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

NCT ID: NCT06609707

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-26
• Study Completion Date: 2025-11-06

Brief Summary

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.

Detailed Description

Mental health conditions are common among children with congenital heart disease (CHD) and are strongly associated with cardiovascular morbidity and mortality, as well as lower quality of life. Despite increasing awareness, the mental health needs of children with CHD remain largely unmet, especially among those from historically marginalized and underserved communities. To address this gap, this study will test, for the first time in CHD, a virtually-delivered, group-based psychological intervention, called Tuning in to Kids, designed to teach parents how to help their children understand, regulate, and manage their emotions. The intervention includes six, 90-minute, weekly, online group sessions and two 'booster' sessions, coupled with educational resources and home practice activities to improve parent-child interactions, and enhance child emotional and behavioral functioning. Each group is facilitated by two qualified health professionals who are trained in, and certified to deliver, the Tuning in to Kids intervention. In this pilot randomized controlled trial, we will enroll 40 parents (or other primary caregivers) of children aged 3 or 6 years with CHD who underwent surgical intervention in infancy. The primary aim of this study is to assess intervention acceptability and feasibility, and the results generated will directly inform the design of, and provide preliminary data for, a multicenter efficacy trial to examine short- and longer-term intervention effects.

Conditions

Heart Defects, Congenital; Parenting; Emotion Regulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Cardiac Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Tuning in to Kids (Treatment Arm)

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

Group Type: EXPERIMENTAL

Tuning in to Kids

Intervention Type: BEHAVIORAL

Tuning in to Kids is an evidence-based, emotion-focused, group parenting program designed to teach caregivers skills in recognizing, understanding, and managing their own and their children's emotions. The program includes six 90-minute, weekly, online group sessions and two optional 'booster' sessions to consolidate skills. Parents are taught five steps of emotion coaching and participate in exercises sequentially targeting each step. Intervention components include psychoeducation, emotion coaching demonstrations, role plays, group discussion, written resources, and home practice exercises. The program teaches parents skills in emotion coaching as a way of responding to their child's emotions. These skills help children to understand and regulate their emotions. As per the Tuning in to Kids manual, two trained, licensed health professionals will co-facilitate each group.

Interventions

Tuning in to Kids

Tuning in to Kids is an evidence-based, emotion-focused, group parenting program designed to teach caregivers skills in recognizing, understanding, and managing their own and their children's emotions. The program includes six 90-minute, weekly, online group sessions and two optional 'booster' sessions to consolidate skills. Parents are taught five steps of emotion coaching and participate in exercises sequentially targeting each step. Intervention components include psychoeducation, emotion coaching demonstrations, role plays, group discussion, written resources, and home practice exercises. The program teaches parents skills in emotion coaching as a way of responding to their child's emotions. These skills help children to understand and regulate their emotions. As per the Tuning in to Kids manual, two trained, licensed health professionals will co-facilitate each group.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Child is aged between 3 and 6 years.

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

3. Child has congenital heart disease requiring cardiopulmonary bypass during infancy (i.e., by age 12 months).

4. Parent or primary caregiver can give consent and participate in the study in English.

Exclusion Criteria

1. Child has a diagnosed neurodevelopmental disorder (e.g., autism, Trisomy 18), is not speaking, or is not functioning at the developmental level of a typical 3-year-old at the time of study recruitment.

2. Child current medical status or treatment precludes study participation.

3. Parent is aged under 18 years.

4. Parent is currently participating in another parent-focused or parent training program (e.g., Parent-Child Interaction Therapy).

5. Parent suffers from substance misuse or severe, unmanaged mental illness.

6. Parent has an intellectual disability impacting capacity to independently provide informed consent.

7. The child's treating physician or the study interventionalist identifies the parent or child as having a condition or circumstance that is contraindicative to engagement with the Tuning in to Kids program.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Nadine Kasparian

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadine A Kasparian, PhD

Role: PRINCIPAL_INVESTIGATOR

Cincinnati Children's Hospital Medical Center

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2024-0337

Identifier Type: -

Identifier Source: org_study_id