NCT04099329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

August 24, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

August 7, 2019

Last Update Submit

January 25, 2022

Conditions

Keywords

SoccerFootballInjuryPreventionConcussionEducationHuddlesPrimary preventionSecondary preventionBehavioral intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Change, Expectations of engaging in potentially injurious play (IP-E)

    Baseline, 4-6 weeks, 9-12 weeks

  • Change, Perceived coach, parent and peer norms regarding concussion reporting (PN-PWCS)

    Baseline, 4-6 weeks, 9-12 weeks

  • Change in Perceived coach (TN-C), parent (TN-P) and peer norms (TN-T) regarding sportsmanship

    Baseline, 4-6 weeks, 9-12 weeks

  • Change, Youth sport values (YSV)

    Baseline, 4-6 weeks, 9-12 weeks

  • Self-report of concussion diagnosis

    9-12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Pre-game Safety Huddles

EXPERIMENTAL

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

Behavioral: Pre-game Safety Huddles

Control

NO INTERVENTION

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

Interventions

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

Pre-game Safety Huddles

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Not willing to complete surveys

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sara P Chrisman

Seattle, Washington, 98136, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Brain ConcussionWounds and Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds, Nonpenetrating

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Data masked for analysis
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Leagues were randomized to intervention or control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 7, 2019

First Posted

September 23, 2019

Study Start

August 24, 2019

Primary Completion

January 1, 2020

Study Completion

March 1, 2020

Last Updated

January 31, 2022

Record last verified: 2022-01

Locations