Online Program for Parents of Children with Heart Disease

Overseen By Nadine A Kasparian, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Neurodevelopmental disorder, Substance misuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if a virtually-delivered, group-based psychological intervention, called Tuning in to Kids, is feasible and acceptable for parents of children aged 3 to 6 years with congenital heart disease. The main questions this study aims to answer are: * What do parents of children with congenital heart disease think of the Tuning in to Kids intervention? * Is the intervention helpful for parents? * Is the intervention easy for parents to take part in? * Do the researchers find it easy or difficult to deliver the Tuning in to Kids intervention to parents of children with congenital heart disease? Participants will: * Fill out 3 online surveys at home. * Take part in the Tuning in to Kids intervention (which includes six 90-minute, weekly, online group sessions and two booster sessions) or standard cardiac care. * Take part in an interview.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on a psychological intervention for parents, so it's unlikely that medication changes are required.

How does the treatment 'Tuning in to Kids' differ from other treatments for children with heart disease?

The 'Tuning in to Kids' program is unique because it focuses on providing parents with emotional support and education to help them better understand and manage their child's heart condition, rather than directly treating the disease itself. This approach is different from traditional medical treatments, as it emphasizes parental empowerment and coping strategies through an online platform. ^{1 2 3 4 5}

Research Team

Nadine A Kasparian, PhD

Principal Investigator

Cincinnati Children's Hospital Medical Center

Eligibility Criteria

This trial is for parents of children aged 3 to 6 with congenital heart disease. Participants will need to complete online surveys, attend virtual group sessions, and participate in an interview. There's no specific exclusion criteria provided.

Inclusion Criteria

Child is receiving care from the Cincinnati Children's Heart Institute (at least one cardiology visit in the past 12 months)

My child is between 3 and 6 years old.

I or my caregiver can consent and participate in English.

Exclusion Criteria

My child has a neurodevelopmental disorder and cannot speak or act like a typical 3-year-old.

My parent cannot fully understand consent forms due to an intellectual disability.

My child's health or current treatment does not allow participation in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take part in the Tuning in to Kids intervention, which includes six 90-minute, weekly, online group sessions and two booster sessions

8 weeks

6 weekly online group sessions, 2 booster sessions

Follow-up

Participants are monitored for satisfaction, retention, and completion of study procedures

4 weeks

Treatment Details

Interventions

• Tuning in to Kids

Trial Overview The study tests the 'Tuning in to Kids' program delivered online for its feasibility and acceptability among parents. It involves six weekly group sessions, two booster sessions, and compares this intervention against standard cardiac care.

Participant Groups

Group I: Tuning in to Kids (Treatment Arm) Experimental Treatment 1 Intervention

Participants will receive Standard Cardiac Care plus the Tuning in to Kids intervention.

Group II: Standard Cardiac Care Active Control 1 Intervention

Participants assigned to the Standard Cardiac Care group will continue to participate in their child's usual cardiac care and can access any supports available to their child and family. Participants in this group will not take part in the Tuning in to Kids program as part of this study; however, once the study has ended, participants will be offered an opportunity to receive Tuning in to Kids, if they would like to.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Findings from Research

Parents and caregivers of children with heart diseases face significant emotional and social challenges, including lack of support and financial difficulties, which hinder their ability to cope with caregiving demands.

A home-based health care program has been developed to empower these caregivers through multi-component interventions, aiming to improve their coping strategies and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowerment of the rural parents/caregivers of children with heart diseases in Namibia to facilitate coping with the demands of caring at home. Amakali, K., Small, LF.[2021]

References

1. Argentina pubmed.ncbi.nlm.nih.gov

[Educational program for congenital cardiopathy children's parents]. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Identifying gaps in parental support for families of children with hypoplastic left heart syndrome. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Empowerment of the rural parents/caregivers of children with heart diseases in Namibia to facilitate coping with the demands of caring at home. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Acceptability of a parental early warning tool for parents of infants with complex congenital heart disease: a qualitative feasibility study. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Assisting the transition from hospital to home for children with major congenital heart disease by telemedicine: a feasibility study and initial results. [2007]