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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Enrollment Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Enrollment Rate
时间窗: Enrollment
≥70% of eligible approached parents enrolled.
Retention Rate
时间窗: From enrollment to 1-month post intervention period (up to approximately 12 weeks)
≥80% of parents who complete all study procedures.
Proportion of Participants Who Receive All Intervention Content (Fidelity)
时间窗: From enrollment to 1-month post intervention period (up to approximately 12 weeks)
≥80% of parents who receive all intervention content (intervention group only).
Proportion of Participants with Complete Data (Assessment Completion)
时间窗: From enrollment to 1-month post intervention period (up to approximately 12 weeks)
≥80% of parents with complete data.
Intervention Acceptability
时间窗: After Tuning in to Kids Session 3
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.
Satisfaction with the Intervention
时间窗: After Tuning in to Kids Session 6 (at approximately 8 weeks)
Tuning in to Kids Experiences Scale (intervention group only): study-specific measure designed to assess participant satisfaction with the Tuning in to Kids program.
次要结局
未报告次要终点
研究者
Nadine Kasparian
Professor
Children's Hospital Medical Center, Cincinnati