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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
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
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Copenhagen, Denmark, 2100
- Recruiting
- Department of cardiothoracic surgery, Rigshospitalet
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Contact:
- Sara H Lau-Jensen, MD
- Phone Number: +4526192879
- Email: sara.hirani.lau-jensen@regionh.dk
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Contact:
- Vibeke Hjortdal, PhD
- Phone Number: +4526192879
- Email: vibeke.hjortdal@regionh.dk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
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. |
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
Time Frame: Day 1
|
SDQ results will be compared to Danish normative data.
|
Day 1
|
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Psychiatric diagnosis
Time Frame: Day 1
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Number of participants fulfilling the ICD-10/DSM-5 criteria for a psychiatric diagnosis based on the DAWBA.
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Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibilty
Time Frame: Day 1
|
Feasibilty will be evaluated based on participation rate and acceptability of the screening procedure.
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Day 1
|
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Unmet mental health needs
Time Frame: Day 1
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Mental health service access and unment support needs are evaluated.
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Day 1
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Vibeke E Hjortdal, M.D, PhD, professor, University of Copenhagen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-2021-339
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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