Stepped-care online parent support following congenital heart disease: Protocol for a randomized control trial (Preprint)

Abstract

Early neurodevelopmental risks, compounded with traumatic medical experiences, contribute to emotional and behavioural 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 behavioural interventions available for CHD children and families. I-InTERACT-North is an online stepped-care mental health program designed to support family well-being and reduce behavioural 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 behaviour problems, with high parent-reported acceptability. The current paper presents the protocol for the first randomized study of stepped-care parent support for families of children with CHD.

This study will involve a single-site, two-arm, single-blind randomized control trial (RCT) to evaluate 1) the feasibility and acceptability of an online stepped-care parent support program (I-InTERACT-North) and 2) the effectiveness of the program in enhancing positive parenting skills and reducing behavioural concerns among families of children with CHD.

Families will be randomized (1:1) to either receive treatment or continue with care as usual (CAU) for 12 months. Randomization will be stratified by child’s sex assigned at birth and baseline parent-reported child behaviour intensity. Primary outcomes include positive parenting skills and child behaviour at baseline, 3 months, 6 months, and 12 months. Secondary outcomes include parental mental health, quality of life, service utilization, and feasibility including program reach and adherence.

A sample size of 244 families will provide >95% power to detect an effect size of d = .64. Based on attrition data from pilot studies, a target of 382 families will be enrolled. Recruitment began in February 2024, and recruitment and follow-up will continue until January 2029. We anticipate results in late 2029.

This study will determine whether online stepped-care parent support is effective in improving positive parenting skills and child behaviour in families of children with CHD. Results will inform future clinical implementation and expansion of this program among families of children with early medical conditions.

NCT06075251