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Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football

Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06368050
Enrollment
34
Registered
2024-04-16
Start date
2024-07-02
Completion date
2024-11-09
Last updated
2025-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Injury, Sport Injury

Keywords

Sport Safety, Youth Football, Head Impact Exposure

Brief 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. 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.

Interventions

BEHAVIORALpractice structure intervention

practice structure intervention

Sponsors

Childress Institute
CollaboratorUNKNOWN
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 14 Years
Healthy volunteers
Yes

Inclusion criteria

* All athletes participating on the prospective teams will be eligible for the study, including those with braces longer than 6 months

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
95th percentile rotational velocityMonth 3Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational velocity
Median rotational accelerationMonth 3Head 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 velocityMonth 3Head 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 accelerationMonth 3Head 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 accelerationMonth 3Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational acceleration
Number of practice head impactsMonth 3Number of verified direct head impacts measured in practice over the entire season.
Number of practice head acceleration eventsMonth 3Number of verified direct and indirect head acceleration events measured in practice over the entire season.
Practice head impact rateMonth 3Rate of verified direct head impacts per athlete per practice
Practice head acceleration even rateMonth 3Rate of verified direct and indirect head acceleration events per athlete per practice
Median linear accelerationMonth 3Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median linear acceleration.

Secondary

MeasureTime frameDescription
Acceptability of Intervention Measure (AIM) Valuesup to 13 weeksHigher values denote better acceptability - total range 0 - 5
Number of practices the intervention was implemented as prescribedup to 13 weeksThe 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
Average minutes per practice of live timeup to 13 weeksMinutes per practice spent on live tackling
Feasibility of Intervention Measure (FIM) Valuesup to 13 weeksPerceived feasibility - higher values denote better feasibility - total range 0 - 5

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026