The proposed Hybrid Type 1 study is a single-site, two-arm single blinded randomized
clinical trial (RCT) designed to simultaneously assess: 1) efficacy of the stepped care
I-InTERACT-North program in improving positive parenting skills and child behaviour among
families of children with Congenital Heart Disease (CHD) and 2) feasibility and
acceptability outcomes (i.e., adherence, fidelity, costs and acceptability). Our primary
aim is to determine the efficacy of the I-InTERACT-North stepped-care program compared to
care as usual in improving positive parenting skills (primary outcome) and reducing child
emotional and behavioural problems (co-primary outcome) among CHD children. Our secondary
aim is to examine feasibility and acceptability of the stepped-care program among key
stakeholders (parents, therapists, medical providers). Our exploratory aim is to examine
the association between neonatal white matter injury severity on treatment and
implementation outcomes.
The study population will be parents of children currently ages 3 to 9 with histories of
Congenital Heart Disease and are part of existing research cohorts (Cardiovascular
Physiology and Brain Development in Neonates with Congenital Heart Disease; Pediatric
Cardiac and Neurological Registry at SickKids) and have consented to be contacted for
future studies.
I-InTERACT-North is an evidenced-based virtual parenting skills training program, which
emphasizes building a warm, responsive relationship between parent and child and
establishing guidelines for consistent behaviour management. It also provides education
on the effects of medical conditions on children's learning and behaviour. The
stepped-care program provides three steps that sequentially increase therapy content and
degree of therapist involvement, (1) Psychoeducation-Podcast, (2) Intro to Positive
Parenting (2 coaching sessions), and (3) Full Program (5 coaching sessions). Coaching
sessions are offered via videoconference weekly or biweekly based on parent availability.
A care as usual (CAU) was chosen as the optimal comparator given its alignment with the
primary research question, and consistent with prior studies of the program. The CAU
group will receive no direct parent treatment other than clinical care provided in
cardiac follow-up (i.e., child assessment and consultation), which will be documented at
each follow up. At end of trial, the CAU will be offered the program.
All consenting participants will complete baseline questionnaires. Following consent and
completion of baseline measures (therefore hidden allocation), participants will be
randomized by a research coordinator independent of our intervention team. Randomization
will be balanced by 1) child sex assigned at birth, and 2) baseline child behaviour
concern intensity (based on median split grouping; pilot study ECBI median t-score
=60.00). All participants will complete follow-up questionnaires at 3 months, 6 months,
and 12 months post-randomization.