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Behavioral Intervention

I-InTERACT-North for Congenital Heart Disease

N/A

Recruiting

Led By Tricia S Williams, PhD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, and 12 months

Awards & highlights

Study Summary

This trial will assess a virtual mental health parenting program (I-InTERACT-North) to see if it helps improve positive parenting skills and child behavior in families with children born with Congenital Heart

Who is the study for?

This trial is for parents of children aged 3-9 with congenital heart disease (CHD) who are patients at SickKids Hospital in Ontario, Canada. It aims to help these families by improving parenting skills and child behavior.Check my eligibility

What is being tested?

The I-InTERACT-North program, a virtual mental health intervention for parents, is being tested to see if it can enhance positive parenting and improve child behavior among CHD affected families.See study design

What are the potential side effects?

Since this is a mental health and skill development program rather than a medical treatment, traditional physical side effects are not expected; however, participants may experience emotional or psychological responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Child Behaviour

Positive Parenting Skills

Secondary outcome measures

Parent Mental Health

Quality of Life

Service Utilisation

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: I-InTERACT-NorthExperimental Treatment1 Intervention

Virtual stepped-care positive parenting program.

Group II: Care as UsualActive Control1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

691 Previous Clinical Trials

6,945,232 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,132 Total Patients Enrolled

Tricia S Williams, PhDPrincipal InvestigatorThe Hospital for Sick Children

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there ongoing efforts to recruit patients for participation in this clinical trial?

"As per the information available on clinicaltrials.gov, this medical research study is actively seeking eligible participants. The trial was initially listed on 15th February 2024 and most recently revised on 15th April 2024."

Answered by AI

What is the current number of participants being enlisted for this clinical trial?

"Indeed, as per the details on clinicaltrials.gov, this trial is actively seeking subjects. The initial posting of the study was on February 15th, 2024 and its latest update was on April 15th, 2024. To complete the trial successfully, recruitment of 382 patients from a single location is essential."

Answered by AI

Does the study include participants who are older than 85 years of age?

"Patients eligible for this trial must be between 3 and 9 years old. Among the registered trials, there are 96 studies focused on individuals under 18 years of age and 259 centered around those above 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Online Support 4 CHD Kids & Caregivers

Tricia Williams 2024. "Online Support 4 CHD Kids & Caregivers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06075251.