Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099329
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : March 31, 2020
Sponsor:
Collaborators:
Georgia Southern University
University of Oregon
Feinberg School of Medicine, Northwestern University
Information provided by (Responsible Party):
Sara Chrisman, Seattle Children's Hospital

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) intention to report concussive symptoms and 2) intention to make a play to stop an opponent that may cause a head injury.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Leagues are 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
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

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.



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


Secondary Outcome Measures :
  1. Change, Sportsmanship intentions (BI-S) [ Time Frame: Baseline, 4-6 weeks, 9-12 weeks ]
    Self-report survey of Athlete rating of likelihood of behaving in sportsmanlike manner

  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, Intention to report teammate concussion (bystander reporting) (I-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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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


Contacts
Layout table for location contacts
Contact: Rachel Hays, MPH 206-484-2133 rachel.hays@seattlechildrens.org

Locations
Layout table for location information
United States, Washington
Seattle Children's Research Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Rachel Hays, MPH       rachel.hays@seattlechildrens.org   
Principal Investigator: Sara PD Chrisman, MD MPH         
Sponsors and Collaborators
Seattle Children's Hospital
Georgia Southern University
University of Oregon
Feinberg School of Medicine, Northwestern University
Layout table for additonal information
Responsible Party: Sara Chrisman, Assistant 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: March 31, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sara Chrisman, Seattle Children's Hospital:
Soccer
Football
Injury
Prevention
Concussion
Education
Huddles
Primary prevention
Secondary prevention
Behavioral intervention
Additional relevant MeSH terms:
Layout table for MeSH terms
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