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

Wake Forest University (WFU)

Status: Completed

Conditions: Head Injury; Sport Injury

Treatments: Behavioral: practice structure intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06368050

IRB00067187.2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 11 to 14 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

No Intervention

No Intervention group

Description:

Unexposed practice group

Experimental - practice structure intervention

Experimental group

Description:

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.

Treatment:

Behavioral: practice structure intervention