Clinical trial NCT06368050: Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football
Official title: Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Injury
Sport Injury
Keywords: Sport Safety
Youth Football
Head Impact Exposure
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Childress Institute
First posted: 2024-04-16
Enrollment: 34
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of practice head impacts
timeFrame: Month 3
measure: Number of practice head acceleration events
timeFrame: Month 3
measure: Practice head impact rate
timeFrame: Month 3
measure: Practice head acceleration even rate
timeFrame: Month 3
measure: Median linear acceleration
timeFrame: Month 3
measure: Median rotational acceleration
timeFrame: Month 3
measure: Median rotational velocity
timeFrame: Month 3
measure: 95th percentile linear acceleration
timeFrame: Month 3
measure: 95th percentile rotational acceleration
timeFrame: Month 3
measure: 95th percentile rotational velocity
timeFrame: Month 3
Secondary outcomes:
measure: Feasibility of Intervention Measure (FIM) Values
timeFrame: up to 13 weeks
measure: Acceptability of Intervention Measure (AIM) Values
timeFrame: up to 13 weeks
measure: Number of practices the intervention was implemented as prescribed
timeFrame: up to 13 weeks
measure: Average minutes per practice of live time
timeFrame: up to 13 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jill Urban, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: