MedTrace Logo

Feasibility of a Virtual Mental Health Intervention for Children with Congenital Heart Disease

NCT06659302 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-10-26

No results posted yet for this study

Summary

Children with congenital heart disease are at much higher risk for behavioral and emotional difficulties in early childhood and beyond 1. However, intervention programs aimed at this population are limited and few have explored the efficacy of behavioral parent training on child behavior and parent stress in children with CHD. Few evidence-based behavior intervention programs are available in the community for families of children with CHD and behavioral struggles and many families struggle to stick with long-term treatment given the multiple appointments and responsibilities that are often already associated in parenting children with chronic health conditions. As such, more targeted, shorter and more accessible interventions are very needed. Established internet-based treatments such as I-InTERACT-North, are particularly well-suited for adaptation to stepped-care delivery due to prior implementation success, readily adaptable intensity of online content and therapist contact.

This study will evaluate whether I-InTERACT North is a feasible intervention to implement in a step-care model and whether it is acceptable to families and impacts behavior and family functioning.

Conditions

  • Congenital Heart Disease (CHD)

Interventions

BEHAVIORAL

I-inTERACT North Step 1

Initial questionnaires completed followed by initial meeting with therapist for baseline evaluation.

BEHAVIORAL

I-inTERACT North step 2

Two online modules completed by family plus two online zoom coaching sessions with therapist.

BEHAVIORAL

I-inTERACT North

Full program will consist of an additional 5 sessions with online modules and virtual coaching sessions with therapist.

Sponsors & Collaborators

  • The Hospital for Sick Children

    collaborator OTHER

  • Alberta Children's Hospital

    collaborator OTHER

  • University of Calgary

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-15
Primary Completion
2025-12-31
Completion
2025-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06659302 on ClinicalTrials.gov