Evaluating Huddles as a Novel Approach to Improving Concussion Safety
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pre-Game Safety Huddles.
- Who it may be relevant to
- Registry conditions: Mild Traumatic Brain Injury. Basic parameters: from 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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)
Primary outcome measures
- Expected concussion reporting behavior (Concussion Reporting- Expectations scale) [Time frame: Baseline, 10 weeks (end of regular competitive season)]
- Identification of suspected concussions [Time frame: Baseline, 10 weeks (end of regular competitive season)]
Secondary outcome measures (3)
- Perceived concussion reporting norms - Athlete (CR-N) [Time frame: Baseline, 10 weeks (end of regular competitive season)]
- Perceived concussion reporting norms - Coach (CR-N) [Time frame: Baseline, 10 weeks (end of regular competitive season)]
- Huddle implementation [Time frame: 10 weeks (end of regular competitive season), 1 year and 10 weeks (end of following year's regular competitive season)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06864611 · 1R01HD114797-01A1