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

Not Applicable

Not yet recruiting

• Conditions: Heart Defects, Congenital; Parenting; Emotion Regulation
• Interventions: Behavioral: Tuning in to Kids

• Registration Number: NCT06609707
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-09-19
• Last Update Submitted: 2024-09-19
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24
• Study Start: 2024-09-30
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tuning in to Kids (Treatment Arm)	Tuning in to Kids	Participants will receive Standard Cardiac Care plus the Tuning in to Kids intervention.

Primary Outcome Measures

Name	Time	Method
Enrollment Rate	Enrollment	≥70% of eligible approached parents enrolled.
Retention Rate	From enrollment to 1-month post intervention period (up to approximately 12 weeks)	≥80% of parents who complete all study procedures.
Proportion of Participants Who Receive All Intervention Content (Fidelity)	From enrollment to 1-month post intervention period (up to approximately 12 weeks)	≥80% of parents who receive all intervention content (intervention group only).
Proportion of Participants with Complete Data (Assessment Completion)	From enrollment to 1-month post intervention period (up to approximately 12 weeks)	≥80% of parents with complete data.
Intervention Acceptability	After Tuning in to Kids Session 3	Treatment Acceptability Scale (TAS) score ≥28 (intervention group only). TAS total scores can range from 7 to 56, with higher scores indicating greater intervention acceptability.
Satisfaction with the Intervention	After Tuning in to Kids Session 6 (at approximately 8 weeks)	Tuning in to Kids Experiences Scale (intervention group only): study-specific measure designed to assess participant satisfaction with the Tuning in to Kids program.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States