Popular Opinion Leaders as a Sports Concussion Prevention Strategy in Middle Schools-The TRAIN Study, a Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Concussion-Related Beliefs Change Score
研究概览
简要总结
Purpose: The purpose of this study is to evaluate the effectiveness of a theory-driven intervention (TRAIN concussion education) to improve parental concussion-related attitudes, beliefs, intentions, confidence in knowledge, and self-efficacy.
Participants: 180 parents of United States middle school aged children whose children have been engaged in organized sports within the past 2 years.
Procedures: The study is a single-blind (participants) randomized control trial. The investigators will randomize eligible parents into two groups: (1) control (standard concussion education); and treatment (standard concussion education AND TRAIN concussion education) to evaluate the effectiveness of the TRAIN concussion education intervention.
详细描述
A convenience sample of participants will be recruited from parents of United States middle school aged children whose children have been engaged in organized sports within the past 2 years. Interested parents will contact study stuff, who will ensure eligibility criteria are met.
Upon this, and completing the written informed consent process, participants will be assigned a unique identifier and randomized (simple) without replacement to one of the two study arms (control vs. treatment), using a predetermined random number generator in Excel.
Participants in the control group will receive standard concussion education materials focused on concussion prevention in youth sport. Participants in the treatment group will receive the same standard concussion education materials AND the TRAIN concussion education module. The TRAIN education module is grounded in a theoretical structure inclusive of the original intervention tenants of the Popular Opinion Leader (POL) and Diffusion of Innovations frameworks, and within the context of the socioecological model.
Participants will complete a self-administered online pre-test survey, which includes assessments of concussion-related attitudes, beliefs, intentions, confidence in knowledge, and self-efficacy. After completion of the pre-test survey, participants will complete their assigned intervention (TRAIN concussion education module + standard concussion education materials versus standard concussion education materials only).
Upon completion of their assigned intervention, participants will complete the online survey again to obtain post-test measures (post-test survey). Participants will also be scheduled to complete individual semi-structured interviews.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult with a child/children enrolled in a United States middle school
- •Adult whose child has participated in organized sports in the past 2 years
排除标准
- •Adult without a child/children enrolled in a United States middle school
结局指标
主要结局
Concussion-Related Beliefs Change Score
时间窗: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
Participants are asked 6 questions concerning beliefs related to concussion risk, symptoms, and management. These items are added together to compute an overall score. Scoring scale ranges from a minimum of 6 to a maximum 24, where a higher score indicated more favorable beliefs. A change score will be computed post score-pre score.
Concussion-Related Attitudes Change Score
时间窗: Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion)
Participants are asked 20 survey items identifying an individual's attitudes about a certain behavior (e.g., seeking care). Each item is added together to compute an overall attitude score. Scoring scale ranges from a minimum of 20 to a maximum of 140, where higher scores indicate more favorable attitudes. A change score will be computed post score-pre score.
次要结局
- Confidence in Concussion-Related Knowledge Change Score(Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion))
- Concussion-Related Intentions Change Score(Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion))
- Concussion-Related Self-Efficacy Change Score(Baseline (pre-intervention) and follow-up (post intervention approximately 7-30 days after intervention completion))