Application of Theory and Evidence to Promote Full Recovery From Pediatric Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Feasibility of the Cellie Coping Kit Intervention
研究概览
简要总结
The purpose of this study is to assess the feasibility (fidelity, acceptability, implementation, cost) of the Cellie Coping Kit for Children with Injury as well as to determine the intervention's efficacy (mechanisms of action and health outcomes).
详细描述
The goal of this study is to assess the Cellie Coping Kit for Injury intervention feasibility and initial efficacy.
Aim 1: Intervention Feasibility Assess intervention feasibility (implementation, cost, fidelity).
Aim 2: Intervention Efficacy (Mechanisms of Action and Health Outcomes): Conduct initial efficacy evaluation of the Cellie Intervention on mechanisms of action (adherence and coping behaviors) and health outcomes (physical recovery, HRQOL, emotional health).
Hypotheses: At 6-week follow-up (T2), compared to a Treatment as Usual (TAU) control group, parents in the intervention group will report greater adherence to medical discharge instructions (H2.1) and encourage their child to use a higher number of adaptive coping strategies (cognitive, active, support seeking; H2.2); children in the intervention group will generate a greater number of adaptive coping strategies (H2.3).
Hypotheses: At a 12-week follow-up (T3), compared to TAU, children in the intervention group will report better HRQOL and emotional health (H2.4); parents in the intervention group will report better child HRQOL and child emotional health (H2.5). Objective injury recovery scores will be higher for the intervention group (H2.6).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child has incurred an injury within the last month requiring medical attention
- •one caregiver per child willing to participate
- •sufficient English language skills to understand intervention and assessment materials
- •access to internet or telephone for follow-up assessments
排除标准
- •injury resulting from family violence
研究组 & 干预措施
Cellie Intervention
The Cellie Coping Kit intervention is grounded in empirical evidence regarding injury recovery. By utilizing parents as coaches, the Cellie Coping intervention can be initiated in the hospital and continued as the child recovers at home. The intervention's portable, engaging design and active partnership with parents as consistently available coaches, allows families to use the intervention anywhere (i.e., home, hospital, during procedures) ensuring the child is supported at the time the injury-related stressor arises. The Cellie Coping Intervention consists of 1) a stuffed toy to promote engagement, 2) caregiver book, and 3) coping cards. Skills are presented in a way usable by most parents and children without medical team support. In this condition, children and parents will be introduced to the Cellie Intervention immediately following the completion of the T1 measures.
干预措施: Cellie Coping Kit Intervention (Behavioral)
Cellie Wait-list Control
The Cellie Coping Kit intervention is grounded in empirical evidence regarding injury recovery. By utilizing parents as coaches, the Cellie Coping intervention can be initiated in the hospital and continued as the child recovers at home. The intervention's portable, engaging design and active partnership with parents as consistently available coaches, allows families to use the intervention anywhere (i.e., home, hospital, during procedures) ensuring the child is supported at the time the injury-related stressor arises. The Cellie Coping Intervention consists of 1) a stuffed toy to promote engagement, 2) caregiver book, and 3) coping cards. Skills are presented in a way usable by most parents and children without medical team support. In this condition, children and parents will be introduced to the Cellie Intervention via phone and mail following the completion of the T3 measures.
干预措施: Cellie Coping Kit Intervention (Behavioral)
结局指标
主要结局
Feasibility of the Cellie Coping Kit Intervention
时间窗: 6 weeks
Feasibility will be primarily assessed via a self-report satisfaction score.
次要结局
- Initial assessment of efficacy of Cellie Intervention on adherence(6 weeks)
- Initial assessment of efficacy of Cellie Intervention on coping behaviors(6 weeks)
- Initial assessment of efficacy of Cellie Intervention on physical recovery(12 weeks)
- Initial assessment of efficacy of Cellie Intervention on HRQOL(12 weeks)
- Initial assessment of efficacy of Cellie Intervention on emotional health(12 weeks)
研究者
Meghan Marsac
Assistant Professor
University of Kentucky