ConcussionsCOACHNCT06624202
COmmunities Aligned to Reduce Concussion and Head Impact Exposure
A study testing COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) Intervention in people with Concussions, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussions
- What is being tested?
- COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants without braces
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Jillian Urban, PhD, MPH, 602-809-0824, Jillian.Hobson@advocatehealth.org
Jillian Urban, PhD, MPH
About this study
Official title: COmmunities Aligned to Reduce Concussion and Head Impact Exposure (COACH)
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.
Read the 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.
- Conditions
- Concussions
- Being tested
- COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) Intervention
- Keywords
- football injuries, subconcussive head impacts, head impact exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| practice intervention | Experimental | 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 Receives: Behavioral: COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of practice impacts
Total number of head impacts measured during the season in practices - 0-500 impacts
Measured: 3 months
linear acceleration of practice impacts
Median peak resultant linear acceleration measured during the season in practices - 8-45 g of linear acceleration
Measured: 3 months
rotational acceleration of practice impacts
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
Measured: 3 months
Change in verbal memory composite (ImPACT) scores
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.
Measured: 3 months
Change in visual memory composite (ImPACT) scores
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.
Measured: 3 months
Change in visual motor speed composite (ImPACT) scores
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.
Measured: 3 months
Change in reaction time composite (ImPACT) scores
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.
Measured: 3 months
Change in Flanker Task (NIH Toolbox) Scores
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.
Measured: 3 months
Change in pattern comparison (NIH Toolbox) Scores
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.
Measured: 3 months
Change in list sorting (NIH Toolbox) Scores
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.
Measured: 3 months
Change in Postural Control Scores
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.
Measured: 3 months
Change in Conners' Continuous Performance Test (CPT) Scores
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
Measured: 3 months
Secondary outcomes (3)
Intervention fidelity percentage of implementation
Implementation score representing the percentage of practices the intervention was implemented as prescribed - 0-100% - higher percent denoting more implementation
Measured: 3 months
Adaptation of the intervention (AIM) score
5-point Likert scale of the acceptability of the intervention - 0-5 - higher scores denoting more adaptation
Measured: pre-season
Feasibility of the Intervention (FIM) score
5-point Likert scale of the feasibility of the intervention - 0-5 - higher scores denoting higher feasibility
Measured: pre-season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start10 May 2025
- Primary completionNov 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Biomechanical data collection will occur during youth football practices and games.
- Masking
- None (open label)
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Jillian Urban, PhD, MPH, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624202
- Sponsor's protocol ID
- IRB00119368
- Other IDs
- R01HD116966
- Acronym
- COACH
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data that underlie the primary outcomes reported in papers after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmmunities Aligned to Reduce Concussion and Head Impact Exposure (COACH)
- ClinicalTrials.gov ID
- NCT06624202
- Acronym / sponsor ID
- COACH / IRB00119368
- Conditions
- Concussions
- Keywords
- football injuries, subconcussive head impacts, head impact exposure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 10 May 2025 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Biomechanical data collection will occur during youth football practices and games.
| Arm | Type | Receives |
|---|---|---|
| practice intervention | Experimental | Behavioral: COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) Interventionhead impact outcomes will be monitored from athletes enrolled on teams participating in the COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) intervention |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants without braces
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) InterventionCOmmunities 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. | Behavioural | practice intervention |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Yes. Participant data that underlie the primary outcomes reported in papers after deidentification
Related trials for Concussions
RecruitingObservational study
The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls
REM Sleep Behavior Disorder, Concussion, Brain
Active, not recruitingObservational study
ATI Evidence-based Guide Investigating Medical and Preventative Services
Sport Medicine
Not yet recruiting
Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury
Concussions, Mild Traumatic Brain Injury, Concussion
Not yet recruiting
Female Concussion Head Cooling
Concussion (Diagnosis), Concussion Post Syndrome
Enrolling by invitationObservational study
Harmonization and Implementation of Sports-related Concussion Guidelines in European Football for Youth - the Erasmus + Project
Sports-related Concussion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jillian Urban, PhD, MPH principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) Intervention in people with Concussions, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jillian Urban, PhD, MPH (602-809-0824, Jillian.Hobson@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of practice impacts (time frame: 3 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.