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OpenTrials
Completed

NCT Number: NCT04908930

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

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.

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Key information

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

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

On-field activity group - Aim 3

Behavioral

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

Primary outcomes

  1. Number of Head Impacts

    Time frame: Month 3

    Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.

  2. Number of Impacts Per Player Per Minute

    Time frame: Month 3

    Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions. Number of impacts per player per minute

  3. Mean Number of Impacts Per Athlete Per Practice

    Time frame: Month 3

    Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.

  4. 95th Percentile Number of Impacts Per Athlete Per Practice

    Time frame: Month 3

    Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.

  5. Median Linear Acceleration (g)

    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 (g)

    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)

    Time frame: Month 3

    Perceived feasibility - higher values denote better feasibility - total range 0 - 5; 1, completely disagree; 5, completely agree - higher scores denote more possibility and agreeability to Intervention

  2. Acceptability of Intervention Measure (AIM)

    Time frame: Month 3

    total range 0 - 5 higher values denote better acceptability of the intervention (higher scores are better)

  3. Percentage of Practices the Intervention Was Implemented as Prescribed

    Time frame: Month 3

    The intervention was prescribed to the North Carolina High School Athletic Association guidelines for contact in football practices, which limits teams to 15 minutes of live action contact per week. The percentage of practices the intervention was implemented as prescribed was monitored. An implementation score of 2 was given for adequate implementation (<15 minutes), 1 was given for partial implementation (<30 minutes), and 0 was given if live action contact exceeded 30 minutes for each practice. The percentage was calculated as the summed score for the season, divided by the maximum possible score across intervention teams.

  4. Number Changes to the Intervention

    Time frame: Month 3

    Adaptations to the intervention will be tracked as the number of changes to the intervention during the football season. Coach initiated adaptions will be tracked via visual observation. Adaptations advised by the stakeholder team will be tracked via meeting notes.

  5. Verbal Memory (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing

    Time frame: Baseline

    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

  6. Visual Memory Composite Score (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing

    Time frame: Baseline

    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

  7. (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score

    Time frame: Baseline

    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

  8. (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score

    Time frame: Baseline

    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

  9. (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score

    Time frame: Baseline

    ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores. Impulse control is a measure of errors on testing and is useful in determining test validity. This score indicates the sum of errors committed during different phases of the test - 0-40; lower scores are better

  10. Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score

    Time frame: Baseline

    Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 70-120; higher scores are better

  11. Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score

    Time frame: Month 3

    Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 70-120; higher scores are better

  12. NIH Toolbox List Sorting Working Memory Test Score

    Time frame: Baseline

    Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - List Sorting Working Memory; the score range is 50-150 - higher scores are better

  13. NIH Toolbox List Sorting Working Memory Test Score

    Time frame: Month 3

    Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - List Sorting Working Memory; the score range is 50-150 - higher scores are better

  14. NIH Toolbox Picture Vocabulary Test Score

    Time frame: Baseline

    Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Vocabulary - 70-120; higher scores are better

  15. NIH Toolbox Picture Sequence Memory Test Score

    Time frame: Baseline and month 3

    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

  16. NIH Toolbox Picture Vocabulary Test Score

    Time frame: Month 3

    Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Vocabulary - 70-120; higher scores are better

  17. Rey Auditory Verbal Learning Test Score (RAVLT)

    Time frame: Baseline

    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 - 0-45; higher scores are better

  18. Rey Auditory Verbal Learning Test Score (RAVLT)

    Time frame: Month 3

    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 - 0-45; higher scores are better

  19. Postural Control - Anterior-Posterior Postural Sway Score

    Time frame: Baseline and month 3

    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

  20. Postural Control - Medial-Lateral Postural Sway Score

    Time frame: Baseline and month 3

    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

  21. Postural Control - Maximum Path Velocity Score

    Time frame: Baseline and month 3

    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

  22. Postural Control - Center of Pressure Area Score

    Time frame: Baseline and month 3

    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

  23. Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits

    Time frame: Baseline

    The participant will be asked to focus on a small target that will be moved horizontally and vertically. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.

  24. Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits

    Time frame: Month 3

    The participant will be asked to focus on a small target that will be moved horizontally and vertically. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.

  25. Vestibular/Ocular Motor Screening (VOMS) - Convergence

    Time frame: Month 3

    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. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.

  26. Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades

    Time frame: Baseline

    The participant will be asked to focus on two small targets that are horizontally aligned, moving their eyes quickly from one target to the other. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.

  27. Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades

    Time frame: Month 3

    The participant will be asked to focus on two small targets that are horizontally aligned, moving their eyes quickly from one target to the other. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.

  28. Vestibular/Ocular Motor Screening (VOMS) - Convergence

    Time frame: Baseline

    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. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.

  29. Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity

    Time frame: Baseline

    The participant will be asked to focus on a small target that they are holding still while rotating their torso from side to side. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.

  30. Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades

    Time frame: Baseline

    The participant will be asked to focus on two small targets that are vertically aligned, moving their eyes quickly from one target to the other. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.

  31. Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades

    Time frame: Month 3

    The participant will be asked to focus on two small targets that are vertically aligned, moving their eyes quickly from one target to the other. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.

  32. Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex

    Time frame: Baseline

    The participant will be asked to focus on one small target while rotating their head from side to side. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.

  33. Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity

    Time frame: Month 3

    The participant will be asked to focus on a small target that they are holding still while rotating their torso from side to side. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.

  34. Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence

    Time frame: Baseline

    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

  35. Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence

    Time frame: Month 3

    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

  36. Conners' Continuous Performance Test (CPT) - Reaction Speed

    Time frame: Baseline

    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; Raw reaction speed is the mean response speed for all non-perseverative responses made during the entire Test. Raw reaction speed is converted to standardized T-scores 0-90; 50 indicates the population mean with a standard deviation of 10. 70+ is atypically slow and <40 is atypically fast. Reaction speed is bi-directional with higher scores indicating slower reaction times (i.e., inattentiveness), and lower scores indicating faster reaction times (i.e., impulsivity)

  37. Conners' Continuous Performance Test (CPT)) - Omissions

    Time frame: Baseline

    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 Omissions; Raw omissions scores are based on the number of missed targets during the test. Raw omissions scores are converted to standardized T-scores 0-90; 50 indicates the population mean with a standard deviation of 10. 70+ is very elevated and indicates poor performance. Higher scores indicate poorer performance

  38. Conners' Continuous Performance Test (CPT) - Omissions

    Time frame: Month 3

    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 Omissions; Raw omissions scores are based on the number of missed targets during the test. Raw omissions scores are converted to standardized T-scores 0-90; 50 indicates the population mean with a standard deviation of 10. 70+ is very elevated and indicates poor performance. Higher scores indicate poorer performance

  39. Conners' Continuous Performance Test (CPT) - Commissions

    Time frame: Baseline

    Participants will complete a 14-minute computerbased 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; Raw commissions are incorrect responses to non-targets. Raw commissions scores are converted to standardized T-scores 0-90; 50 indicates the population mean with a standard deviation of 10. 70+ is very conservative and indicates much emphasis on accuracy over speed and ≤30 is very liberal and indicates much emphasis on speed over accuracy. Scores indicate the nature of participants' response style rather than performance

  40. Conners' Continuous Performance Test (CPT) - Commissions

    Time frame: Month 3

    Participants will complete a 14-minute computerbased 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; Raw commissions are incorrect responses to non-targets. Raw commissions scores are converted to standardized T-scores 0-90; 50 indicates the population mean with a standard deviation of 10. 70+ is very conservative and indicates much emphasis on accuracy over speed and ≤30 is very liberal and indicates much emphasis on speed over accuracy. Scores indicate the nature of participants' response style rather than performance

  41. Conners' Continuous Performance Test (CPT) - Perseverations

    Time frame: Baseline

    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; Raw perseverations are responses that are made in less than 100 milliseconds following a stimulus. Raw perseverations scores are converted to standardized T-scores 0-90; 50 indicates the population mean with a standard deviation of 10. 70+ is very elevated and indicates poor performance. Higher scores indicate poorer performance

  42. Conners' Continuous Performance Test (CPT) - Perseverations

    Time frame: Month 3

    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; Raw perseverations are responses that are made in less than 100 milliseconds following a stimulus. Raw perseverations scores are converted to standardized T-scores 0-90; 50 indicates the population mean with a standard deviation of 10. 70+ is very elevated and indicates poor performance. Higher scores indicate poorer performance

  43. Post Season (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score

    Time frame: Month 3

    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

  44. (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score

    Time frame: Month 3

    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

  45. (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score

    Time frame: Month 3

    ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores. Impulse control is a measure of errors on testing and is useful in determining test validity. This score indicates the sum of errors committed during different phases of the test - 0-40; lower scores are better

  46. NIH Toolbox Pattern Comparison Test Score

    Time frame: Baseline

    The Pattern Comparison Test is a measure of speed of processing, which typically improves steadily (time to complete task decreases) throughout childhood and adolescence, then begins to decline in adulthood, becoming much slower in older adults. As such, it is considered a "fluid ability" measure. Score range: 0-130

  47. NIH Toolbox Pattern Comparison Test Score

    Time frame: Month 3

    The Pattern Comparison Test is a measure of speed of processing, which typically improves steadily (time to complete task decreases) throughout childhood and adolescence, then begins to decline in adulthood, becoming much slower in older adults. As such, it is considered a "fluid ability" measure. Score range: 0-130

  48. (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Verbal Memory Composite Score

    Time frame: Month 3

    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

  49. (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Memory Composite Score

    Time frame: Month 3

    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

  50. Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex

    Time frame: Month 3

    The participant will be asked to focus on one small target while rotating their head from side to side. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.

  51. Conners' Continuous Performance Test (CPT) - Reaction Speed

    Time frame: Month 3

    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; Raw reaction speed is the mean response speed for all non-perseverative responses made during the entire Test. Raw reaction speed is converted to standardized T-scores 0-90; 50 indicates the population mean with a standard deviation of 10. 70+ is atypically slow and <40 is atypically fast. Reaction speed is bi-directional with higher scores indicating slower reaction times (i.e., inattentiveness), and lower scores indicating faster reaction times (i.e., impulsivity).

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Community-Engaged Sport Safety - Aim 1 and Aim 3

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2021
Registry last updated
Feb 27, 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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