Evaluating Huddles As a Novel Approach to Improving Concussion Safety

NCT ID: NCT06864611

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2030-06-30

Brief Summary

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

Detailed Description

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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

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Mild Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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."

Group Type NO_INTERVENTION

No interventions assigned to this group

Pre-Game Safety Huddles

Group Type EXPERIMENTAL

Pre-Game Safety Huddles

Intervention Type 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)

Interventions

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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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Emily Kroshus

Research Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily Kroshus

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Central Contacts

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Emily Kroshus

Role: CONTACT

206-884-5326

Sara Chrisman

Role: CONTACT

206-884-5326

Other Identifiers

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1R01HD114797-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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