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NCT Number: NCT06864611

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.

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Key information

Conditions

Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Expected concussion reporting behavior (Concussion Reporting- Expectations scale)

    Time frame: 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.

  2. Identification of suspected concussions

    Time frame: 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 outcomes

  1. Perceived concussion reporting norms - Athlete (CR-N)

    Time frame: 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.

  2. Perceived concussion reporting norms - Coach (CR-N)

    Time frame: 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.

  3. Huddle implementation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Kroshus

CONTACT

[email protected]

206-884-5326

Sara Chrisman

CONTACT

[email protected]

206-884-5326

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 7, 2025
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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