- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04099329
One Team: Changing the Culture of Youth Sport With Pregame Safety Huddles
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
More than 1 million youth sustain a sport-related concussion (SRC) each year. The middle school age range is particularly concerning because it is a time when children have both a unique susceptibility to brain injury and high participation rates in organized sports with concussion risk, such as soccer and football. There are two avenues to decrease concussion risk: (1) minimizing the number and force of collisions to decrease concussion incidence (primary prevention) and (2) improving concussion identification to decrease morbidity (secondary prevention). The goal of this study is to utilize Pre-Game Safety Huddles to discuss sportsmanship (primary prevention) and concussion reporting (secondary prevention) with a goal of improving concussion safety.
To assess the efficacy of Pre-Game Safety Huddles as a tool for injury prevention, we will conduct a Randomized controlled trial with youth sport teams. We will recruit leagues in the Seattle area (girls' soccer, boys' soccer and football) and randomize them to either intervention or control. Coaches in the intervention group will then be trained to lead Pre-Game Safety Huddles before each game over the course of the season (9-12 weeks). Youth and coaches will be surveyed at three time points and data will be analyzed to determine impact of the intervention on two outcomes: 1) expectations regarding reporting concussive symptoms (CR-E) and 2) expectations regarding engaging in potentially injurious play (IP-E).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98136
- Sara P Chrisman
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participating on a team in one of the recruited leagues and willing to complete surveys
Exclusion Criteria:
- Not willing to complete surveys
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pre-game Safety Huddles
Pre-game safety huddles will occur before each game and athletes and coaches will be surveyed.
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Coaches will be trained to lead Pre-game Safety Huddles by the RA with the study using a multi-media tool we have developed.
Huddles will be brief (1-2 minutes) and will primarily focused on 1) encouraging concussion reporting and 2) encouraging good sportsmanship
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No Intervention: Control
No intervention will be delivered by athletes and coaches will be surveyed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change, Expectations regarding concussion reporting (CR-E)
Time Frame: Baseline, 4-6 weeks, 9-12 weeks
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Self-report survey of Athlete expectations regarding reporting concussive symptoms
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Baseline, 4-6 weeks, 9-12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change, Expectations of engaging in potentially injurious play (IP-E)
Time Frame: Baseline, 4-6 weeks, 9-12 weeks
|
Self-report survey of Athlete rating of expectations of engaging in potentially risky sport behavior
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Baseline, 4-6 weeks, 9-12 weeks
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Change, Perceived coach, parent and peer norms regarding concussion reporting (PN-PWCS)
Time Frame: Baseline, 4-6 weeks, 9-12 weeks
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Self-report survey, Athlete perception of norms regarding concussion reporting
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Baseline, 4-6 weeks, 9-12 weeks
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Change in Perceived coach (TN-C), parent (TN-P) and peer norms (TN-T) regarding sportsmanship
Time Frame: Baseline, 4-6 weeks, 9-12 weeks
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Self-report survey, Athlete perception of norms regarding sportsmanship
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Baseline, 4-6 weeks, 9-12 weeks
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Change, Youth sport values (YSV)
Time Frame: Baseline, 4-6 weeks, 9-12 weeks
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Self-report survey, Athlete values regarding sport participation
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Baseline, 4-6 weeks, 9-12 weeks
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Self-report of concussion diagnosis
Time Frame: 9-12 weeks
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Athlete report of concussion diagnosis during the season
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9-12 weeks
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Change, Expectations regarding reporting teammate concussion (bystander reporting) (E-BR)
Time Frame: Baseline, 4-6 weeks, 9-12 weeks
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Self-report survey, Athlete intention to report teammate concussive symptoms
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Baseline, 4-6 weeks, 9-12 weeks
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Change, Prosocial and Antisocial Behavior in Sport Scale (PABSS)
Time Frame: Baseline, 4-6 weeks, 9-12 weeks
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Self-report survey, Standardized measure of sportsmanship
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Baseline, 4-6 weeks, 9-12 weeks
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Performed behavior, concussion reporting (PB--CR)
Time Frame: 9-12 weeks
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Self-report survey, Athlete concussion symptoms following potential concussion during season
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9-12 weeks
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Acceptability of Intervention Measure (AIM-2) and Feasibility of Intervention Measure (AIM-2, FIM-2)
Time Frame: 9-12 weeks
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Self-report survey, Standardized measures of acceptability and feasibility
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9-12 weeks
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000972
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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