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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Community-Engaged Sport Safety - Aim 1 and Aim 3

Conditions
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Head Injury, Sport Injury

Intervention / Treatment
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* Behavioral: On-field activity group - Aim 3


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: All interested football players on the 2 teams will be enrolled; of those enrolled, 15-20 per team (n=30-40 total) will be randomly selected for instrumentation with head impact sensors using a random numbers table. Athletes on these teams will follow their coach prescribed practice structure. Two additional youth football teams at the middle school level will be recruited to pilot test the intervention developed in this study. All interested athletes on these teams will be enrolled; of those enrolled, 15-20 per team (n=30-40 total) will be randomly selected for instrumentation with head impact sensors using a random numbers table. Enrolled athletes will wear head impact sensors embedded in a custom mouthpiece that will be used to collect head impact exposure in conjunction with on-field video data for the season.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Unexposed practice group- Aim 1<br>Data from an unexposed sample (football players practicing as they would otherwise). | |
| Experimental: On-field activity group - Aim 3<br>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 | Behavioral: On-field activity group - Aim 3<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Head Impacts | Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions. | Month 3 | 
| Impact rate | Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions. | Month 3 | 
| Mean number of impacts | Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions. | Month 3 | 
| 95th percentile number of impacts | Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions. | Month 3 | 
| Median linear acceleration | Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median linear acceleration. | Month 3 | 
| Median rotational acceleration | Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational acceleration. | Month 3 | 
| Median rotational velocity | Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational velocity. | Month 3 | 
| 95th percentile linear acceleration | 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. | Month 3 | 
| 95th percentile rotational acceleration | 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. | Month 3 | 
| 95th percentile rotational velocity | 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. | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Intervention Measure (FIM) | Perceived feasibility - higher values denote better feasibility - total range 0 - 5 | Fall season, up to 13 weeks | 
| Acceptability of Intervention Measure (AIM) | Higher values denote better acceptability - total range 0 - 5 | Fall season, up to 13 weeks | 
| Number of times the intervention was implemented as prescribed | 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. | Fall season, up to 13 weeks | 
| Number changes to the intervention | Descriptive data and inferential statistics will be used. Common themes will be grouped, and qualitative data indexed and charted. | Fall season, up to 13 weeks | 
| (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Verbal Memory Composite Score | ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-100; higher scores are better | Baseline and month 3 | 
| (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Memory Composite Score | ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-100; higher scores are better | Baseline and month 3 | 
| (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score | ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-100; higher scores are better | Baseline and month 3 | 
| (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score | ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-1; lower scores are better | Baseline and month 3 | 
| (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score | ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-40; lower scores are better | Baseline and month 3 | 
| Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score | Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 70-120; higher scores are better | Baseline and month 3 | 
| NIH Toolbox List Sorting Working Memory Test Score | Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Sequence Memory - 70-120; higher scores are better | Baseline and month 3 | 
| NIH Toolbox Picture Vocabulary Test Score | Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Vocabulary - 70-120; higher scores are better | Baseline and month 3 | 
| NIH Toolbox Picture Sequence Memory Test Score | Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Sequence Memory - 70-120; higher scores are better | Baseline and month 3 | 
| Rey Auditory Verbal Learning Test Score (RAVLT) | The RAVLT assesses verbal learning ability - A series of 15 words is presented to the participant 3 times via audio recording for standardization, and answers are recorded - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-15; higher scores are better | Baseline and month 3 | 
| Postural Control - Anterior-Posterior Postural Sway Score | Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-50; lower scores are better | Baseline and month 3 | 
| Postural Control - Medial-Lateral Postural Sway Score | Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-50; lower scores are better | Baseline and month 3 | 
| Postural Control - Maximum Path Velocity Score | Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-10; lower scores are better | Baseline and month 3 | 
| Postural Control - Center of Pressure Area Score | Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-20; lower scores are better | Baseline and month 3 | 
| Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits | The participant will be asked to focus on a small target and slowly bring it to the tip of their nose until two distinct images of the target are seen. The participant will complete this three times and scores will be averaged over three trials - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Rates changes in symptoms on 0 - 10; lower scores are better | Baseline and month 3 | 
| Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades | The participant will be asked to focus on a small target and slowly bring it to the tip of their nose until two distinct images of the target are seen. The participant will complete this three times and scores will be averaged over three trials - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Rates changes in symptoms on 0 - 10; lower scores are better | Baseline and month 3 | 
| Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades | The participant will be asked to focus on a small target and slowly bring it to the tip of their nose until two distinct images of the target are seen. The participant will complete this three times and scores will be averaged over three trials - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Rates changes in symptoms on 0 - 10; lower scores are better | Baseline and month 3 | 
| Vestibular/Ocular Motor Screening (VOMS) - Convergence | The participant will be asked to focus on a small target and slowly bring it to the tip of their nose until two distinct images of the target are seen. The participant will complete this three times and scores will be averaged over three trials - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Rates changes in symptoms on 0 - 10; lower scores are better | Baseline and month 3 | 
| Vestibular/Ocular Motor Screening (VOMS) - Horizontal vestibular ocular reflex | The participant will be asked to focus on a small target and slowly bring it to the tip of their nose until two distinct images of the target are seen. The participant will complete this three times and scores will be averaged over three trials - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Rates changes in symptoms on 0 - 10; lower scores are better | Baseline and month 3 | 
| Vestibular/Ocular Motor Screening (VOMS) - Visual motion sensitivity | The participant will be asked to focus on a small target and slowly bring it to the tip of their nose until two distinct images of the target are seen. The participant will complete this three times and scores will be averaged over three trials - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Rates changes in symptoms on 0 - 10; lower scores are better | Baseline and month 3 | 
| Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence | The participant will be asked to focus on a small target and slowly bring it to the tip of their nose until two distinct images of the target are seen. The participant will complete this three times and scores will be averaged over three trials - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Rates changes in symptoms on 0 - 15; lower scores are better | Baseline and month 3 | 
| Conners' Continuous Performance Test (CPT) - Reaction Speed | Participants will complete a 14-minute computer-based assessment that evaluates selective, sustained and divided attention, as well as impulsivity and vigilance - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - CPT Reaction Speed T score; 0-100; lower scores are better | Baseline and month 3 | 
| Conners' Continuous Performance Test (CPT) - Omissions | Participants will complete a 14-minute computer-based assessment that evaluates selective, sustained and divided attention, as well as impulsivity and vigilance - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - CPT Ommissions T score; 0-100; lower scores are better | Baseline and month 3 | 
| Conners' Continuous Performance Test (CPT) - Commissions | Participants will complete a 14-minute computer-based assessment that evaluates selective, sustained and divided attention, as well as impulsivity and vigilance - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - CPT Commission T score; 0-100; lower scores are better | Baseline and month 3 | 
| Conners' Continuous Performance Test (CPT) - Perseverations | Participants will complete a 14-minute computer-based assessment that evaluates selective, sustained and divided attention, as well as impulsivity and vigilance - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - CPT Perseverations T score; 0-100; lower scores are better | Baseline and month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sport Safety, Youth Football, Head Impact Exposure