Online Support 4 CHD Kids & Caregivers

NCT06075251 | Recruiting

• 1 other identifier: 1000080752
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Positive Parenting Skills

  The primary proximal outcome will be positive parenting skills assessed through blinded (to allocation and follow up interval) coding of recorded parent-child interactions, using the Dyadic Parent-Child Interaction Coding System (DPICS). The DPICS will be used to rate positive parenting behaviors (e.g. praise, responsiveness, and enthusiasm). The DPICS is analyzed by independent blinded coders (to condition and time) observe and code parent-child interactions (5 minutes) for positive parenting behaviours (e.g., praise, responsiveness and enthusiasm).

  Baseline, 3 months, 6 months, and 12 months

• Child Behaviour

  The Eyberg Child Behavior Inventory (ECBI), is a parent rated 36-item checklist of concerns (e.g., noncompliance, emotional regulation).

  Baseline, 3 months, 6 months, and 12 months

Secondary Outcomes (3)

• Quality of Life

  Baseline, 3 months, 6 months, and 12 months

• Parent Mental Health

  Baseline, 3 months, 6 months, and 12 months

• Service Utilisation

  Baseline, 3 months, 6 months, and 12 months

Study Arms (2)

I-InTERACT-North

EXPERIMENTAL

Virtual stepped-care positive parenting program.

Behavioral: I-InTERACT-North

Care as Usual

NO INTERVENTION

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 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.

I-InTERACT-North

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Related Publications (1)

• Taylor M, Bondi BC, Andrade BF, Au-Young SH, Chau V, Danguecan A, Desire N, Guo T, Ostojic-Aitkens D, Wade S, Miller S, Williams TS. Stepped-Care Web-Based Parent Support Following Congenital Heart Disease: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 4;13:e64216. doi: 10.2196/64216.

  PMID: 39365658 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Tricia S Williams, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tricia S Williams, PhD

CONTACT

416 813 8507; tricia.williams@sickkids.ca

Marin M Taylor

CONTACT

marin.taylor@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors responsible for coding the primary outcome will be masked to condition. Due to the nature of the intervention (behavioural program), participants and care providers cannot be masked to condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: February 15, 2024
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)