Trial Summary
What is the purpose of this trial?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
This trial is for parents of children aged 3 to 6 with congenital heart disease. Participants will need to complete online surveys, attend virtual group sessions, and participate in an interview. There's no specific exclusion criteria provided.Inclusion Criteria
Child is receiving care from the Cincinnati Children's Heart Institute (at least one cardiology visit in the past 12 months)
My child is between 3 and 6 years old.
I or my caregiver can consent and participate in English.
+1 more
Exclusion Criteria
My child has a neurodevelopmental disorder and cannot speak or act like a typical 3-year-old.
My parent cannot fully understand consent forms due to an intellectual disability.
My child's health or current treatment does not allow participation in the study.
+4 more
Participant Groups
The study tests the 'Tuning in to Kids' program delivered online for its feasibility and acceptability among parents. It involves six weekly group sessions, two booster sessions, and compares this intervention against standard cardiac care.
2Treatment groups
Experimental Treatment
Active Control
Group I: Tuning in to Kids (Treatment Arm)Experimental Treatment1 Intervention
Participants will receive Standard Cardiac Care plus the Tuning in to Kids intervention.
Group II: Standard Cardiac CareActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cincinnati Children's Hospital Medical CenterCincinnati, OH
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Who Is Running the Clinical Trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor