Actively Recruiting

Age: 5Years - 17Years
All Genders
Healthy Volunteers
ID05709470

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

Led by Rigshospitalet, Denmark · Updated on 2025-09-26

4800

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

R

Rigshospitalet, Denmark

Lead Sponsor

D

Danish Heart Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying mental health issues in Danish children and adolescents aged 5 to 17 years who were born with congenital heart defects (CHD). This research aims to understand the feasibility of using an online screening model administered by parents and children to identify mental disorders like depression, ADHD, and autism, which are often underdiagnosed in this group. The study also plans to develop a website to provide evidence-based mental health information for families and healthcare providers. Participants are identified from Danish national registries and complete online questionnaires, including the Strength and Difficulties Questionnaire (SDQ) and Development and Wellbeing Assessment (DAWBA) for certain CHD subgroups. Families receive a summary report of results, and feasibility of the online screening is assessed. The study also evaluates emotional and behavioral symptoms and unmet mental health needs across different CHD types. A website will be developed with input from families and health professionals, with user satisfaction measured. During the study, parents and children provide information through questionnaires and interviews. Researchers analyze data on psychiatric diagnoses, emotional and behavioral difficulties, and the practicality of the screening process. Results include unmet mental health needs and user feedback on the website. The study's involvement duration varies, with assessments conducted online. Safety or treatment monitoring is not applicable as this is an observational study without interventions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 5Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Born with a Congenital Heart Defect
  • Age 5-17 years
  • Living in Denmark
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 online questionnaire completion

Monitoring

Duration - Single timepoint on Day 1

Participants complete online questionnaires to evaluate emotional and behavioral symptoms and unmet mental health needs related to congenital heart defects.

1 online questionnaire completion

Trial Site Locations

Total: 1 location

1

Department of cardiothoracic surgery, Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

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Research Team

S

Sara H Lau Jensen, M.D.

J

Julie L Hejl, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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