Kids With mTBI Get SMART: Development and Pilot Trial of a Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change in quality of life, as measured by the Pediatric Quality of Life Inventory (PedsQL)
研究概览
简要总结
SMART is an interactive web-based program that will allow youth with mild traumatic brain injuries (mTBI) to monitor their symptoms and receive education on problem-solving and coping strategies. This study will evaluate the effectiveness of SMART as a means of improving symptom-management, coping skills, and general well-being during recovery from mTBI. Half of participants will receive the SMART intervention, while half will receive usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •11-18 years old
- •Sustained mTBI within the past week
排除标准
- •Patient and/or family do not speak and read English
- •Patient and/or family do not have Internet access
- •Patient experiencing more severe brain injury (Glasgow coma score <13)
- •Patient with more than one moderate extracranial injury
- •Patients with non-mTBI reasons for altered mental status
- •Patients with severe pre-existing neurologic or cognitive disorders or other disorders that may impair ability to participate in the intervention.
研究组 & 干预措施
SMART Intervention
干预措施: Self-Monitoring Activity-restriction and Relaxation Training (SMART) (Behavioral)
Usual Care
结局指标
主要结局
Change in quality of life, as measured by the Pediatric Quality of Life Inventory (PedsQL)
时间窗: From baseline to 4 weeks post-injury
The PedsQL includes 23 items measuring physical, emotional, social, and school functioning.
次要结局
- Change in coping strategies, as measured by the Coping Strategies Inventory (CSI-S: Short Form)(From baseline to 4 weeks post-injury)
- Change in self-efficacy for symptom management, as measured by the Self-Efficacy Scale (S-eS)(From baseline to 4 weeks post-injury)
- Change in general functioning, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)(From baseline to 4 weeks post-injury)
- Change in health and behavioral symptoms, as measured by the Health and Behavior Inventory (HBI)(From baseline to 4 weeks post-injury)