Clinical trial NCT06624202: COmmunities Aligned to Reduce Concussion and Head Impact Exposure
Official title: COmmunities Aligned to Reduce Concussion and Head Impact Exposure (COACH)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Concussions
Keywords: football injuries
subconcussive head impacts
head impact exposure
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-10-02
Enrollment: 880
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Biomechanical data collection will occur during youth football practices and games.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of practice impacts
timeFrame: 3 months
measure: linear acceleration of practice impacts
timeFrame: 3 months
measure: rotational acceleration of practice impacts
timeFrame: 3 months
measure: Change in verbal memory composite (ImPACT) scores
timeFrame: 3 months
measure: Change in visual memory composite (ImPACT) scores
timeFrame: 3 months
measure: Change in visual motor speed composite (ImPACT) scores
timeFrame: 3 months
measure: Change in reaction time composite (ImPACT) scores
timeFrame: 3 months
measure: Change in Flanker Task (NIH Toolbox) Scores
timeFrame: 3 months
measure: Change in pattern comparison (NIH Toolbox) Scores
timeFrame: 3 months
measure: Change in list sorting (NIH Toolbox) Scores
timeFrame: 3 months
measure: Change in Postural Control Scores
timeFrame: 3 months
measure: Change in Conners' Continuous Performance Test (CPT) Scores
timeFrame: 3 months
Secondary outcomes:
measure: Intervention fidelity percentage of implementation
timeFrame: 3 months
measure: Adaptation of the intervention (AIM) score
timeFrame: pre-season
measure: Feasibility of the Intervention (FIM) score
timeFrame: pre-season
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jillian Urban, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: