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

Primary Purpose

Concussion, Brain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-game Safety Huddles
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Concussion, Brain focused on measuring Soccer, Football, Injury, Prevention, Concussion, Education, Huddles, Primary prevention, Secondary prevention, Behavioral intervention

Eligibility Criteria

11 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Not willing to complete surveys

Sites / Locations

  • Sara P Chrisman

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pre-game Safety Huddles

Control

Arm Description

Pre-game safety huddles will occur before each game and athletes and coaches will be surveyed.

No intervention will be delivered by athletes and coaches will be surveyed.

Outcomes

Primary Outcome Measures

Change, Expectations regarding concussion reporting (CR-E)
Self-report survey of Athlete expectations regarding reporting concussive symptoms

Secondary Outcome Measures

Change, Expectations of engaging in potentially injurious play (IP-E)
Self-report survey of Athlete rating of expectations of engaging in potentially risky sport behavior
Change, Perceived coach, parent and peer norms regarding concussion reporting (PN-PWCS)
Self-report survey, Athlete perception of norms regarding concussion reporting
Change in Perceived coach (TN-C), parent (TN-P) and peer norms (TN-T) regarding sportsmanship
Self-report survey, Athlete perception of norms regarding sportsmanship
Change, Youth sport values (YSV)
Self-report survey, Athlete values regarding sport participation
Self-report of concussion diagnosis
Athlete report of concussion diagnosis during the season
Change, Expectations regarding reporting teammate concussion (bystander reporting) (E-BR)
Self-report survey, Athlete intention to report teammate concussive symptoms
Change, Prosocial and Antisocial Behavior in Sport Scale (PABSS)
Self-report survey, Standardized measure of sportsmanship
Performed behavior, concussion reporting (PB--CR)
Self-report survey, Athlete concussion symptoms following potential concussion during season
Acceptability of Intervention Measure (AIM-2) and Feasibility of Intervention Measure (AIM-2, FIM-2)
Self-report survey, Standardized measures of acceptability and feasibility

Full Information

First Posted
August 7, 2019
Last Updated
January 25, 2022
Sponsor
Seattle Children's Hospital
Collaborators
Georgia Southern University, University of Oregon, Northwestern University Feinberg School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04099329
Brief Title
One Team: Changing the Culture of Youth Sport With Pregame Safety Huddles
Official Title
One Team: Changing the Culture of Youth Sport With Pregame Safety Huddles
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 24, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
Georgia Southern University, University of Oregon, Northwestern University Feinberg School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain
Keywords
Soccer, Football, Injury, Prevention, Concussion, Education, Huddles, Primary prevention, Secondary prevention, Behavioral intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Leagues were randomized to intervention or control
Masking
Investigator
Masking Description
Data masked for analysis
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-game Safety Huddles
Arm Type
Experimental
Arm Description
Pre-game safety huddles will occur before each game and athletes and coaches will be surveyed.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention will be delivered by athletes and coaches will be surveyed.
Intervention Type
Behavioral
Intervention Name(s)
Pre-game Safety Huddles
Intervention Description
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
Primary Outcome Measure Information:
Title
Change, Expectations regarding concussion reporting (CR-E)
Description
Self-report survey of Athlete expectations regarding reporting concussive symptoms
Time Frame
Baseline, 4-6 weeks, 9-12 weeks
Secondary Outcome Measure Information:
Title
Change, Expectations of engaging in potentially injurious play (IP-E)
Description
Self-report survey of Athlete rating of expectations of engaging in potentially risky sport behavior
Time Frame
Baseline, 4-6 weeks, 9-12 weeks
Title
Change, Perceived coach, parent and peer norms regarding concussion reporting (PN-PWCS)
Description
Self-report survey, Athlete perception of norms regarding concussion reporting
Time Frame
Baseline, 4-6 weeks, 9-12 weeks
Title
Change in Perceived coach (TN-C), parent (TN-P) and peer norms (TN-T) regarding sportsmanship
Description
Self-report survey, Athlete perception of norms regarding sportsmanship
Time Frame
Baseline, 4-6 weeks, 9-12 weeks
Title
Change, Youth sport values (YSV)
Description
Self-report survey, Athlete values regarding sport participation
Time Frame
Baseline, 4-6 weeks, 9-12 weeks
Title
Self-report of concussion diagnosis
Description
Athlete report of concussion diagnosis during the season
Time Frame
9-12 weeks
Title
Change, Expectations regarding reporting teammate concussion (bystander reporting) (E-BR)
Description
Self-report survey, Athlete intention to report teammate concussive symptoms
Time Frame
Baseline, 4-6 weeks, 9-12 weeks
Title
Change, Prosocial and Antisocial Behavior in Sport Scale (PABSS)
Description
Self-report survey, Standardized measure of sportsmanship
Time Frame
Baseline, 4-6 weeks, 9-12 weeks
Title
Performed behavior, concussion reporting (PB--CR)
Description
Self-report survey, Athlete concussion symptoms following potential concussion during season
Time Frame
9-12 weeks
Title
Acceptability of Intervention Measure (AIM-2) and Feasibility of Intervention Measure (AIM-2, FIM-2)
Description
Self-report survey, Standardized measures of acceptability and feasibility
Time Frame
9-12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Sara P Chrisman
City
Seattle
State/Province
Washington
ZIP/Postal Code
98136
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36113984
Citation
Kroshus E, Chrisman SPD, Glang A, Hunt T, Hays R, Lowry S, Peterson A, Garrett K, Ramshaw D, Hafferty K, Kinney E, Manzueta M, Steiner MK, Bollinger BJ, Chiampas G, Rivara FP. Concussion education for youth athletes using Pre-Game Safety Huddles: a cluster-randomised controlled trial. Inj Prev. 2023 Feb;29(1):22-28. doi: 10.1136/ip-2022-044665. Epub 2022 Sep 16.
Results Reference
derived

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

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