NCT06864611

Evaluating Huddles as a Novel Approach to Improving Concussion Safety

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 9 Years
• Healthy volunteers: Accepted

Summary

Investigators will conduct a randomized controlled trial assessing the effectiveness and implementations of Pre-Game Safety Huddles (Huddles) in youth soccer.

Detailed description

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.

Conditions

• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
BEHAVIORAL	Pre-Game Safety Huddles	Before every regular season game, participating teams in league randomized to the Pre-Game Safety Huddle condition will hold brief Pre-Game Safety Huddles. Pre-Game Safety Huddles have three core components: (1) Gather (Athletes, coaches, officials, and other stakeholders come together before the start of the game); (2) Share (Opinion leaders (coaches, referees) affirm the importance of seeking care for suspected concussion, and (3) Repeat (Process is repeated before every game)

Timeline

• Start date: 2026-09-01
• Primary completion: 2030-04-30
• Completion: 2030-04-30
• First posted: 2025-03-07
• Last updated: 2026-03-20