be provided to the families within 3 months. Parents 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. The feasibility of the entire online screening procedure will be evaluated.

Set-up for other CHD sub-types:

Parents to children and adolescents will complete the internet based Strength and Difficulties Questionnaire (SDQ). Using the predictive algorithms the probabality of any psychiatric disorder is categorised as either possible, probable or unlikely. Unmet mental health needs will be evaluated.

Emotional and behavioral symptoms and unmet mental health needs will be evaluated in different CHD subtypes separately and across subtypes.

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 parents 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 Type: Observational
• Enrollment (Estimated): 4800

Contacts and Locations

• Study Contact: Name: Sara H Lau Jensen, M.D.; Phone Number: 004526192879; Email: sara.hirani.lau-jensen@regionh.dk
• Study Contact Backup: Name: Julie L Hejl, M.D.; Phone Number: 004529895828; Email: julhej@rm.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Department of cardiothoracic surgery, Rigshospitalet
    • Contact: Sara H Lau-Jensen, MD; Phone Number: +4526192879; Email: sara.hirani.lau-jensen@regionh.dk
    • Contact: Vibeke Hjortdal, PhD; Phone Number: +4526192879; Email: vibeke.hjortdal@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The population will be selected though the Danish registries by age and diagnosis of a congenital heart defect (clinical cohort).

Description

Inclusion Criteria:

• Born with a Congenital Heart Defect
• Age 5-17y
• (Living in Denmark)

Exclusion Criteria:

• Younger than 5years of age
• Older than 17years of age
• Lacking sufficient Danish language skills to answer the questionnaire

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Children and adolescents with congenital heart defects; Children and adolescents between 5-17 years of age, born with a congenital heart defect, living in Denmark at the inclusion time. Participants are found though the Danish registries by a diagnosis of congenital heart defect. The diagnosis of Congenital Heart Defect must be given at one of the four University Hospitals in Denmark. These criteria are applied to ensure the validity of the diagnoses. Data will be analysed and grouped based on CHD subgroups and as a whole CHD group.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional and behavioral difficulties	SDQ results will be compared to Danish normative data.	Day 1
Psychiatric diagnosis	Number of participants fulfilling the ICD-10/DSM-5 criteria for a psychiatric diagnosis based on the DAWBA.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibilty	Feasibilty will be evaluated based on participation rate and acceptability of the screening procedure.	Day 1
Unmet mental health needs	Mental health service access and unment support needs are evaluated.	Day 1

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Aarhus University Hospital; Aalborg University Hospital; Danish Heart Foundation; The Danish DAWBA Center
• Investigators: Study Director: Vibeke E Hjortdal, M.D, PhD, professor, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Adolescent; Child; Mental Health; Psychiatry; Heart Defects, Congenital; Questionnaires; Surveys
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Personal Satisfaction; Heart Defects, Congenital; Psychological Well-Being
• Other Study ID Numbers: P-2021-339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared because of the sensitive nature of the data referring to children's psychological profile.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No