A Randomized Controlled Trial of "Coping Coach," a Web-based Preventive Intervention for Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Mean Time Spent Using the Intervention
研究概览
简要总结
This study will evaluate the impact of a psychosocial intervention, Coping Coach, delivered online to children who have experience an acute medical event.
The core study hypotheses are that children receiving the intervention will (1) endorse fewer maladaptive trauma-related appraisals and (2) demonstrate more adaptive coping (more support-seeking, more cognitive restructuring, less avoidant coping) at a 6-week follow-up, and (3) demonstrate lower severity of post traumatic stress (PTS) symptoms and higher health related quality of life (HRQOL) at 12 week follow-up.
详细描述
The purpose of this study is to evaluate the feasibility and provide an initial evaluation of the efficacy of Coping Coach, a new web-based intervention for children experiencing acute medical events.
The study aims to (1) assess and maximize intervention feasibility, (2) conduct an initial efficacy testing (pilot RCT) for proximal outcomes (appraisals, coping) and subsequent child health outcomes (PTS reactions, HRQOL), and (3) refine the conceptual framework and optimize the intervention effectiveness.
Study Design:
This study will progress in multiple stages:
Pilot study: 20 children experiencing a potentially traumatic medical event will be given the Coping Coach intervention with follow-up at 6 weeks. This pilot will examine initial feasibility, usability, acceptability, and child engagement/ comprehension of the intervention.
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
- •Subject is 8 to 12 years of age
- •Child has experienced a potentially traumatic medical event* within the past 2 weeks
- •Child's GCS > 12
- •Child speaks English well enough to complete the measures and participate in an interview
- •Child has access to the Internet and telephone
- •Parental/legal guardian informed consent and child assent
排除标准
- •Child's current medical condition or cognitive limitations preclude participating in an interview
- •Child's acute medical event is due to family violence or suspected child abuse
- •Child or parent has been arrested or is subject to legal proceedings related to the index incident
- •In the index event, child or parent was a perpetrator of violence (or participant in mutual violence)
结局指标
主要结局
Mean Time Spent Using the Intervention
时间窗: 6 weeks
Feasibility was measured using automated monitoring data. Mean time spent using the online intervention, across all sessions, in minutes is reported here.
Feasibility of the Coping Coach Online Intervention
时间窗: 6 weeks
Feasibility was measured using automated monitoring data, the number of participants who logged in at least once and the number of participants who completed the entire online intervention are presented here.
次要结局
- a Preliminary Assessment of the Efficacy of the Intervention(12 weeks)