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

Tuning in to Kids: A Virtually-delivered, Group-based, Psychological Intervention for Parents to Improve Emotional and Behavioral Wellbeing Among Children With Congenital Heart Disease

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.

Study Overview

• Status: Completed
• Conditions: Heart Defects, Congenital; Parenting; Emotion Regulation
• Intervention / Treatment: Behavioral: Tuning in to Kids

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: Tuning in to Kids (Treatment Arm); Participants will receive Standard Cardiac Care plus the Tuning in to Kids intervention.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment Rate	≥70% of eligible approached parents enrolled.	Enrollment
Retention Rate	≥80% of parents who complete all study procedures.	From enrollment to 1-month post intervention period (up to approximately 12 weeks)
Proportion of Participants Who Receive All Intervention Content (Fidelity)	≥80% of parents who receive all intervention content (intervention group only).	From enrollment to 1-month post intervention period (up to approximately 12 weeks)
Proportion of Participants with Complete Data (Assessment Completion)	≥80% of parents with complete data.	From enrollment to 1-month post intervention period (up to approximately 12 weeks)
Intervention Acceptability	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.	After Tuning in to Kids Session 3
Satisfaction with the Intervention	Tuning in to Kids Experiences Scale (intervention group only): study-specific measure designed to assess participant satisfaction with the Tuning in to Kids program.	After Tuning in to Kids Session 6 (at approximately 8 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Strengths and Difficulties	Strengths and Difficulties Questionnaire (SDQ): 25-item, validated, widely-used behavioral screening measure with a mix of positive and negatively phrased items assessing five domains (emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, pro-social behavior). Subscale scores are combined (excluding the pro-social scale) into a Total Difficulties score ranging from 0 to 40, with higher scores indicating more problems (with the exception of the pro-social behavior subscale).	From enrollment to 1-month post intervention period (up to approximately 12 weeks)
Parent Difficulties with Emotion Regulation	Difficulties with Emotion Regulation Scale - Short Form (DERS-SF): 18-item, widely-used, validated scale assessing emotional regulation reported by adults (i.e., parents and caregivers) across 6 domains (strategies, non-acceptance, impulse, goals, awareness, clarity). Response options range from 1 ('almost never') to 5 ('almost always'), with total scores ranging from 18 to 90, and higher scores indicating greater difficulties in emotion regulation.	From enrollment to 1-month post intervention period (up to approximately 12 weeks)
Parent Emotional Style	Parent Emotional Style Questionnaire (PESQ): Validated 21-item scale assessing parents' beliefs about their child's emotions, including sadness, anger, and fear.	From enrollment to 1-month post intervention period (up to approximately 12 weeks)
Parent Coping with Children's Negative Emotions	Coping with Children's Negative Emotions Scale (CCNES): 12 scenarios of child negative emotion; parents rate their likelihood of responding in each of six ways.	From enrollment to 1-month post intervention period (up to approximately 12 weeks)

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Nadine A Kasparian, PhD, Cincinnati Children's Hospital Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2024
• Primary Completion (Actual): November 6, 2025
• Study Completion (Actual): November 6, 2025

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Mental Health; Congenital Heart Disease; Randomized Controlled Trial; Psychological Intervention; Parenting; Child Mental Health; Parent Mental Health; Emotion Coaching; Parent-Focused Intervention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Personal Satisfaction; Social Behavior; Self-Control; Heart Defects, Congenital; Psychological Well-Being; Emotional Regulation
• Other Study ID Numbers: 2024-0337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant data that underlie the results reported in the published paper, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 12 months and ending 24 months following publication.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No