COmmunities Aligned to Reduce Concussion and Head Impact Exposure (COACH)

COmmunities Aligned to Reduce Concussion and Head Impact Exposure (COACH)

Head impacts in collision sports such as football are a public health concern, as repetitive head impacts, even if a concussion is not suspected, have negative effects on brain health. This study has partnered with a community stakeholder group to create a safety program for youth football named "COmmunities Aligned to reduce Concussion and Head impact exposure (COACH)", which seeks to improve knowledge and skills of youth coaches in effective and safe practice planning and to change attitudes and beliefs to prevent head impacts and promote safety. To continue advancing COACH as an approach to prevent head injuries in youth football, this R01 Research Project Grant will determine the ability of youth football organizations to adopt COACH and test if COACH is effective in reducing head impacts, concussion, and negative effects of brain health while monitoring how the program is implemented.

Study Overview

• Status: Recruiting
• Conditions: Concussions
• Intervention / Treatment: Behavioral: COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) Intervention

Detailed Description

Football has a high risk of concussion and incidence of subconcussive head impacts which have long-lasting negative effects on brain health. With roughly 3.5 million athletes participating in youth football each year, there is a critical need to reduce head impact exposure and concussion risk. Over an entire season, most of an athlete's head impact exposure is attributed to practice. Coach-directed activities (e.g., practice drills) influence the frequency and severity of head impact exposure. Practices are amenable to intervention; however, youth football leagues are often community-run organizations with limited resources, making implementation and enforcement of injury prevention strategies a challenge. Thus, engaging community members is essential for successful development, implementation, and sustenance of interventions. This study partnered with a community stakeholder group to co-design and implement an evidence-based intervention program: COmmunities Aligned to reduce Concussion and Head impact exposure (COACH). COACH seeks to improve knowledge and skills of youth football coaches in effective practice planning that incorporates safe drills and to change attitudes and beliefs toward contact in practice. COACH has been pilot tested in two teams and shown to be acceptable and feasible. A critical next step of this research is the pragmatic evaluation of the effectiveness of COACH on a larger scale, while identifying factors that influence implementation. This study addresses this critical next step by determining the capacity of youth football organizations to adopt COACH and by testing COACH's effectiveness while monitoring the implementation process.

• Study Type: Interventional
• Enrollment (Estimated): 880
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jillian Urban, PhD, MPH; Phone Number: 602-809-0824; Email: jurban@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Jillian Urban, PhD, MPH; Phone Number: 602-809-0824; Email: jurban@wakehealth.edu
      • Principal Investigator: Jillian Urban, PhD, MPH

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participants without braces

Exclusion Criteria:

• Athletes will be excluded from participation if they currently have braces or plan to have braces during the football season, 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: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: practice intervention; head impact outcomes will be monitored from athletes enrolled on teams participating in the COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) intervention

Behavioral: COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) Intervention; COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) includes use of practice plans and a resource booklet aligned with the National Federation for High School guidelines for contact in practice. Coaches will also attend a pre-season coaches' clinic and be paired with a peer mentor during the season.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of practice impacts	Total number of head impacts measured during the season in practices - 0-500 impacts	3 months
linear acceleration of practice impacts	Median peak resultant linear acceleration measured during the season in practices - 8-45 g of linear acceleration	3 months
rotational acceleration of practice impacts	Median peak resultant rotational acceleration measured during the season in practices - Median peak resultant linear acceleration measured during the season in practices - 8-45 g of linear acceleration - 100-1500 rad/s^2	3 months
Change in verbal memory composite (ImPACT) scores	Pre- to post-season change in attentional processes, learning, and memory within the verbal domain - range: 60-100; The composite score represents the average performance across three subtasks. A higher score indicates better performance.	3 months
Change in visual memory composite (ImPACT) scores	Pre- to post-season change in visual attention and scanning, learning, and memory - range :40-100 The composite score represents the average performance across two subtasks. A higher score indicates better performance.	3 months
Change in visual motor speed composite (ImPACT) scores	Pre- to post-season change in visual processing, learning and memory, and visual-motor response speed - range: 20-50 The composite score represents the average performance across two subtasks. A higher score indicates better performance.	3 months
Change in reaction time composite (ImPACT) scores	Pre- to post-season change in response speed - range: 0-1; The composite score represents the average performance across three subtasks. A lower score indicates better performance.	3 months
Change in Flanker Task (NIH Toolbox) Scores	Pre- to post-season change in inhibitory control and attention; range: 0-10 - Scoring is based on a combination of accuracy and reaction time. A higher score indicates better performance.	3 months
Change in pattern comparison (NIH Toolbox) Scores	Pre- to post-season change in processing speed; range: 0-130 - Raw score is the number of items correctly in 85 seconds; score is then converted to a normative standard score. A higher score indicates better performance.	3 months
Change in list sorting (NIH Toolbox) Scores	Pre- to post-season change in working memory; range: 0-26 - Scored by summing the total number of items correctly recalled and sequenced, then converted to a nationally normed score. A higher score indicates better performance.	3 months
Change in Postural Control Scores	participants will complete two 30-second trials (one with eyes opened, one with eyes closed). Five measurements will be calculated at each time point (pre- and post-season): anterior-posterior sway, medial-lateral sway, path length, maximum path velocity, and center of pressure area.	3 months
Change in Conners' Continuous Performance Test (CPT) Scores	Participants will complete a 14-minute computer-based assessment that evaluates selective, sustained and divided attention, as well as impulsivity and vigilance - If the T-score is below 60, it is usually unlikely that the individual has ADHD. A score above 60 might suggest Attention-deficit/hyperactivity disorder (ADHD), and if it's over 70, it could indicate more serious symptoms. Scores ranging from 0-177 with higher scores denoting more symptoms	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention fidelity percentage of implementation	Implementation score representing the percentage of practices the intervention was implemented as prescribed - 0-100% - higher percent denoting more implementation	3 months
Adaptation of the intervention (AIM) score	5-point Likert scale of the acceptability of the intervention - 0-5 - higher scores denoting more adaptation	pre-season
Feasibility of the Intervention (FIM) score	5-point Likert scale of the feasibility of the intervention - 0-5 - higher scores denoting higher feasibility	pre-season

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Jillian Urban, PhD, MPH, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: subconcussive head impacts; football injuries; head impact exposure
• Additional Relevant MeSH Terms: Investigative Techniques; Methods
• Other Study ID Numbers: IRB00119368; R01HD116966 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant data that underlie the primary outcomes reported in papers after deidentification
• IPD Sharing Time Frame: 6 months After Publication
• IPD Sharing Access Criteria: Researches who provide a methodologically sound proposal; to achieve the aims of the approved proposal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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