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

NCT06609707 | Completed DMC

• 1 other identifier: 2024-0337
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Defects, Congenital; Parenting; Emotion Regulation

Keywords

Congenital Heart Disease; Mental Health; Parenting; Psychological Intervention; Randomized Controlled Trial; Parent Mental Health; Child Mental Health; Emotion Coaching; Parent-Focused Intervention

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Child Strengths and Difficulties

  From enrollment to 1-month post intervention period (up to approximately 12 weeks)

• Parent Difficulties with Emotion Regulation

  From enrollment to 1-month post intervention period (up to approximately 12 weeks)

• Parent Emotional Style

  From enrollment to 1-month post intervention period (up to approximately 12 weeks)

Study Arms (2)

Standard Cardiac Care

NO 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.

Tuning in to Kids (Treatment Arm)

EXPERIMENTAL

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

Behavioral: Tuning in to Kids

Interventions

Tuning in to Kids 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.

Tuning in to Kids (Treatment Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Child is aged between 3 and 6 years.
• Child is receiving care from the Cincinnati Children's Heart Institute (at least one cardiology visit in the past 12 months).
• Child has congenital heart disease requiring cardiopulmonary bypass during infancy (i.e., by age 12 months).
• Parent or primary caregiver can give consent and participate in the study in English.

You may not qualify if:

• 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.
• Child current medical status or treatment precludes study participation.
• Parent is aged under 18 years.
• Parent is currently participating in another parent-focused or parent training program (e.g., Parent-Child Interaction Therapy).
• Parent suffers from substance misuse or severe, unmanaged mental illness.
• Parent has an intellectual disability impacting capacity to independently provide informed consent.
• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Emotional Regulation; Psychological Well-Being

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Self-Control; Social Behavior; Behavior; Personal Satisfaction

Study Officials

• Nadine A Kasparian, PhD

  Cincinnati Children's Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 24, 2024
• Study Start: September 26, 2024
• Primary Completion: November 6, 2025
• Study Completion: November 6, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 12 months and ending 24 months following publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations

US (1)