Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football

Last updated: January 31, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Completed

Phase

N/A

Condition

Athletic Injuries

Brain Injury

Treatment

practice structure intervention

Clinical Study ID

NCT06368050
IRB00067187.2
  • Ages 11-14
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The objective of this study is to evaluate the feasibility of implementing an evidence-based intervention program, COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) on a larger scale. Coaches of 12U (12 years old and under), and 13U (13 years old and under) teams within six youth football organizations will pilot test the intervention. Aim 1 will conduct focus groups with coaches, parents, and organizational leaders to assess organizational needs, capacity, and readiness to adopt the intervention program. Aim 2 will evaluate the effectiveness of the intervention program at reducing HIE and injuries and evaluate implementation success. Aim 2 results (intervention outcomes) are reported herein.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All athletes participating on the prospective teams will be eligible for the study,including those with braces longer than 6 months

Exclusion

Exclusion Criteria:

  • Athletes will be excluded from participation if they have had braces less than 6months, or have dental appliances that may impede the fit of the mouthpiece device (e.g., Herbst Appliance).

Study Design

Total Participants: 34
Treatment Group(s): 1
Primary Treatment: practice structure intervention
Phase:
Study Start date:
July 02, 2024
Estimated Completion Date:
November 09, 2024

Study Description

Coaches of teams at the 12U and 13U levels within the six youth football organizations will be invited to pilot test the intervention program. Intervention outcomes will be compared to historic controls (K25HD101686 - NCT04908930). Video taken at all practices will be used to monitor team activities of 12U and 13U teams across all organizations participating in the intervention; incidence of injuries will be monitored across all teams. Athletes (n=30) enrolled across two of six participating teams will be recruited to participate in parallel biomechanical and video data collection to evaluate the frequency and severity of head impacts experienced throughout the season. Biomechanical data will be collected using instrumented mouth guards and verified with video. Preliminary effectiveness will be measured by the percentage of coaches who choose to adopt and maintain the intervention program. Head impact exposure and injury rates will be compared across the intervention and control teams.

Connect with a study center

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

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