Evaluating Huddles as a Novel Approach to Improving Concussion Safety

NCT06864611 | Not Yet Recruiting

• 1 other identifier: 1R01HD114797-01A1
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Mild Traumatic Brain Injury

Keywords

concussion; brain injury; prevention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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)

Study Arms (2)

US Soccer concussion education as usual.

NO INTERVENTION

Currently, US Soccer makes web-based concussion education information available, including a video about concussion reporting called "Recognize to Recover."

Pre-Game Safety Huddles

EXPERIMENTAL

Behavioral: Pre-Game Safety Huddles

Interventions

Pre-Game Safety Huddles BEHAVIORAL

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)

Pre-Game Safety Huddles

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cannot read and write English

Sponsors & Collaborators

• Seattle Children's Hospital: lead

MeSH Terms

Conditions

Brain Concussion; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Emily Kroshus

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Kroshus

CONTACT

206-884-5326; emily.kroshus@seattlechildrens.org

Sara Chrisman

CONTACT

206-884-5326; sara.chrisman@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 7, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months and ending 36 months following publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.