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

NCT05709470 | Recruiting

• 1 other identifier: P-2021-339
• Study Type: observational
• Target: 4,800
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Defects, Congenital; Mental Health Issue

Keywords

Heart Defects, Congenital; Mental Health; Child; Adolescent; Surveys; Questionnaires; Psychiatry

Outcome Measures

Primary Outcomes (2)

• Psychiatric diagnosis

  Number of participants fulfilling the ICD-10/DSM-5 criteria for a psychiatric diagnosis based on the DAWBA.

  Day 1

• Emotional and behavioral difficulties

  SDQ results will be compared to Danish normative data.

  Day 1

Secondary Outcomes (2)

• Feasibilty

  Day 1

• Unmet mental health needs

  Day 1

Study Arms (1)

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

Interventions

No-intervention OTHER

Observational cross-sectional study design with no intervention

Children and adolescents with congenital heart defects

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Heart Foundation: collaborator
• The Danish DAWBA Center: collaborator
• Aalborg University Hospital: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of cardiothoracic surgery, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Psychological Well-Being

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Personal Satisfaction; Behavior

Study Officials

• Vibeke E Hjortdal, M.D, PhD, professor

  University of Copenhagen

  STUDY DIRECTOR

Central Study Contacts

Sara H Lau Jensen, M.D.

CONTACT

004526192879; sara.hirani.lau-jensen@regionh.dk

Julie L Hejl, M.D.

CONTACT

004529895828; julhej@rm.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigater

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 2, 2023
• Study Start: March 17, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)