Recruiting

COACH Program

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06624202

Conditions

Concussions

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Accepted

Interventions

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

Study Details

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

Study ID

NCT06624202

Start date

May 10, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Accepted

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 Design

Enrollment

880 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

Interventions

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.

Primary outcome measure

  • Number of practice impacts [ Time Frame: 3 months ]
  • linear acceleration of practice impacts [ Time Frame: 3 months ]
  • rotational acceleration of practice impacts [ Time Frame: 3 months ]
  • Change in verbal memory composite (ImPACT) scores [ Time Frame: 3 months ]
  • Change in visual memory composite (ImPACT) scores [ Time Frame: 3 months ]
  • Change in visual motor speed composite (ImPACT) scores [ Time Frame: 3 months ]
  • Change in reaction time composite (ImPACT) scores [ Time Frame: 3 months ]
  • Change in Flanker Task (NIH Toolbox) Scores [ Time Frame: 3 months ]
  • Change in pattern comparison (NIH Toolbox) Scores [ Time Frame: 3 months ]
  • Change in list sorting (NIH Toolbox) Scores [ Time Frame: 3 months ]
  • Change in Postural Control Scores [ Time Frame: 3 months ]
  • Change in Conners' Continuous Performance Test (CPT) Scores [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Jillian Urban, PhD, MPH

602-809-0824jurban@wakehealth.edu

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Jillian Urban, PhD, MPH

602-809-0824jurban@wakehealth.edu

Principal Investigator:

Jillian Urban, PhD, MPH

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Sep 10, 2025

Last verified

Sep, 2025

Keywords

  • football injuries
  • subconcussive head impacts
  • head impact exposure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2025-09-10.