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Completed

NCT Number: NCT06368050

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

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.

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Key information

Conditions

Head Injury Craniocerebral Trauma Nervous System Diseases Sport Injury Trauma, Nervous System Wounds and Injuries

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

practice structure intervention

Behavioral

practice structure intervention

Primary outcomes

  1. Number of practice head impacts

    Time frame: Month 3

    Number of verified direct head impacts measured in practice over the entire season.

  2. 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.

  3. Practice head impact rate

    Time frame: Month 3

    Rate of verified direct head impacts per athlete per practice

  4. Practice head acceleration even rate

    Time frame: Month 3

    Rate of verified direct and indirect head acceleration events per athlete per practice

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

Secondary outcomes

  1. Feasibility of Intervention Measure (FIM) Values

    Time frame: up to 13 weeks

    Perceived feasibility - higher values denote better feasibility - total range 0 - 5

  2. Acceptability of Intervention Measure (AIM) Values

    Time frame: up to 13 weeks

    Higher values denote better acceptability - total range 0 - 5

  3. Number of practices the intervention was implemented as prescribed

    Time frame: up to 13 weeks

    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

  4. Average minutes per practice of live time

    Time frame: up to 13 weeks

    Minutes per practice spent on live tackling

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Childress Institute

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 16, 2024
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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