Evaluating Huddles As a Novel Approach to Improving Concussion Safety

Not Applicable

Not yet recruiting

• Conditions: Mild Traumatic Brain Injury

• Registration Number: NCT06864611
• Lead Sponsor: Seattle Children's Hospital

Brief 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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07
• Study Start: 2025-07-01
• Primary Completion: 2030-06-30
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• 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

Exclusion Criteria

• Cannot read and write English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Expected concussion reporting behavior (Concussion Reporting- Expectations scale)	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	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).

Secondary Outcome Measures

Name	Time	Method
Perceived concussion reporting norms - Athlete (CR-N)	Baseline, 10 weeks (end of regular competitive season)	CR-N is a 4-item scale that assesses the coach's perception that coaches in their organization would want athletes to report suspected concussive symptoms. Responses to four scenarios are measured on a 4-point Likert scale, with higher sores indicating a stronger perceived norms in support of reporting future post-impact concussive symptoms.
Perceived concussion reporting norms - Coach (CR-N)	Baseline, 10 weeks (end of regular competitive season)	CR-N is a 4-item scale that assesses the coach's perception that coaches in their organization would want athletes to report suspected concussive symptoms. Responses to four scenarios are measured on a 4-point Likert scale, with higher sores indicating a stronger perceived norms in support of reporting future post-impact concussive symptoms.
Huddle implementation	10 weeks (end of regular competitive season), 1 year and 10 weeks (end of following year's regular competitive season)	Administrative data will be used to record the number of games before which Huddles occurred, which will be expressed as a rate with a denominator of Huddle-eligible games.