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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
39
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.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Enrollment Rate
≥70% of eligible approached parents enrolled.
Time frame: Enrollment
Retention Rate
≥80% of parents who complete all study procedures.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After Tuning in to Kids Session 6 (at approximately 8 weeks)
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