Evaluating Huddles as a Novel Approach to Improving Concussion Safety

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

Study Overview

• Status: Not yet recruiting
• Conditions: Mild Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Pre-Game Safety Huddles

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 Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Kroshus; Phone Number: 206-884-5326; Email: emily.kroshus@seattlechildrens.org
• Study Contact Backup: Name: Sara Chrisman; Phone Number: 206-884-5326; Email: sara.chrisman@seattlechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: US Soccer concussion education as usual.; Currently, US Soccer makes web-based concussion education information available, including a video about concussion reporting called "Recognize to Recover."
Experimental: Pre-Game Safety Huddles	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expected concussion reporting behavior (Concussion Reporting- Expectations scale)	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.	Baseline, 10 weeks (end of regular competitive season)
Identification of suspected concussions	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).	Baseline, 10 weeks (end of regular competitive season)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived concussion reporting norms - Athlete (CR-N)	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.	Baseline, 10 weeks (end of regular competitive season)
Perceived concussion reporting norms - Coach (CR-N)	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.	Baseline, 10 weeks (end of regular competitive season)
Huddle implementation	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.	10 weeks (end of regular competitive season), 1 year and 10 weeks (end of following year's regular competitive season)

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Investigators: Principal Investigator: Emily Kroshus, Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: prevention; brain injury; concussion
• Additional Relevant MeSH Terms: Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Concussion
• Other Study ID Numbers: 1R01HD114797-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in a publication, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following publication.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No