Online Support 4 CHD Kids & Caregivers

Sponsor
The Hospital for Sick Children
Study ID
NCT06075251
Status
Recruiting
Apply to this trial

Conditions

  • Congenital Heart Disease

Eligibility Criteria

Sex
ALL
Age
3 Years - 9 Years
Healthy Volunteers
Not accepted

Interventions

  • I-InTERACT-North — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Oct 10, 2023
Start date
Feb 15, 2024
Status verified
Apr 2026
Primary completion
Aug 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
382 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

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