Clinical trial NCT06075251: Online Support 4 CHD Kids & Caregivers
Official title: Stepped-Care Online Parent Support Following Congenital Heart Disease: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-10-10
Enrollment: 382
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a single-site, two-arm randomized clinical trial. Families will be randomized to receive care as usual or active I-InTERACT-North stepped-care treatment.
Primary purpose: TREATMENT

Brief summary: This study will evaluate a virtual mental health parenting stepped-care intervention (I-InTERACT-North) to determine if the program works to improve positive parenting skills and child behaviour among families with children born with Congenital Heart Disease (CHD). Recruitment will target children ages 3-9 years old from SickKids. We will also evaluate the acceptability and feasibility of the program among children and families to inform future delivery and multi-site trials. Results will evaluate whether I-InTERACT-North can improve parenting and child behaviour in these families and inform future best clinical practices for this population.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Parent of a child aged 3 to 9 years with history of congenital heart disease
* Parent of a patient at The Hospital for Sick Children (SickKids)
* Resident of Ontario, Canada

Exclusion Criteria:

* Significant major medical issues requiring ongoing inpatient care (e.g., children participating in significant surgical or inpatient treatment)
* Current participation in an equivalent family/parent therapy program (e.g., Incredible Years Parenting Program (IYPP), Positive Parenting Program (Triple P))
* Previous participation in an I-InTERACT-North pilot study

Primary outcomes:
measure: Positive Parenting Skills
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Child Behaviour
timeFrame: Baseline, 3 months, 6 months, and 12 months
Secondary outcomes:
measure: Quality of Life
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Parent Mental Health
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Service Utilisation
timeFrame: Baseline, 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Tricia S Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References: