COACH Intervention for Youth Football Concussion Prevention
This study is testing a safety program called "COmmunities Aligned to reduce Concussion and Head impact exposure (COACH)" for youth football players. The COACH program uses special practice plans and a resource booklet based on high school guidelines to help coaches plan safer practices and reduce head impacts. Researchers want to see if COACH can reduce the number and force of head impacts during practice. They will measure the number, linear acceleration (straight-line force), and rotational acceleration (twisting force) of head impacts over three months. This study is for boys and girls aged 11 to 14 years who do not have braces or other dental appliances that would interfere with a mouthpiece device. The current status of this study is unclear, and it plans to enroll 880 participants.
- Study design
- This is an interventional study with a planned enrollment of 880 participants. It is not specified if it is randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints, which measure head impacts, will be assessed at 3 months.
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COmmunities Aligned to Reduce Concussion and Head Impact Exposure
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jillian Urban, PhD, MPH · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Number of practice impacts3 months
Total number of head impacts measured during the season in practices - 0-500 impacts
- linear acceleration of practice impacts3 months
Median peak resultant linear acceleration measured during the season in practices - 8-45 g of linear acceleration
- rotational acceleration of practice impacts3 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) scores3 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) scores3 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) scores3 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) scores3 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) Scores3 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) Scores3 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) Scores3 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 Scores3 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) Scores3 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