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

Last updated: December 10, 2025
Sponsor: Children's Hospital Medical Center, Cincinnati
Overall Status: Completed

Phase

N/A

Condition

Emotional Processing

Birth Defects

Holoprosencephaly

Treatment

Tuning in to Kids

Clinical Study ID

NCT06609707
2024-0337
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 onecardiology 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 inEnglish.

Exclusion

Exclusion Criteria:

  1. Child has a diagnosed neurodevelopmental disorder (e.g., autism, Trisomy 18), is notspeaking, or is not functioning at the developmental level of a typical 3-year-oldat 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 trainingprogram (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 provideinformed consent.

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

Study Design

Total Participants: 39
Treatment Group(s): 1
Primary Treatment: Tuning in to Kids
Phase:
Study Start date:
September 26, 2024
Estimated Completion Date:
November 06, 2025

Study 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.

Connect with a study center

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Site Not Available

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