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Stepped-Care Web-Based Parent Support Following Congenital Heart Disease: Protocol for a Randomized Controlled Trial
Marin Taylor1, Bianca Christina Bondi1, Brendan F Andrade2,3
1The Department of Psychology, The Hospital for Sick Children, Toronto, ON, Canada.
Insights
This study evaluates I-InTERACT-North, a web-based program to improve parenting skills and reduce behavioral issues in children with congenital heart disease (CHD). Results will guide future support for families facing early medical complexity.
Area of Science:
- Pediatric Psychology
- Developmental Pediatrics
- Digital Health Interventions
Background:
- Children with congenital heart disease (CHD) often experience emotional and behavioral challenges due to early neurodevelopmental risks and medical trauma.
- Existing behavioral interventions for these families are limited, despite a reported need for accessible, evidence-based support.
- I-InTERACT-North is a novel web-based stepped-care program designed to enhance family well-being and positive parenting for children with medical complexity.
Purpose of the Study:
- To evaluate the feasibility and acceptability of the I-InTERACT-North web-based stepped-care parent support program.
- To assess the effectiveness of I-InTERACT-North in improving positive parenting skills and reducing behavioral concerns in families of children with CHD.
- To provide evidence for the clinical implementation and expansion of digital mental health support for medically complex pediatric populations.
Main Methods:
- A single-site, 2-arm, single-blind randomized controlled trial enrolling 382 families of children with CHD.
- Families randomized (1:1) to I-InTERACT-North or usual care for 12 months, stratified by child's sex and baseline behavior intensity.
- Primary outcomes: positive parenting skills and child behavior. Secondary outcomes: parental mental health, quality of life, service usage, feasibility. Analysis via intent-to-treat and generalized estimating equations.
Main Results:
- Recruitment initiated in February 2024, with anticipated results by late 2029.
- The study aims to enroll 382 families, with a target sample size of 244 for >95% power to detect a medium effect size (d=0.64).
- Pilot studies demonstrated high parent-reported acceptability and effectiveness in increasing positive parenting and decreasing child behavior problems.
Conclusions:
- This randomized controlled trial will determine the effectiveness of the I-InTERACT-North program compared to usual care.
- Findings will inform the clinical implementation and scalability of this digital intervention for families of children with CHD and other early medical conditions.
- The study addresses a critical gap in accessible, evidence-based mental health support for vulnerable pediatric populations.
Background:
Early neurodevelopmental risks, compounded with traumatic medical experiences, contribute to emotional and behavioral challenges in as many as 1 in 2 children with congenital heart disease (CHD). Parents report a strong need for supports; yet, there remains a lack of accessible, evidence-based behavioral interventions available for children with CHD and their families. I-InTERACT-North is a web-based stepped-care mental health program designed to support family well-being and reduce behavioral concerns through positive parenting for children with early medical complexity. In previous pilot studies, the program was effective in increasing positive parenting skills and decreasing child behavior problems, with high parent-reported acceptability. This paper presents the protocol for the first randomized study of stepped-care parent support for families of children with CHD.
Objective:
This study will involve a single-site, 2-arm, single-blind randomized controlled trial to evaluate (1) the feasibility and acceptability of a web-based stepped-care parent support program (I-InTERACT-North) and (2) the effectiveness of the program in enhancing positive parenting skills and reducing behavioral concerns among families of children with CHD.
Methods:
Families will be randomized (1:1) to either receive treatment or continue with care as usual for 12 months. Randomization will be stratified by child's sex assigned at birth and baseline parent-reported child behavior intensity. Primary outcomes include positive parenting skills and child behavior at baseline, 3 months, 6 months, and 12 months. Secondary outcomes include parental mental health, quality of life, service usage, and feasibility including program reach and adherence. A sample size of 244 families will provide >95% power to detect an effect size of d=0.64. Based on attrition data from pilot studies, a target of 382 families will be enrolled. Parent reports of acceptability, adoption, and suggested adaptability of the program will be examined using cross-case thematic analyses. Primary efficacy analysis will be conducted using an intent-to-treat approach. Generalized estimating equations will be used to examine changes in positive parenting. Child behavior, quality of life, and parent mental health will be tested with repeated-measures analyses. Additional sensitivity and replication analyses will also be carried out.
Results:
Recruitment began in February 2024, and recruitment and follow-up will continue until January 2029. We anticipate results in late 2029.
Conclusions:
This study aims to test the effectiveness of I-InTERACT-North web-based stepped-care parent support in improving positive parenting skills and reducing child behavior problems in families of children with CHD compared with a care as usual control group. Results will inform future clinical implementation and expansion of this program among families of children with early medical conditions.
Trial Registration:
ClinicalTrials.gov NCT06075251; https://clinicaltrials.gov/study/NCT06075251.
International Registered Report Identifier (Irrid):
DERR1-10.2196/64216.
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