Head InjuryNCT06368050
Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football
A study testing practice structure intervention in people with Head Injury and Sport Injury, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The objective of this study is to evaluate the feasibility of implementing an evidence-based intervention program, COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) on a larger scale. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Head Injury, Sport Injury
- What is being tested?
- practice structure intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2024to 9 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All athletes participating on the prospective teams will be eligible for the study, including those with braces longer than 6 months
Who cannot join
- Athletes will be excluded from participation if they have had braces less than 6 months, 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.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
The objective of this study is to evaluate the feasibility of implementing an evidence-based intervention program, COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) on a larger scale. Coaches of 12U (12 years old and under), and 13U (13 years old and under) teams within six youth football organizations will pilot test the intervention. Aim 1 will conduct focus groups with coaches, parents, and organizational leaders to assess organizational needs, capacity, and readiness to adopt the intervention program. Aim 2 will evaluate the effectiveness of the intervention program at reducing HIE and injuries and evaluate implementation success. Aim 2 results (intervention outcomes) are reported herein.
Read the detailed description
Coaches of teams at the 12U and 13U levels within the six youth football organizations will be invited to pilot test the intervention program. Intervention outcomes will be compared to historic controls (K25HD101686 - NCT04908930). Video taken at all practices will be used to monitor team activities of 12U and 13U teams across all organizations participating in the intervention; incidence of injuries will be monitored across all teams. Athletes (n=30) enrolled across two of six participating teams will be recruited to participate in parallel biomechanical and video data collection to evaluate the frequency and severity of head impacts experienced throughout the season. Biomechanical data will be collected using instrumented mouth guards and verified with video. Preliminary effectiveness will be measured by the percentage of coaches who choose to adopt and maintain the intervention program. Head impact exposure and injury rates will be compared across the intervention and control teams.
- Conditions
- Head Injury, Sport Injury
- Being tested
- practice structure intervention
- Keywords
- Sport Safety, Youth Football, Head Impact Exposure
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
practice structure interventionBehavioural
practice structure intervention
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | No intervention | Unexposed practice group |
| Experimental - practice structure intervention | Experimental | Athletes of teams at the 12U and 13U level pilot testing the intervention program. On-field activity will be monitored with head impact sensors and video to evaluate the effectiveness of the intervention program. Receives: Behavioral: practice structure intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of practice head impacts
Number of verified direct head impacts measured in practice over the entire season.
Measured: Month 3
Number of practice head acceleration events
Number of verified direct and indirect head acceleration events measured in practice over the entire season.
Measured: Month 3
Practice head impact rate
Rate of verified direct head impacts per athlete per practice
Measured: Month 3
Practice head acceleration even rate
Rate of verified direct and indirect head acceleration events per athlete per practice
Measured: Month 3
Median linear acceleration
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median linear acceleration.
Measured: Month 3
Median rotational acceleration
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational acceleration.
Measured: Month 3
Median rotational velocity
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational velocity
Measured: Month 3
95th percentile linear acceleration
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile linear acceleration
Measured: Month 3
95th percentile rotational acceleration
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational acceleration
Measured: Month 3
95th percentile rotational velocity
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational velocity
Measured: Month 3
Secondary outcomes (4)
Feasibility of Intervention Measure (FIM) Values
Perceived feasibility - higher values denote better feasibility - total range 0 - 5
Measured: up to 13 weeks
Acceptability of Intervention Measure (AIM) Values
Higher values denote better acceptability - total range 0 - 5
Measured: up to 13 weeks
Number of practices the intervention was implemented as prescribed
The extent to which the intervention was implemented as prescribed. Descriptive data and inferential statistics will be used. Common themes will be grouped, and qualitative data indexed and charted
Measured: up to 13 weeks
Average minutes per practice of live time
Minutes per practice spent on live tackling
Measured: up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start2 Jul 2024
- Primary completion9 Nov 2024
- Study completion9 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head InjuryStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Childress Institute
- Responsible party
- Sponsor
- Investigators
- Jill Urban, PhD, MPH, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368050
- Sponsor's protocol ID
- IRB00067187.2
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football
- ClinicalTrials.gov ID
- NCT06368050
- Acronym / sponsor ID
- IRB00067187.2
- Conditions
- Head Injury, Sport Injury
- Keywords
- Sport Safety, Youth Football, Head Impact Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Childress Institute
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 9 Nov 2024 (actual)
- Study completion
- 9 Nov 2024 (actual)
- First posted
- 16 Apr 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.
The objective of this study is to evaluate the feasibility of implementing an evidence-based intervention program, COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) on a larger scale. Coaches of 12U (12 years old and under), and 13U (13 years old and under) teams within six youth football organizations will pilot test the intervention. Aim 1 will conduct focus groups with coaches, parents, and organizational leaders to assess organizational needs, capacity, and readiness to adopt the intervention program. Aim 2 will evaluate the effectiveness of the intervention program at reducing HIE and injuries and evaluate implementation success. Aim 2 results (intervention outcomes) are reported herein.
Detailed description
Coaches of teams at the 12U and 13U levels within the six youth football organizations will be invited to pilot test the intervention program. Intervention outcomes will be compared to historic controls (K25HD101686 - NCT04908930). Video taken at all practices will be used to monitor team activities of 12U and 13U teams across all organizations participating in the intervention; incidence of injuries will be monitored across all teams. Athletes (n=30) enrolled across two of six participating teams will be recruited to participate in parallel biomechanical and video data collection to evaluate the frequency and severity of head impacts experienced throughout the season. Biomechanical data will be collected using instrumented mouth guards and verified with video. Preliminary effectiveness will be measured by the percentage of coaches who choose to adopt and maintain the intervention program. Head impact exposure and injury rates will be compared across the intervention and control teams.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention | No intervention | –Unexposed practice group |
| Experimental - practice structure intervention | Experimental | Behavioral: practice structure interventionAthletes of teams at the 12U and 13U level pilot testing the intervention program. On-field activity will be monitored with head impact sensors and video to evaluate the effectiveness of the intervention program. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All athletes participating on the prospective teams will be eligible for the study, including those with braces longer than 6 months
Key exclusion criteria (1 listed)
- Athletes will be excluded from participation if they have had braces less than 6 months, 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 |
|---|---|---|
| practice structure interventionpractice structure intervention | Behavioural | Experimental - practice structure intervention |
Primary outcome
Number of practice head impacts
Time frame: Month 3
Number of verified direct head impacts measured in practice over the entire season.
Number of practice head acceleration events
Time frame: Month 3
Number of verified direct and indirect head acceleration events measured in practice over the entire season.
Practice head impact rate
Time frame: Month 3
Rate of verified direct head impacts per athlete per practice
Practice head acceleration even rate
Time frame: Month 3
Rate of verified direct and indirect head acceleration events per athlete per practice
Median linear acceleration
Time frame: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median linear acceleration.
Median rotational acceleration
Time frame: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational acceleration.
Median rotational velocity
Time frame: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational velocity
95th percentile linear acceleration
Time frame: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile linear acceleration
95th percentile rotational acceleration
Time frame: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational acceleration
95th percentile rotational velocity
Time frame: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational velocity
4 secondary outcomes
Feasibility of Intervention Measure (FIM) Values
Time frame: up to 13 weeks
Acceptability of Intervention Measure (AIM) Values
Time frame: up to 13 weeks
Number of practices the intervention was implemented as prescribed
Time frame: up to 13 weeks
Average minutes per practice of live time
Time frame: up to 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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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. This study is not recruiting at the moment.
Jill 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 practice structure intervention in people with Head Injury and Sport Injury, 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: finished, as of the sponsor's last update on 4 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of practice head impacts (time frame: Month 3). The study lists 10 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 4 Feb 2025.