NCT06624202 · Wake Forest University Health Sciences
COmmunities Aligned to Reduce Concussion and Head Impact Exposure
(COACH)
What this study is about
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.
View original scientific description
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.
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
Total number of head impacts measured during the season in practices - 0-500 impacts
linear acceleration of practice impacts
Time frame: 3 months
Median peak resultant linear acceleration measured during the season in practices - 8-45 g of linear acceleration
rotational acceleration of practice impacts
Time frame: 3 months
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
Change in verbal memory composite (ImPACT) scores
Time frame: 3 months
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.
Change in visual memory composite (ImPACT) scores
Time frame: 3 months
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.
Change in visual motor speed composite (ImPACT) scores
Time frame: 3 months
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.
Change in reaction time composite (ImPACT) scores
Time frame: 3 months
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.
Change in Flanker Task (NIH Toolbox) Scores
Time frame: 3 months
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.
Change in pattern comparison (NIH Toolbox) Scores
Time frame: 3 months
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.
Change in list sorting (NIH Toolbox) Scores
Time frame: 3 months
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.
Change in Postural Control Scores
Time frame: 3 months
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.
Change in Conners' Continuous Performance Test (CPT) Scores
Time frame: 3 months
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
Where
- Winston-Salem, North Carolina
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 10, 2025 · Source of record for eligibility and locations