Heart Defects, CongenitalMind the HeartNCT05709470
Mind the Heart - Mental Health in Children and Adolescents With Congenital Heart Defects
An observational study of Heart Defects, Congenital and Mental Health Issue, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Defects, Congenital, Mental Health Issue
- What is being tested?
- No-intervention
- How many people
- 4,800 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Mar 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The population will be selected though the Danish registries by age and diagnosis of a congenital heart defect (clinical cohort).
Who may be able to join
- Born with a Congenital Heart Defect
- Age 5-17y
- (Living in Denmark)
Who cannot join
- Younger than 5years of age
- Older than 17years of age
- Lacking sufficient Danish language skills to answer the questionnaire
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of cardiothoracic surgery, Rigshospitalet
Copenhagen, 2100
Sara H Lau-Jensen, MD, +4526192879, sara.hirani.lau-jensen@regionh.dk
Vibeke Hjortdal, PhD, +4526192879, vibeke.hjortdal@regionh.dk
About this study
Official title: 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.
Read the 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)).
- Conditions
- Heart Defects, Congenital, Mental Health Issue
- Being tested
- No-intervention
- Keywords
- Heart Defects, Congenital, Mental Health, Child, Adolescent, Surveys, Questionnaires, Psychiatry
- Medical subject headings
- Heart Defects, Congenital, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No-interventionOther
Observational cross-sectional study design with no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric diagnosis
Number of participants fulfilling the ICD-10/DSM-5 criteria for a psychiatric diagnosis based on the DAWBA.
Measured: Day 1
Emotional and behavioral difficulties
SDQ results will be compared to Danish normative data.
Measured: Day 1
Secondary outcomes (2)
Feasibilty
Feasibilty will be evaluated based on participation rate and acceptability of the screening procedure.
Measured: Day 1
Unmet mental health needs
Mental health service access and unment support needs are evaluated.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start17 Mar 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 4,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation, The Danish DAWBA Center, Aalborg University Hospital, Aarhus University Hospital
- Responsible party
- Principal investigator, Sara Hirani Lau-Jensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Vibeke E Hjortdal, M.D, PhD, professor, Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709470
- Sponsor's protocol ID
- P-2021-339
- Acronym
- Mind the Heart
- Status last verified
- Sep 2025
- First submitted
- 11 Jan 2023
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because of the sensitive nature of the data referring to children's psychological profile.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind the Heart - Mental Health in Children and Adolescents With Congenital Heart Defects in Denmark
- ClinicalTrials.gov ID
- NCT05709470
- Acronym / sponsor ID
- Mind the Heart / P-2021-339
- Conditions
- Heart Defects, Congenital, Mental Health Issue
- Keywords
- Heart Defects, Congenital, Mental Health, Child, Adolescent, Surveys, Questionnaires, Psychiatry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,800 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Heart Foundation, The Danish DAWBA Center, Aalborg University Hospital, Aarhus University Hospital
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and adolescents with congenital heart defects | – | Other: No-interventionChildren 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The population will be selected though the Danish registries by age and diagnosis of a congenital heart defect (clinical cohort).
Key inclusion criteria (3 listed)
- Born with a Congenital Heart Defect
- Age 5-17y
- (Living in Denmark)
Key exclusion criteria (3 listed)
- Younger than 5years of age
- Older than 17years of age
- Lacking sufficient Danish language skills to answer the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No-interventionObservational cross-sectional study design with no intervention | Other | Children and adolescents with congenital heart defects |
Primary outcome
Psychiatric diagnosis
Time frame: Day 1
Number of participants fulfilling the ICD-10/DSM-5 criteria for a psychiatric diagnosis based on the DAWBA.
Emotional and behavioral difficulties
Time frame: Day 1
SDQ results will be compared to Danish normative data.
2 secondary outcomes
Feasibilty
Time frame: Day 1
Unmet mental health needs
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No. IPD will not be shared because of the sensitive nature of the data referring to children's psychological profile.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vibeke E Hjortdal, M.D, PhD, professor study director
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Defects, Congenital and Mental Health Issue, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara H Lau Jensen, M.D. (004526192879, sara.hirani.lau-jensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychiatric diagnosis (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.