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One Team: Changing the Culture of Youth Sport With Pregame Safety Huddles

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ClinicalTrials.gov Identifier: NCT04099329
Recruitment Status : Completed
First Posted : September 23, 2019
Last Update Posted : January 31, 2022
Sponsor:
Collaborators:
Georgia Southern University
University of Oregon
Northwestern University Feinberg School of Medicine
Information provided by (Responsible Party):
Sara PD Chrisman, MD MPH, Seattle Children's Hospital

Study Description
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Brief Summary:
Randomized controlled trial of a behavioral intervention (Pre-Game Safety Huddles) designed to study the impact of huddles on concussion safety in youth sport, primarily regarding intention to report concussive symptoms.

Condition or disease Intervention/treatment Phase
Concussion, Brain Behavioral: Pre-game Safety Huddles Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Leagues were randomized to intervention or control
Masking: Single (Investigator)
Masking Description: Data masked for analysis
Primary Purpose: Prevention
Official Title: One Team: Changing the Culture of Youth Sport With Pregame Safety Huddles
Actual Study Start Date : August 24, 2019
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pre-game Safety Huddles
Pre-game safety huddles will occur before each game and athletes and coaches will be surveyed.
 Behavioral: Pre-game Safety Huddles
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
No Intervention: Control
No intervention will be delivered by athletes and coaches will be surveyed.


Outcome Measures
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Primary Outcome Measures :
  1. Change, Expectations regarding concussion reporting (CR-E) [ Time Frame: Baseline, 4-6 weeks, 9-12 weeks ]
    Self-report survey of Athlete expectations regarding reporting concussive symptoms


Secondary Outcome Measures :
  1. 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

  2. Change, Perceived coach, parent and peer norms regarding concussion reporting (PN-PWCS) [ Time Frame: Baseline, 4-6 weeks, 9-12 weeks ]
    Self-report survey, Athlete perception of norms regarding concussion reporting

  3. 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 ]
    Self-report survey, Athlete perception of norms regarding sportsmanship

  4. Change, Youth sport values (YSV) [ Time Frame: Baseline, 4-6 weeks, 9-12 weeks ]
    Self-report survey, Athlete values regarding sport participation

  5. Self-report of concussion diagnosis [ Time Frame: 9-12 weeks ]
    Athlete report of concussion diagnosis during the season

  6. Change, Expectations regarding reporting teammate concussion (bystander reporting) (E-BR) [ Time Frame: Baseline, 4-6 weeks, 9-12 weeks ]
    Self-report survey, Athlete intention to report teammate concussive symptoms

  7. Change, Prosocial and Antisocial Behavior in Sport Scale (PABSS) [ Time Frame: Baseline, 4-6 weeks, 9-12 weeks ]
    Self-report survey, Standardized measure of sportsmanship

  8. Performed behavior, concussion reporting (PB--CR) [ Time Frame: 9-12 weeks ]
    Self-report survey, Athlete concussion symptoms following potential concussion during season

  9. Acceptability of Intervention Measure (AIM-2) and Feasibility of Intervention Measure (AIM-2, FIM-2) [ Time Frame: 9-12 weeks ]
    Self-report survey, Standardized measures of acceptability and feasibility


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participating on a team in one of the recruited leagues and willing to complete surveys

Exclusion Criteria:

  • Not willing to complete surveys
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099329


Locations
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United States, Washington
Sara P Chrisman
Seattle, Washington, United States, 98136
Sponsors and Collaborators
Seattle Children's Hospital
Georgia Southern University
University of Oregon
Northwestern University Feinberg School of Medicine
  Study Documents (Full-Text)

Documents provided by Sara PD Chrisman, MD MPH, Seattle Children's Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] January 10, 2022
Informed Consent Form  [PDF] November 13, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sara PD Chrisman, MD MPH, Associate Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT04099329    
Other Study ID Numbers: STUDY00000972
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: January 31, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sara PD Chrisman, MD MPH, Seattle Children's Hospital:
Soccer
Football
Injury
Prevention
Concussion
 Education
Huddles
Primary prevention
Secondary prevention
Behavioral intervention
Additional relevant MeSH terms:
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Brain Concussion
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating