Clinical trial NCT05709470: Mind the Heart, Online Screening of the Mental Health in Children and Adolescents With Congenital Heart Defects
Official title: Mind the Heart - Mental Health in Children and Adolescents With Congenital Heart Defects in Denmark
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Defects, Congenital
Mental Health Issue
Keywords: Heart Defects, Congenital
Mental Health
Child
Adolescent
Surveys
Questionnaires
Psychiatry
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Heart Foundation
name: The Danish DAWBA Center
name: Aalborg University Hospital
name: Aarhus University Hospital
First posted: 2023-02-02
Enrollment: 4800
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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).

The control group will be selected thought the Danish registries to match the clinical population, but with no history of CHD.

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.

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. Parents and children ≥ 11 years will further complete the internet based Strengths and Difficulties Questionnaire (SDQ) and Development and Wellbeing Assessment (DAWBA). Based on their answers, the SDQ and DAWBA automatically calculates the likelihood that the child or adolescent meets diagnostic criteria for one or more psychiatric diagnoses. In order to increase validity of the diagnoses, the SDQ and DAWBA data will subsequently be rated by trained clinicians, and a summarising report of the results will be provided for the families within 3 months. Parents and children ≥ 11 years 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.

A comparison control group of age- and sex-matched heart-healthy children, adolescents and their parents will be included aswell. The control group will be recruitet on a 10:1 basis.

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 parent 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)).

Eligibility criteria: Inclusion Criteria:

* Born with a Congenital Heart Defect
* Age 5-18y
* (Living in Denmark)

Exclusion Criteria:

* Younger than 5years of age
* Older than 18years of age
* Lacking sufficient Danish language skills to answer the questionnaire

Primary outcomes:
measure: Number of participants with an elevated Total difficulties score from the Strength and Difficulties questionnaire compared to normative data and a matched heart-healthy control group.
timeFrame: One time point.
measure: Strength and Difficulties Questionnaire Total difficulties score mean/median compared to normative data and a matched heart-healthy control group.
timeFrame: Day 1
Secondary outcomes:
measure: Number of participants with an elevated score in the different subscores from the Strength and Difficulties questionnaire compared to normative data and a matched heart-healthy control group.
timeFrame: Day 1
measure: Strength and Difficulties Questionnaire subscores mean/median compared to normative data and a matched heart-healthy control group.
timeFrame: Day 1
measure: DAWBA data
timeFrame: Day 1
measure: Current help data
timeFrame: Day 1
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of cardiothoracic surgery, Rigshospitalet
Study officials:
affiliation: University of Copenhagen
name: Vibeke E Hjortdal, M.D, PhD, professor
role: STUDY_DIRECTOR
References: