Status:
COMPLETED
Tuning in to Kids: An Online, Group Program Tailored for Parents of Children With Congenital Heart Disease
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Heart Defects, Congenital
Parenting
Eligibility:
All Genders
18+ years
Phase:
NA
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 y...
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. Despit...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2025
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT06609707
Start Date
September 26 2024
End Date
November 6 2025
Last Update
December 12 2025
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229