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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head Injury; Sport Injury
• Intervention / Treatment: Behavioral: practice structure intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jill Urban, PhD, MPH; Phone Number: 336.716.0947; Email: jurban@wakehealth.edu
• Study Contact Backup: Name: Konstantia Strates; Phone Number: 336.713.1263; Email: kcstrate@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
      • Contact: Konstantia Strates; Phone Number: 336-713-1263; Email: kcstrate@wakehealth.edu
      • Contact: Jill Urban, PhD, MPH; Phone Number: 336-716-0947; Email: jurban@wakehealth.edu
      • Principal Investigator: Jill Urban, PhD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Intervention; Unexposed practice group
Experimental: Experimental - practice structure intervention; Athletes of teams at the 12U and 13U level pilot testing the intervention program. On-field activity will be monitored with head impact sensors and video to evaluate the effectiveness of the intervention program.	Behavioral: practice structure intervention; practice structure intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median linear acceleration	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median linear acceleration.	Month 3
Median rotational acceleration	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational acceleration.	Month 3
Number of practice head impacts	Number of verified direct head impacts measured in practice over the entire season.	Month 3
Number of practice head acceleration events	Number of verified direct and indirect head acceleration events measured in practice over the entire season.	Month 3
Practice head impact rate	Rate of verified direct head impacts per athlete per practice	Month 3
Practice head acceleration even rate	Rate of verified direct and indirect head acceleration events per athlete per practice	Month 3
Median rotational velocity	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational velocity	Month 3
95th percentile linear acceleration	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile linear acceleration	Month 3
95th percentile rotational acceleration	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational acceleration	Month 3
95th percentile rotational velocity	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational velocity	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Intervention Measure (FIM) Values	Perceived feasibility - higher values denote better feasibility - total range 0 - 5	up to 13 weeks
Acceptability of Intervention Measure (AIM) Values	Higher values denote better acceptability - total range 0 - 5	up to 13 weeks
Number of practices the intervention was implemented as prescribed	The extent to which the intervention was implemented as prescribed. Descriptive data and inferential statistics will be used. Common themes will be grouped, and qualitative data indexed and charted	up to 13 weeks
Average minutes per practice of live time	Minutes per practice spent on live tackling	up to 13 weeks

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Childress Institute
• Investigators: Principal Investigator: Jill Urban, PhD, MPH, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Sport Safety; Youth Football; Head Impact Exposure
• Additional Relevant MeSH Terms: Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Craniocerebral Trauma; Athletic Injuries
• Other Study ID Numbers: IRB00067187.2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No