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

NCT06368050 | Completed DMC

• 1 other identifier: IRB00067187.2
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head Injury; Sport Injury

Keywords

Sport Safety; Youth Football; Head Impact Exposure

Outcome Measures

Primary Outcomes (10)

• 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 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

• 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 Outcomes (4)

• Feasibility of Intervention Measure (FIM) Values

  up to 13 weeks

• Acceptability of Intervention Measure (AIM) Values

  up to 13 weeks

• Number of practices the intervention was implemented as prescribed

  up to 13 weeks

• Average minutes per practice of live time

  up to 13 weeks

Study Arms (2)

No Intervention

NO INTERVENTION

Unexposed practice group

Experimental - practice structure intervention

EXPERIMENTAL

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

Interventions

practice structure intervention BEHAVIORAL

practice structure intervention

Experimental - practice structure intervention

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Childress Institute: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Officials

• Jill Urban, PhD, MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: July 2, 2024
• Primary Completion: November 9, 2024
• Study Completion: November 9, 2024
• Last Updated: February 4, 2025

Record last verified: 2024-04

Locations

US (1)