Virtual support program for parents of children with congenital heart disease
Stepped-Care Online Parent Support Following Congenital Heart Disease: A Randomized Control Trial
NA · The Hospital for Sick Children · NCT06075251
This study is testing a virtual support program to see if it can help parents of young children with congenital heart disease improve their parenting skills and their child's behavior compared to regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 382 (estimated) |
| Ages | 3 Years to 9 Years |
| Sex | All |
| Sponsor | The Hospital for Sick Children (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06075251 on ClinicalTrials.gov |
What this trial studies
This study evaluates the I-InTERACT-North program, a virtual mental health intervention aimed at improving positive parenting skills and child behavior among families with children aged 3-9 who have congenital heart disease. It is a single-site, two-arm randomized clinical trial that compares the efficacy of this stepped-care program against standard care. The study also assesses the feasibility and acceptability of the program among parents, therapists, and medical providers, aiming to inform future clinical practices. The outcomes will help determine if the program can effectively enhance parenting skills and reduce behavioral issues in children with CHD.
Who should consider this trial
Good fit: Ideal candidates are parents of children aged 3 to 9 years with a history of congenital heart disease who are receiving care at The Hospital for Sick Children.
Not a fit: Patients with significant major medical issues requiring ongoing inpatient care or those currently participating in similar therapy programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve parenting skills and child behavior in families affected by congenital heart disease.
How similar studies have performed: Other studies have shown success with similar virtual parenting interventions, indicating potential for positive outcomes in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- The Hospital for Sick Children — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Tricia S Williams, PhD — The Hospital for Sick Children
- Study coordinator: Tricia S Williams, PhD
- Email: tricia.williams@sickkids.ca
- Phone: 416 813 8507
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Heart Disease