Evaluating Huddles as a Novel Approach to Improving Concussion Safety
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 主要终点
- Expected concussion reporting behavior (Concussion Reporting- Expectations scale)
研究概览
简要总结
Investigators will conduct a randomized controlled trial assessing the effectiveness and implementations of Pre-Game Safety Huddles (Huddles) in youth soccer.
详细描述
The clinical trial portion of this study will enroll 16 youth soccer leagues within four US states. Within each participating league we will enroll two "brackets" (closed units of teams at the same level that compete against each other during the regular season of play) of U12 boys' and girls' U12 teams. Based on typical league and bracket size we anticipate will be 384 teams. Randomization will happen at the league-level. Leagues in the Huddle intervention condition will be supported by US Soccer in implementing Pre-Game Safety Huddles before each regular season game. Leagues in the control condition will continue US Soccer's standard concussion education prevention activities.
Our primary effectiveness and implementation outcomes will be measured at the end of the regular season of play (anticipated to be 10 weeks). Maintenance outcomes will be measured at the end of the regular season of play one year later.
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
- None
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between the ages of 9 and 13 on eligible teams in participating leagues.
- •Soccer coaches of children between the ages of 9 and 13 on eligible teams in participating leagues.
- •Read and write English
排除标准
- •Cannot read and write English
结局指标
主要结局
Expected concussion reporting behavior (Concussion Reporting- Expectations scale)
时间窗: Baseline, 10 weeks (end of regular competitive season)
Concussion Reporting- Expectations (CR-E), a 4-item scale that assesses athlete's expectations that they would tell a coach or other trusted adult about post-impact concussive symptoms in naturalistic scenarios. Responses are measured on a 4-point Likert scale, with higher sores indicating a stronger expectation that they would report future post-impact concussive symptoms.
Identification of suspected concussions
时间窗: Baseline, 10 weeks (end of regular competitive season)
Identification of suspected concussions will be measured via coach report as the number of times per season an athlete was identified as having a possible concussion (from 1- athlete-report to a coach, medical personnel or parent report to a coach, or 2- athlete removal from play for suspected concussive symptoms without report, for example due to loss of consciousness). This will be expressed as a team-level rate (number of instances/number of athletes per team).
次要结局
- Perceived concussion reporting norms - Athlete (CR-N)(Baseline, 10 weeks (end of regular competitive season))
- Perceived concussion reporting norms - Coach (CR-N)(Baseline, 10 weeks (end of regular competitive season))
- Huddle implementation(10 weeks (end of regular competitive season), 1 year and 10 weeks (end of following year's regular competitive season))
研究者
Emily Kroshus
Research Associate Professor
Seattle Children's Hospital