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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an online psychological program called Tuning in to Kids benefits parents of young children with congenital heart disease. The researchers aim to determine if parents find the program helpful and easy to use, and if it is easy for researchers to deliver. Participants will either join the Tuning in to Kids sessions or continue with usual cardiac care, with an opportunity to try the program later. Parents with children aged 3 to 6 years who have congenital heart disease and receive care at Cincinnati Children’s Heart Institute might be suitable candidates. As an unphased trial, this study offers parents a unique opportunity to contribute to research that could enhance support for similar families.

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.

What prior data suggests that the Tuning in to Kids intervention is safe for parents?

Research has shown that the "Tuning in to Kids" program is safe for parents. It involves online group sessions focused on emotional support and education, with no known physical risks. Past use of this program revealed no harmful effects. The program helps parents manage stress and better understand their children's needs. Participants join online group sessions, which are generally well-received and have not been linked to any safety issues. Overall, the program is considered safe and helpful for parents seeking support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Tuning in to Kids" program because it offers a fresh approach for supporting parents of children with heart disease. Unlike traditional cardiac care, which primarily focuses on the child’s medical needs, this program aims to enhance emotional communication and parenting skills. By equipping parents with tools to better understand and respond to their child's emotional needs, the program potentially improves family dynamics and child well-being, an area often overlooked in standard care. This innovative focus on emotional intelligence and parent-child interaction sets it apart from existing support options, offering a holistic complement to conventional medical treatments.

What evidence suggests that the Tuning in to Kids intervention is effective for parents of children with congenital heart disease?

Research shows that the Tuning in to Kids program, provided to participants in one arm of this trial, may assist parents of children with congenital heart disease. This program aims to enhance communication and emotional understanding between parents and children. Studies have found that parents in similar programs became more aware of emotions and built stronger relationships with their children. These improvements can be particularly beneficial for families dealing with the stress and challenges of congenital heart disease. Although specific data for this group is still being collected, the program has proven effective in similar situations, suggesting a positive impact on the families in this study. ^{1 3 6 7 8}

Who Is on the Research Team?

Nadine A Kasparian, PhD

Principal Investigator

Cincinnati Children's Hospital Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06609707/tuning-in-to-kids-an-online-group-program-tailored-for-parents-of-children-with-congenital-heart-disease

Tuning in to Kids: An Online, Group Program Tailored for ... The goal of this clinical trial is to learn if a virtually-delivered, group-based psychological intervention, called Tuning in to Kids, ...

2. drugtrialsformoney.com drugtrialsformoney.com/tuning-in-to-kids-an-online-group-program-tailored-for-parents-of-children-with-congenital-heart-disease/

Tuning in to Kids: An Online, Group Program Tailored for ... Tuning in to Kids: An Online, Group Program Tailored for Parents of Children With Congenital Heart Disease. Conditions: Heart Defects, ...

3. go.drugbank.com go.drugbank.com/conditions/DBCOND0027858

Heart Defects, Congenital (DBCOND0027858) Tuning in to Kids: An Online, Group Program Tailored for Parents of Children With Congenital Heart Disease, No drug interventions, treatment, Not Available ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5328588/

Academic Outcomes in Children with Congenital Heart ... Children with all types of CHD have poorer academic outcomes compared to their peers. Evaluation for exceptional services should be considered ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.123.010657

Population-Based Estimates of the Prevalence of Children ... Congenital heart defects (CHD) are the most common birth defects and previous estimates report the disease affects 1% of births annually in ...

6. withpower.com withpower.com/trial/phase-parenting-8-2024-4adc7

Online Program for Parents of 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 ...

7. publications.aap.org publications.aap.org/pediatricsopenscience/article/1/2/1/201448/Feasibility-Safety-and-Efficacy-of-Pediatric

Feasibility, Safety, and Efficacy of Pediatric Cardiac ... This randomized controlled trial of pediatric participants with heart disease demonstrated that pediatric cardiac telerehabilitation is feasible ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10712855/

Exploring the use of a digital therapeutic intervention to ... This study explored clinicians' views on the use of a digital therapeutic program to support pediatric heart disease management.