Evidence-based Intervention for Improved Head Impact Safety in Youth Football - Aim 1 and Aim 3

Wake Forest University (WFU)

Status: Completed

Conditions: Head Injury; Sport Injury

Treatments: Behavioral: On-field activity group - Aim 3

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04908930

IRB00067187

K25HD101686 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Two middle school (ages 11-14) football teams will be in Aim 1 of this study. All interested athletes on these teams will be invited to voluntarily participate in biomechanical data collection; of those enrolled, 15-20 per team will be randomly selected for instrumentation with head impact sensors. In aim 3, two youth football teams at the middle school level will be recruited to pilot an intervention developed this study. The football coaches of each team will be prospectively recruited and enrolled. All interested athletes on these teams will be enrolled; of those enrolled, 15-20 per team will be randomly selected for instrumentation with head impact sensors. Baseline and post-season neurocognitive data will be collected.

Full description

This study hypothesizes that (a) determinants at the individual (athlete), interpersonal (team & coach), and community levels (built & social environment) of the social ecological model may be identified and targeted to reduce head impact exposure in youth football practices, and (b) an evidence-based strategy to reduce head impact exposure in practices may be developed and pilot tested using a community-engaged approach.

Enrollment: 106 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: Sequential Assignment

Masking: None (Open label)

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106 participants in 5 patient groups

Unexposed practice group- Aim 1

No Intervention group

Description:

Data from an unexposed sample (football players practicing as they would otherwise).

On-field activity group - Aim 3

Experimental group

Description:

Athletes of two new teams at the middle school level to pilot the practice structure intervention and continuously monitor on-field activity with head impact sensors to evaluate the feasibility, acceptability, and sustainability of the practice structure

Treatment:

Behavioral: On-field activity group - Aim 3

Unexposed practice group- Aim 1 Stakeholders

No Intervention group

Description:

Stakeholders (parents, coaches, league officials) participated in guided discussions using an audit and feedback approach (sharing biomechanical data with the stakeholders) and semi-structured focus groups with the coaches and parents of the participating teams. Also, key informant interviews with league officials were used to assess the awareness and receptivity to creating a safer practice structure.

On-field activity group - Aim 3 Stakeholders

Experimental group

Description:

coaches pilot tested the COACH program

Treatment:

Behavioral: On-field activity group - Aim 3

Unexposed Practice Group - Other Aim Stakeholders

No Intervention group

Description:

Parent and organizational leader stakeholders (unexposed to intervention) participated in guided discussions about safety and biomechanics in youth football