Recruiting

I-InTERACT-North

Sponsor:

The Hospital for Sick Children

Code:

NCT06075251

Conditions

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 3 - 9

Healthy Volunteers: Not accepted

Interventions

I-InTERACT-North

Study Details

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.

Conditions

Congenital Heart Disease

Study ID

NCT06075251

Start date

Feb 15, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Aug 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 9

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

382 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: I-InTERACT-North

Virtual stepped-care positive parenting program.

no intervention: Care as Usual

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, participants randomized to CAU will have the option to participate in I-InTERACT-North.

Interventions

I-InTERACT-North

I-InTERACT-North is a virtual stepped-care positive parenting program. It comprises online psychoeducational modules as well as live therapy and coaching sessions. The program lasts anywhere from 1 to 16 weeks depending on parents' progress.

Primary outcome measure

  • Positive Parenting Skills [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]
  • Child Behaviour [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]

Central Contacts and Locations

Central contacts

Tricia S Williams, PhD

416 813 8507tricia.williams@sickkids.ca

Marin M Taylor

marin.taylor@sickkids.ca

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Principal Investigator:

Tricia Williams, PhD, C.Psych, ABPP

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2026-04-24.