COmmunities Aligned to Reduce Concussion and Head Impact Exposure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) Intervention.
- Who it may be relevant to
- Registry conditions: Concussions. Basic parameters: 11 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
COmmunities Aligned to Reduce Concussion and Head Impact Exposure (COACH)
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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]
Secondary outcome measures (3)
- Intervention fidelity percentage of implementation [Time frame: 3 months]
- Adaptation of the intervention (AIM) score [Time frame: pre-season]
- Feasibility of the Intervention (FIM) score [Time frame: pre-season]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Wake Forest University Health Sciences — Winston-Salem
Identifiers
NCT: NCT06624202 · IRB00119368 · R01HD116966