COmmunities Aligned to Reduce Concussion and Head Impact Exposure

NCT06624202 | Recruiting

• 2 other identifiers: IRB00119368R01HD116966
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Concussions

Keywords

football injuries; subconcussive head impacts; head impact exposure

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (3)

• Intervention fidelity percentage of implementation

  3 months

• Adaptation of the intervention (AIM) score

  pre-season

• Feasibility of the Intervention (FIM) score

  pre-season

Study Arms (1)

practice intervention

EXPERIMENTAL

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

Interventions

COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) Intervention BEHAVIORAL

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.

practice intervention

Eligibility Criteria

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

You may qualify if:

• Participants without braces

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Jillian Urban, PhD, MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jillian Urban, PhD, MPH

CONTACT

602-809-0824; jurban@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Biomechanical data collection will occur during youth football practices and games.

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 2, 2024
• Study Start: May 10, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months After Publication
• Access Criteria: Researches who provide a methodologically sound proposal; to achieve the aims of the approved proposal

Locations

US (1)