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

Concussion, Brain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04099329
• Other study ID #: STUDY00000972
• Status: Completed
• Phase: N/A
• Start date: August 24, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: January 2022
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not willing to complete surveys

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain

Intervention

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

Locations

Country	Name	City	State
United States	Sara P Chrisman	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Feinberg School of Medicine, Northwestern University, Georgia Southern University, University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change, Expectations regarding concussion reporting (CR-E)	Self-report survey of Athlete expectations regarding reporting concussive symptoms	Baseline, 4-6 weeks, 9-12 weeks
Secondary	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	Baseline, 4-6 weeks, 9-12 weeks
Secondary	Change, Perceived coach, parent and peer norms regarding concussion reporting (PN-PWCS)	Self-report survey, Athlete perception of norms regarding concussion reporting	Baseline, 4-6 weeks, 9-12 weeks
Secondary	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	Baseline, 4-6 weeks, 9-12 weeks
Secondary	Change, Youth sport values (YSV)	Self-report survey, Athlete values regarding sport participation	Baseline, 4-6 weeks, 9-12 weeks
Secondary	Self-report of concussion diagnosis	Athlete report of concussion diagnosis during the season	9-12 weeks
Secondary	Change, Expectations regarding reporting teammate concussion (bystander reporting) (E-BR)	Self-report survey, Athlete intention to report teammate concussive symptoms	Baseline, 4-6 weeks, 9-12 weeks
Secondary	Change, Prosocial and Antisocial Behavior in Sport Scale (PABSS)	Self-report survey, Standardized measure of sportsmanship	Baseline, 4-6 weeks, 9-12 weeks
Secondary	Performed behavior, concussion reporting (PB--CR)	Self-report survey, Athlete concussion symptoms following potential concussion during season	9-12 weeks
Secondary	Acceptability of Intervention Measure (AIM-2) and Feasibility of Intervention Measure (AIM-2, FIM-2)	Self-report survey, Standardized measures of acceptability and feasibility	9-12 weeks