Community-Engaged Sport Safety - Aim 1 and Aim 3
Phase: NA
Conditions: Head Injury, Sport Injury
Sponsor: Wake Forest University Health Sciences

Community-Engaged Sport Safety
IRB00067187 
NCT04908930
IRB Approval Date:  21AUG2024

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Instructions and Notes 
Study Title: Community-Engaged Sport Safety 
Principal Investigator, Co-investigator(s): 
Jillian Urban, PhD, MPH 
Sponsor or funding source: NIH 
Background, Rationale and Context 
Football has one of the highest rates of concussion among youth team sports.1,2 Although 
concussions are common in football, subconcussive head impacts, or repetitive head impacts without signs 
and symptoms of concussion, are a rising concern.3–8 Recent studies have begun to study characteristics of 
subconcussive head impacts.9–11 Exposure to cumulative head impact exposure (i.e., the frequency and 
magnitude of hits) resulting from participation in football (as well as other contact and collision sports) may 
result in long term sequelae.3–8,12–14 Indeed, neuroimaging findings demonstrate a potential cumulative 
effect of head impact exposure on the brain after a single season.15–32 However, some studies have failed 
to demonstrate a strong and consistent relationship between participation in football and cognitive change 
after a single season.33–38 The association between pre-high school participation in contact and collision 
sports and later-life neurodegeneration or neurocognitive deficits is also not well-understood.3,4,39–44 
However, one critical missing component of many prior investigations is high-quality data on head impact 
exposure. This literature motivates the collection of biomechanical data from head impact sensors to 
understand exposure and clinical implications of those impacts as to identify solutions to mitigate head 
impacts in sport. 
Youth football organizations often organize players into levels of play by age, or by age and weight. 
Changes in body size (height and weight) and physical performance (speed, power, endurance) occur in 
parallel with adolescent participation in youth football, but can occur at different rates.45–47 It is thought 
that older athletes are faster, stronger and may play more aggressively than their younger counterparts.45,48–
50 We recently published a study that found youth football players with higher pre-season physical 
performance measures on drills had higher head impact exposure, especially in games.51 Head impact 
magnitude is often summarized by the peak resultant linear and rotational acceleration of the head resulting 
from each hit. A recent study of youth hockey players found that less aggressive players had significantly 
lower rotational accelerations than more aggressive players during practice.52 Lastly, underreporting of 
concussions has historically been a challenge.53,54 Improving knowledge, attitudes, and beliefs may 
improve reporting and perspectives related to concussion,55,56 and may also influence norms associated 
with high risk behaviors on-field. In this study, we will evaluate the feasibility and appropriateness of 
targeting individual-level determinants (e.g. knowledge, attitudes, beliefs) to reduce head impact exposure 
in youth football. 
The first study evaluating head impact exposure in youth football demonstrated that most high-
level impacts (> 80g) occur during practices, not games.57 This result led to rule changes implemented by 
the Pop Warner League (~9-11% of youth football participants in the US), limiting how much contact (i.e., 
full-speed drills or scrimmages) a team has and eliminating full speed head-on blocking and tackling 
drills.58 Our group found that limiting time spent on contact in practices resulted in 37-46% fewer head 
impacts in a season in a youth football team that implemented these rule changes versus two teams that did 
not;59 however, this result has not been tested in other youth teams. Broglio et al. observed an average of 
42% fewer impacts per player following a statewide restriction on full-contact high school practices.60 I 
recently led a study that demonstrated that simply reducing time spent in contact may not decrease head 
impact exposure – contact quality or intensity may be more important, a finding later substantiated by 
Stemper et al.61 62 Increasing head impact exposure is associated with level of play (i.e., youth, high school); 

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however, wide variability in the number and magnitude of head impacts occurs within each level of 
play.9,11,57,59,63 Nearly two-thirds of the head impacts a youth football player receives in a single season 
occur in practice9,11,57,59 and head impact exposure during the season is influenced by activities such as the 
drills conducted as a team.59,64 Mechanics of tackling may also affect head impact exposure,64–68 and a 
recent study showed that incorporating targeted drills into a team’s practice resulted in improved tackling 
technique and reduced head impact exposure.69 This study will use combined biomechanics and video to 
assess and inform attitudes and perceptions of stakeholders surrounding head impact exposure in football 
and explore multi-level determinants that may be targeted to reduce exposure.  
Implementation science and community engagement approaches have not been applied to youth 
sports.70–76 Community engagement joins community members and researchers to establish and sustain 
partnerships throughout the research process to build trust, create better communication, and improve health 
outcomes through action-oriented efforts.72,77,78 Community-level interventions address access to 
resources, the built (i.e., structure) and social (i.e., relationships within the community) environment, and 
cultural norms of a community.79 Youth football leagues are often community-run organizations with 
limited resources and coaching support from parent volunteers. To develop relevant interventions to 
improve sport safety, it is critical to design innovative methods to translate research findings into practical 
strategies likely to be well received by the youth football community. Dissemination of research findings 
is also a critical step toward making successful interventions a lasting “legacy”.80 In this study, we will 
create partnerships in the local community, identify and engage key stakeholders, and develop a model that 
may be expanded to other youth sports.  
 
Objectives 
Whether repetitive head impacts sustained in contact sports such as football lead to structural and functional 
brain changes is a matter of debate. Nevertheless, changes in the brain over a single season of youth and 
high school football and later in life have been documented.3–8,17,20,22–24,28,32,81,82 With about 2.8-3.5 
million athletes between the ages of 6 and 13 participating in youth football each year, there is a critical 
need to reduce head impact exposure.57,83 Several youth organizations have implemented rule changes to 
reduce contact and concussion risk; however, these rules are not informed by evidence in youth football. 
Additionally, the most effective targets for reducing head impact exposure and concussion risk and how 
best to implement change in this setting is unknown. The objective of this study is to develop and pilot test 
an evidence-based intervention to reduce head impact exposure in youth football practices using a 
community-engaged approach. We will seek to address the following specific aims:  
 
Aim 1: Determine the awareness and receptivity to creating a safer practice structure to reduce head 
impact exposure in youth football among key stakeholders. 
 
Aim 2: Develop an evidence-based intervention to reduce head impact exposure in youth football 
practices, using a community-engaged approach. 
 
Aim 3: Pilot-test the evidence-based practice structure to reduce head impact exposure and mitigate 
changes in clinical outcomes in youth football. 
 
We hypothesize that (a) determinants at the individual (athlete), interpersonal (team & coach), and 
community levels (built & social environment) of the social ecological model84 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. (c) The reduction in exposure will be associated with a lower rate of change in pre- to post-season 
clinical outcome measures and cognitive function scores.  
 
 

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Methods and Measures 
 
Design 
Two local youth football teams at the middle school level (ages 11-14) will be recruited to 
participate in this study. Informed consent and signed assent forms will be obtained from 
parents/legal guardians of participating youth football players. 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. Head impact 
sensors embedded in a custom mouthpiece will be used to collect head impact exposure in 
conjunction with on-field video data for a season. These data will be used to inform guided 
discussions with stakeholders (parents, coaches, league officials). Using an audit and feedback 
approach (sharing biomechanical data with the stakeholders), we will facilitate semi-structured 
focus groups with the coaches (n=8) and parents (n=10) of the participating teams, and key 
informant interviews with league officials (n=8), to assess the awareness and receptivity to creating 
a safer practice structure. Participants will be asked to complete a series of cognitive, 
vestibular/ocular motor, and postural stability tasks pre- and post-season. 
 
An anonymous survey concerning knowledge, attitudes, and practices as well as the perceived 
needs, perceived benefits, capacity, and barriers to implementing efforts to improve head impact 
safety will be created and sent to coaches, parents, and league officials (n=153). Data will be 
combined with published literature to inform the development of an evidence-based intervention 
using a community-engaged approach. At the end of year 3, two youth football teams at the middle 
school level will be recruited to pilot test the intervention developed in this study. The football 
coaches of each team will be prospectively recruited and enrolled. Informed consent will be 
obtained from adults (coaches and parents/legal guardians of youth athletes) and parents/legal 
guardians of all participating youth athletes will sign assent forms. Again, 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. Athletes will 
also complete the series of cognitive, vestibular/ocular motor, and postural stability tasks pre- and 
post-season. On-field activity, skills, and behaviors will be monitored with head impact sensors 
and on-field video data to evaluate the effectiveness of the intervention at reducing head impact 
exposure and the acceptability, feasibility, and fidelity of the intervention.  The results will be 
disseminated to the youth football league at the end of the study.  
 
Setting 
Biomechanical data collection will occur during youth football practices and games. Stakeholder 
meetings and key informant interviews will be conducted at the local elementary school, 
community centers, and Biotech Place in Winston Salem, NC. Clinical outcome data collection and 
data analysis will be conducted at the WFU Center for Injury Biomechanics, a research lab located 
at Biotech Place. Additionally, we plan to recruit individuals across the Piedmont Triad and 
Charlotte Mecklenburg regions in Fall 2024 data collection. 
 
Subjects selection criteria 
• 
Inclusion Criteria 
Mouthpiece and Clinical Outcome Data Collection:  
All athletes participating on the prospective teams will be eligible for the study, including those 
with braces longer than 6 months.  
 

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Focus Groups, Key Informant Interviews:  
All parents with athletes participating on the prospective teams and coaches of the prospective 
teams will be eligible for participation in the study.  All league officials of the governing 
organization will be eligible for participation in the study.  
 
Surveys:  
All parents, coaches, and league officials of the governing youth football organization will be 
eligible for participation in the survey portion of the study.  
 
• 
Exclusion Criteria 
Mouthpiece and Clinical Outcome Data Collection:  
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).   
 
• 
Sample Size 
Study Sample - Athletes: Each year of the study, we will identify two middle school (ages 11-
14) football teams for 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. Informed consent will be 
obtained from parents/legal guardians of all athletes; participating athletes will sign assent 
forms. The number of athletes (N=30-40 each year, N=105-130 total) was chosen based on our 
earlier studies, which reported significant differences in exposures among football conditions 
with sample sizes of 985, 4086 and 3087. We aim to accrue sufficient information to assess 
relationships (e.g. between measures of exposures) and describe variability among exposure 
levels among conditions and athletes. N=30 provides >80% power to detect correlations of 
r>=0.50, i.e. associations of sufficient strength to inform design of the intervention (Aim 3). It 
also provides sufficient precision for estimating standard deviations: 90% confidence intervals 
will range from 0.83 to 1.28 SD units. Additionally, a Fall 2022 football cohort (N=14) from 
Head Kinematics in Sports Study (IRB00049715) will be included in biomechanics data 
collection and analysis. In Fall 2024, we plan to enroll (n=55) athletes across two of six 
participating teams to participate in parallel biomechanical and video data collection to evaluate 
the frequency and severity of head impacts experienced throughout the season. 
 
Study Sample - Stakeholders: Coaches and parents of the participating teams will be recruited 
to participate in separate focus groups—two for coaches and two for parents. League officials 
will be prospectively recruited to participate in key informant interviews. Informed consent 
will be obtained from stakeholders. Each team has one head coach and three to five assistant 
coaches and approximately 20 athletes. The number of parents (n=40) and coaches (n=35) 
enrolled in the focus group portion of this study was selected based on the estimated number 
of athletes (and thus number of parents) and coaches involved with each football team. We 
expect to recruit 25% of the parents and 100% of the coaches participating on each team. Only 
one parent per family will be asked to participate to increase the number of families able to 
participate in discussions. We expect to enroll one-third (n=8) of league officials to participate 
in key informant interviews.  
 
Study Sample - Surveys: An anonymous survey (7-10 minutes) will be created and sent via 
email listserv to coaches, parents, and league officials of the local youth football league at the 
start of the fall football season There are ~150 football coaches of 51 football teams 
participating in one of 12 organizations, with ~800 families, and 24 league officials. To obtain 
a representative sample, we will seek a sample size of N=25 coaches (16.7%), N=120 parents 
(15%), and N=8 league officials (33%). 

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Interventions and Interactions 
 
Biomechanics Data Collection:  
We will conduct biomechanical data collection from athletes participating on local youth football 
teams. A custom mouthpiece will be created for each athlete participating in this study. The custom 
mouthpiece is made of acrylic material, which is a commonly used biocompatible material used to 
make dental retainers. An accelerometer, gyroscope, inductive charging coil, processor, and 
batteries are embedded in the mouthpiece. The mouthpiece is worn by the subject on the upper 
dentition and a soft mouthpiece overlay may be adhered to the mouthpiece. Data from 
accelerometer and gyroscopes are stored in the device and downloaded after a data collection event. 
Each athlete will be custom fit to a mouthpiece by having an intraoral scan (TRIOS, Copenhagen, 
Denmark) of the upper dentition by a trained dental technician. The scan obtains a high-resolution 
3-D model used for printing using a Carbon M1 3D printer with Continuous Light Interphase 
Production. The dental scan is a resolution three-dimensional picture reconstructed from thousands 
of 2D pictures collected of the teeth.  The scan takes approximately 4 minutes to obtain. These will 
be obtained using a standard procedure performed by a dentist or by a dental technician / hygienist 
overseen by a dentist. The 3-D printed model is used to create the custom mouthpiece for each 
individual. 
 
The mouthpiece with sensor will be individually assigned to each participant and will be distributed 
before each data collection event by study staff. The mouthpiece with sensor will be collected after 
each data collection event. The distribution and collection of the sensor system with mouthpiece 
will occur before and after data collection events so minimal time or action will be required on the 
part of the participants. The mouthpieces will be individually cleaned and stored in a sanitary 
manner such that contamination between athlete mouthpieces is avoided. 
 
The custom mouthpiece device is made of the same material as dental retainers currently worn in 
the target populations. These devices are observational devices. The risks of wearing the 
instrumented mouthpiece are low due to the low total power of the battery used (3.7V, 30mAh) and 
all electronics and battery will be encapsulated in medical-grade acrylic as a moisture and dielectric 
barrier. Collaborating researchers at Wake Forest and Virginia Tech have performed pilot studies 
approved by the respective Institutional Review Board (IRB) with this device and none of the 
athletes have reported adverse events from wearing the mouthpiece to the research team.  
 
The mouthguard form of the mouthpiece is made of medical-grade acylic and elastomer polymer 
mouthguard material (ethylene vinyl acetate). The acrylic and mouthguard material are held 
together with a form of super glue (ethyl cyanoacrylate). These type of materials have been used in 
dental applications and preliminary evidence suggests that they are safe for intraoral use [or for use 
within the mouth].   
 
The Prevent mouthguard is made of USP Class VI (medical grade) or FDA food grade 
thermoplastic mouthguard material (polyurethane and ethylene vinyl acetate). The iMG complies 
with CE requirements and FCC regulations for wireless communication. These type of materials 
have been used in dental applications and preliminary evidence suggests that they are safe for 
intraoral use [or for use within the mouth].   
 
Another team we will follow in the Fall 2024 season will wear a helmet sensor. The sensor measures 
the motion of his/her head when your child has been hit. The CUE Sport Sensor is a helmet or 
headband wearable sensing technology designed to collect key data on the head-impacts our 
athletes sustain. When paired with the Athlete Intelligence system, they analyze on-field head-

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impacts from each game and practice. The data is downloaded off the sensors using a mobile phone 
and sent to our secure cloud-based system to analyze team, position, and athlete impact profiles 
while identifying training opportunities based on the data collect to improve the safety and 
performance of each athlete. Because this is a system designed for the coach as the end user, the 
coach of the team will receive reports related head impacts of athletes to inform safety and 
performance. 
 
Participants in this study will be asked to provide consent to collect on-field video footage for the 
purpose of this study. Videotapes, audiotapes, and/or photographs will be used for presentation 
purposes and/or for visualization of a specific impact or play to guide focus group discussions.  The 
context of the events leading up to and the events following an impact may be relevant to the 
study. In any use of this photograph/videotape/audiotape, the subjects name will not be identified. 
To protect individuals further, individual’s impacts will not be discussed during focus group 
meetings but rather summary statistics represented a collection of events measured by the 
mouthpieces. During the consent process, the athletes and parents will be made clear that the 
biomechanical data and matched video collected in this study will be used to guide focus group 
discussions.  
 
Stakeholder Survey:  
An anonymous survey will be sent via email listserv to coaches, parents, and league officials of the 
local youth football league at the start of the fall football season. Survey questions will be derived 
from previously published surveys and guided by constructs of a published health behavior model. 
Where appropriate, responses will be made optional. A cover letter will state that completion of the 
survey indicates consent to participate. Parents will only complete the survey once, even if they 
have multiple children participating in football. League officials and coaches will also be asked to 
complete an additional survey (Organizational Readiness for Implementing Change (ORIC)). An 
anonymous survey will be sent via email listserv to coaches of local youth football leagues and 
high schools. Survey questions will be derived from previously published surveys.  Data collection 
will be open one month prior to and during the first month of the football season. We will work 
with the league to reach as many respondents as possible. To encourage participation, those who 
complete the survey within the first month of the season will be entered into a raffle to win one of 
three $50 gift cards.  Email address will be stored separate from the survey response only for the 
purpose of notifying of the raffle result in order to maintain anonymity of survey responses.  
 
Focus Groups:  
During the football season, coaches (n=8, 4 from each team) and parents (n=10, 5 from each team) 
of the enrolled teams will be invited to participate in separate 60-minute focus groups (two for 
coaches, two for parents) monthly (Aug, Sept, Oct, Nov), using an audit and feedback approach. 
At the first (Aug) and last meeting (Nov), coaches and parents will complete the stakeholder survey 
(Appendix 2). Coaches will also complete a 10-question survey assessing how often the coaches 
include specific drills in their practice structure and the perceived frequency and magnitude of hits 
experienced in five common youth football drills: Install, Oklahoma, One-on-One, Open Field 
Tackling, and Position Skill Work. Sample questions include: “On a scale of 0 to 6, how hard are 
the head impacts experienced in the Oklahoma drill, with 0 being no contact and 6 being the hardest 
hit an athlete may receive in a game?” At each focus group meeting, printed weekly practice and 
game reports will be handed out to each participant. During the first 20 minutes, a summary 
presentation of the practice and game reports, including video examples of drills conducted in the 
prior month and the associated biomechanical data measured from the mouthpiece sensors will be 
shown to the stakeholders in the form of a PowerPoint presentation. Thirty minutes will be reserved 
for a semi-structured group interview to discuss what was seen in the video and implications of the 
data on practice structure in youth football and coaching. Trained focus group leaders will lead 

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discussion guided by a series of questions and prompts. As the season progresses, questions and 
prompts may be added to the focus group guide as new topics are introduced by participants in 
previous focus groups. League officials (n=8) will be recruited to participate in pre-season (Aug) 
and post-season (Nov) key informant interviews following the same format as the focus groups. 
Study staff will take notes and collect audio recordings of the discussions. During the last 10 
minutes of each focus group meeting and key informant interview, the stakeholders will complete 
an 8-item scale on the acceptability and feasibility of creating a safer practice structure using the 
validated Acceptability of Intervention Measure (AIM) and Feasibility of Intervention Measure 
(FIM).88 This survey will be repeated at each meeting to determine changes in perceived feasibility 
and acceptability over time.  
 
In Fall 2024, Coaches (n=24) and parents (n=30) will be invited to participate in separate, team-
specific 60-minute focus groups (six for coaches, six for parents) at pre-season and post-season 
timepoints to assess domains of the Practical Robust Implementation and Sustainability Model 
(PRISM)89 implementation framework, including organizational needs, capacity, and readiness to 
adopt the intervention program. We will augment PRISM with the Interactive Systems Framework 
(ISF)90 community factor domain to additionally understand how the community may influence 
capacity and readiness. Trained focus group leaders will lead discussion guided by a series of 
questions and prompts. Organizational leaders (n=12) will be recruited to participate in a key 
informant interview following the same format as the focus groups. Study staff will take notes and 
collect audio recordings of the discussions. The questions and prompts will remain the same across 
the two meetings to measure changes in perspectives over the course of the season; however, 
questions and prompts may be added to the second discussion as new topics are introduced by 
participants in previous focus groups/interviews. During the last 5 minutes of each focus group 
meeting and interview, the stakeholders will complete an 8-item scale on the acceptability and 
feasibility of the intervention program using the validated AIM and FIM surveys.  
 
Identifying Adaptations. We will convene our community stakeholder team (n=12) to participate 
in monthly meetings (January – March 2025) to review intervention outcomes and assess program 
fit and necessary adaptations to address organizational capacity and readiness to adopt the 
intervention program. Guided by the Intervention Mapping process, the intervention program will 
be refined accordingly, while maintaining essential elements of the intervention program. The 
stakeholder team consists of youth and high school football coaches, league and school 
administrators, parents, an athletic trainer, and a director of player development for a local 
university. We have successful relationships with and support from our community stakeholder 
team. During the development phase, we had >90% engagement attendance in meetings; 75% of 
the original stakeholder team has remained engaged through the evaluation phase of our pilot 
testing. We will add additional stakeholders from the Charlotte metropolitan region to strengthen 
the diversity and expertise within our team. A written summary will be provided after each meeting 
documenting discussion and progress.   
 
Within the focus groups and league official interviews, stakeholders will be aware of other 
stakeholders included in group discussions; however, their identity within the youth football league 
will remain anonymous. Participants will be informed before the focus group and interviews if the 
session will be audio or video recorded as well as what will be done with the recordings. Audio or 
video recordings will only be used for data analysis. Because of the nature of focus groups, 
confidentiality cannot be guaranteed; however, the research team will provide procedures to 
maintain confidentiality and will inform participants not to repeat what is said in the focus groups.   
 
Stakeholder Engagement: 

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Stakeholders will be identified (n=12) and gathered for a presentation of the research findings and 
round table discussion of needs, concerns, and implications of research findings using a community 
engaged approach. Possible local stakeholders (n=8) include league officials, coaches, athletes, and 
parents, representing different levels of interest and influence. To increase generalizability, four 
stakeholders external to the local football league will be identified, including two high school 
football coaches and two Forsyth County school administrators. Stakeholder involvement will be 
voluntary and informed consent will be provided prior to the stakeholder discussions. Stakeholders 
will be aware of other stakeholders included in group discussions; however, their identity within 
the youth football league will remain anonymous.  
 
Together with the stakeholders, Dr. Urban will conduct monthly stakeholder meetings to develop 
an intervention focused on reducing head impact exposure in practice. During the first meeting, 
stakeholders will be gathered for a presentation of research findings, including identified high-risk 
activities and skills and results from focus groups, interviews, and surveys, and discussion of needs, 
concerns, and implications of the research using a community-engaged approach. We will conduct 
Intervention Mapping through three monthly stakeholder meetings to define, develop, refine, and 
select a strategy to test for reducing head impact exposure in practices.91 This will include 
specifying an action-oriented objective and clearly defining which determinants and level(s) of the 
social-ecological model will be targeted. Together, we will brainstorm possible methods to achieve 
the defined objectives. The research team will evaluate the level of evidence to support the proposed 
methods and work with the stakeholders group to translate proposed methods into strategies. 
Strategies will be developed and compiled to address the identified level(s) of the social ecological 
model and program objectives. The strategy selected for pilot testing will be determined by the 
potential to reduce head impact exposure in practices, alignment with needs of the community, 
feasibility, acceptability, availability of resources (i.e., coaching staff, tackling dummies), and 
amount of evidence to support the strategy. Acceptability will be a priority when selecting the 
strategy as guided by Conceptual Model of Implementation Research, which will be used to 
develop the implementation plan.92 Once the strategy has been selected, we will work with 
stakeholders to operationalize the approach into discrete components with a clear plan of action 
and programmatic materials. The safety of the participants will be the utmost priority in the 
development and testing of the intervention.  
 
We will work with the stakeholders to develop an implementation plan. The implementation plan 
will define characteristics of the intervention, timeline and degrees of involvement, resources and 
training materials, and a specific action plan. The Conceptual Model of Implementation Research 
will guide selection of the strategy/practice structure and development of the implementation 
plan.92 In this model, effective implementation is a function of the organization’s readiness for 
change; resources available for implementation (i.e., training and technical support); support from 
the organization’s leadership; presence of a champion; extent to which the practice structure fits 
the needs of those affected and involved in youth football practices; and extent to which 
stakeholders perceive the practice structure reflects their values. We will continually solicit input 
and feedback from stakeholders on the objectives, guidelines, resources, and evaluation criteria for 
the practice structure and strategies for effective implementation. Essential elements of 
implementation will be defined93 (e.g., minutes per practice spent on specified activities, number 
of practices per week the coach followed the practice structure).  
 
An additional 10 adult stakeholders in the youth football community will be engaged via interviews 
to provide feedback on the intervention program for future program development.  
 
 

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Intervention:  
Before the fall football season (June-July), we will recruit coaches and athletes 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. Coaches of the teams enrolled in the intervention will be trained according to guidelines 
established in the intervention development by a trained football advisor (e.g., a former college 
football player), who will be a resource throughout the season. During the season (Aug-Nov), 
trained research staff will attend all practices and games to collect biomechanical data and video 
during each session. Implementation process (i.e., feasibility and potential utility of the 
implementation strategy) will be monitored. Stakeholders will be gathered intermittently (at most 
monthly) to provide feedback on feasibility and acceptability of the intervention, including 
suggestions to improve uptake of the practice structure, if needed, and to identify implementation 
process strengths. 
 
Fifteen athletes recruited from each intervention team will be assigned an instrumented mouthpiece. 
All data will be screened to remove impacts that did not occur from a head impact. Video will be 
reviewed to characterize on-field activity and paired with the head impact sensor data and to 
determine the extent to which the intervention was implemented. Coaches will complete the 8-item 
scale assessing the acceptability and feasibility of creating a safer practice structure using the AIM 
and FIM (Appendix 2) at the start and end of the season.88 Stakeholders will complete the surveys 
at each monthly stakeholder meeting. 
 
Intervention Summary: 
The intervention will seek to reduce head impacts in youth football by (1) improving the knowledge 
and skills of youth football coaches in effective practice planning and use of safe practice drills and 
(2) changing attitudes and beliefs towards contact in practice. The activities of the intervention are 
aligned with constructs of Social Cognitive Theory94 and Diffusion of Innovation95 and are as 
follows:  
1. A pre-season educational clinic will be provided to youth football coaches. The 
educational clinic will include a panel discussion of high school football coaches 
around the topic of practice planning, presentations from medical and research 
professionals on head impact biomechanics and related sports medicine topics (e.g., 
concussion signs and symptoms, cardiovascular emergencies, heat precautions), and 
demonstrations of safe practice drills.  
2.  Coaches will be asked to follow guided practice plans that follow the 
[NO_PRINTED_FORM]National Federation for High Schools (NFHS)96 for football 
practice drills with moderated time spent on live action or full contact drills. The 
guided practice plans will designate recommended blocks of time over a 1.5-hour 
practice that may be spent on the five categories of contact: Air, Bags, Control, 
Thud/Bump, and Live contact. Three practice plans will be created that designate a full 
contact practice, moderate contact practice (no drills in the Live category), and limited 
contact practice (no drills in the Live category). 
3. Coaches will be provided a reference booklet with drill explanations, guidance on 
practice planning and drill selection, and frequently asked questions. The drills for the 
reference booklet will be gathered from local high school football coaches with 
knowledge of the NCHSAA handbook and safe practices in football.  
4. The intervention coaches will be paired with high school football coach/coaching staff 
who will serve as a trained football advisor and peer mentor. The intervention coaches 
will be asked to meet with their peer mentor weekly throughout the season to provide 
guidance on practice planning throughout the season.  

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Athlete Stakeholder Groups:   
Former youth football players  currently participating at the Varsity level of high school football 
(n=6) and collegiate level (n=6) will be invited to participate in separate (one for high school, two 
for collegiate) 60-minute discussions before the intervention (July), in the middle of the 
intervention/football season (October), after the football season (January), and upon completion of 
analysis of the results (May). The purpose of the stakeholder discussions is to assess the feasibility 
and potential utility of the implementation strategy and to further supplement our understanding of 
the intervention feasibility and acceptability. The Exploration, Preparation, Implementation, and 
Sustainment (EPIS)97 conceptual model will be used to guide discussions. During the last 10 
minutes of each discussion, participants will be asked to complete modified AIM and FIM 
surveys.88 Questions 1 and 2 of the FIM surveys will be omitted for athlete stakeholders.98 These 
surveys will be repeated at each meeting to determine changes in perceived acceptability and 
feasibility over time. 
 
Neurocognitive Assessments: 
Enrolled athletes may complete a series of clinical outcome assessments pre-and post-season, 
including measures of neurocognition, postural control, and vestibular/ocular motor symptoms. 
The parent and child versions of the Behavior Rating Inventory of Executive Function (BRIEF) 
Monitoring Form99,100 and Revised Child Anxiety & Depression Scale (RCADS)101 will be collected 
at the baseline and post-study assessments to monitor behavior and mood changes. The elements 
of the clinical outcome assessments are described below:  
 
ImPACT:   
For this study, the web-based version of the ImPACT (Immediate Post-Concussion 
Assessment and Cognitive Testing) will be given to athletes after diagnosis of a 
concussion.  Administration of the test will be monitored by a member of the study staff 
member trained in the application of the ImPACT test.  The ImPACT test takes 
approximately 20 minutes to complete.   
 
NIH Toolbox:   
The NIH Toolbox is a multidimensional set of brief measures assessing cognitive, 
emotional, motor and sensory function from ages 3-85, meeting the need for a standard set 
of measures that can be used as a “common currency” across diverse study designs, 
including repeated measures designs, such as the present study.  Specifically, we will use 
the NIH Toolbox Cognition Battery which is administered on an iPAD.  The cognition 
battery consists of tests to assess Executive Function, Attention, Episodic Memory, 
Language, Processing Speed and Working Memory.  Administering this battery will yield 
summary scores (i.e., Cognitive Function Composite Score and Crystallized Cognition 
Composite Score), as well as individual measure scores.   
 
Rey Auditory Verbal Learning Test (RAVLT): 
The RAVLT assesses verbal learning ability and memory; in this study, only learning 
ability is evaluated (4 minutes).  A series of 15 words is presented to the participant 3 times 
via audio recording for standardization, and answers are recorded.   
 
Stationary Postural Control/Force Plate:  
Consistent with the methodology outlined by Campolettano et al., participants will 
complete two 30-second trials (one with eyes opened, one with eyes closed).102 Five 
measurements will be calculated at each time point (pre- and post-season): anterior-

Protocol version: 
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11 
posterior sway, medial-lateral sway, path length, maximum path velocity, and center of 
pressure area. 
 
Vestibular/Ocular Motor Screening (VOMS):  
The participant will be asked to complete a series of rapid head movements to assess five 
domains: smooth pursuit, saccades, near point convergence, vestibular ocular reflex, and 
visual motion sensitivity. Symptom provocation will be assessed by a trained member of 
the study team. Near point convergence will be averaged across three trials.  
 
Conners’ Continuous Performance Test (CPT) Third Edition (CPT-3):  
Participants will complete a 14-minute computer-based assessment that evaluates selective, 
sustained and divided attention, as well as impulsivity and vigilance. 
 
Triggers for Testing:   
Triggers refer to the standards an athletic trainer or coach will use to determine whether or not an 
impacted player should receive further testing. The triggers for testing will be the standard already 
used by the athletic trainers and will not be altered due to this study. If a concussion is suspected, 
the athletic trainers typically use the SCAT5 on-field to determine whether to remove an athlete 
from play. Following removal from play, the athletic trainers use the SCAT5 to assist with a clinical 
diagnosis of concussion which would trigger further testing. Athletic trainers and physicians will 
follow normal methods for diagnosis and treatment of a concussion and not be restricted to only 
the information found in this protocol. 
 
Post-Injury Testing:   
Post-injury testing is any testing that is administered after a player has been diagnosed by a team 
physician or athletic trainer to have a concussion. The records for Post-Injury Testing will only be 
provided and used for research analysis AFTER a concussion has been diagnosed, pending signed 
authorization by the players on the Informed Consent document. No additional or different testing 
will be done because of a player’s participation in the study. 
 
Post-injury testing will include baseline cognitive, postural control, and vestibular/ocular motor 
testing within 24-48 hours after concussion diagnosis.  
 
 
Outcome Measure(s) 
• 
Primary Outcomes:  
o Number of head impacts, impact rate 
o Mean and 95th percentile number of impacts, linear acceleration, rotational acceleration by 
session type, activity, skill and behavior 
o Pre- to Post-Season change scores for:  
 
ImPACT 
 
NIH Toolbox 
 
RAVLT 
 
Postural Control 
 
VOMS 
 
Conners’ CPT 
• 
Secondary Outcomes:  
o Implementation facilitators and barriers 
o Intervention fidelity 
o Adaptation of the intervention 
 

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12 
Analytical Plan 
Statistical analysis of biomechanical data will be based on our previous approaches.9,11,64 Head impact data 
will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and 
quantified for each session (i.e., practice or game) and practice drill category (i.e., conditioning, tackling) 
and across drill types (i.e., Oklahoma, one-on-one) in terms of mean number of impacts and impact rate 
and mean and 95th percentile head acceleration.  
 
Descriptive statistics will be computed from survey responses using SAS. Field notes and recordings from 
focus meetings will be reviewed by reading transcripts and listening to recordings to identify recurrent 
themes, issues, and concepts and a thematic framework will be created surrounding the awareness and 
receptivity of the stakeholders to create a safer practice structure.103 Data will be indexed, charted, and 
mapped using a schematic diagram to guide interpretation of the results. Survey questions and responses 
will be grouped according to the thematic framework. Perceived feasibility (FIM), acceptability (AIM), and 
stakeholder survey constructs measured at the initial meeting (Aug) will be compared to the final meeting 
(Nov).  
 
We will use established qualitative methods104,105 to analyze field notes and recordings from stakeholder 
meetings to iteratively assess the nature of the evidence-based strategies, strengths, and weaknesses, while 
addressing the availability, acceptability, affordability, and potential barriers with each possible evidence-
based strategy. Field notes and recordings from stakeholder meetings will be reviewed by reading 
transcripts and listening to recordings to identify recurrent themes, issues, and concepts for the creation of 
a thematic framework.103 Attitudes, practices, barriers, needs, and concerns will be categorized. Common 
themes will be grouped with the aforementioned categories or new categories will be created as themes 
emerge. Survey responses, transcriptions, and recordings will be indexed and charted based on the 
classifications identified in the thematic framework. These data will finally be mapped and interpreted to 
establish associations, explanations, and strategies that target the individual-, interpersonal-, and 
community-levels influencing behaviors affecting head impact exposure. These data will ultimately inform 
the development of the practice structure, implementation plan, and evaluation framework. 
 
On-field head impact data for each athlete will be quantified for each practice or game by number of 
impacts, impact rate, mean, median, and 95th percentile of head acceleration, and location of impact. Impact 
rates and percentiles (i.e., 50th, 95th) computed from the distribution of accelerations will be compared 
between unexposed (year 2, published iTAKL and BRP study data61,106–108) and exposed seasons of data 
collection. Mixed-effects models (in SAS) will be used to assess differences in head impact exposure in 
practices and games before (year 2, published iTAKL and BRP study data61,106–108) and after the 
intervention, adjusting for confounding factors, including team. We will examine the consistency of 
intervention effects on exposure outcomes between teams and among players over time, with the goal of 
learning how to refine and tailor the intervention to increase adherence and potential effectiveness. Because 
this is a pilot study, we will lack sufficient power to fully test the effectiveness of the intervention; however, 
we will gather essential information for a future R01-supported randomized control trial.  
 
All clinical assessment scores will be compared to same age peers at testing time (via published normative 
values) to control for developmental changes that may occur during the study period. Scores will be 
normalized (i.e. z-scores) to facilitate comparisons among cognitive tests. Kinematic metrics (i.e., total 
impacts, 95th percentile accelerations and rotational velocity, RWE) will be time-varying covariates in 
generalized linear and mixed effects models. The modeling framework, with its random effects structure, 
will allow for assessment of clinical outcome differences pre- to post-season over time between the 
intervention athletes and controls. We will also describe whether associations may vary according to 
athletes’ characteristics.  
 

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13 
Descriptive data and inferential statistics related to implementation facilitators and barriers (i.e., feasibility, 
acceptability), fidelity (i.e., extent to which the intervention was implemented as prescribed), and adaptation 
(i.e., changes) of the intervention will be analyzed. These data will be abstracted from standardized forms 
collected during on-field observations, video-analysis of practices and games, and brief surveys and field 
notes from stakeholder feedback meetings.103 Common themes will be grouped, and qualitative data 
indexed and charted. These data will be analyzed to assess the degree to which the practice structure was 
effective at reducing head impact exposure, was adopted by the youth football coaches, and to identify the 
key components of the strategy that may be implemented and sustained over time.  
 
Human Subjects Protection 
 
Subject Recruitment Methods 
Dr. Urban will work with the league executive board to arrange meetings for coaches, parents, and players 
to describe the study and provide opportunities to answer questions. She and study personnel will also 
attend pre-season conditioning sessions to meet with parents, coaches, and athletes not present at the 
meetings. Those not present at the meetings or pre-season conditioning sessions will be sought out 
individually by phone for their interest in participating in the study. All interested athletes on these teams 
will be allowed to participate; of those enrolled, 15 children on each team will be randomly selected for 
instrumentation with head impact sensors using a random numbers table. Coaches and parents of the 
participating teams will be recruited to participate in separate focus groups and league officials will be 
prospectively recruited to participate in key informant interviews. A new set of football coaches and teams 
will be prospectively recruited and enrolled in the intervention portion of this study using similar 
recruitment strategies as the controls. Informed consent will be obtained from adults (coaches, parents, and 
league officials) and parents/legal guardians of all youth athletes and participating athletes will sign consent 
and assent forms.  
 
To maintain a robust cohort of subjects, we will enroll all interested subjects from each team for possible 
participation in the study and randomly choose 15 per team for study at the start of the season. Participation 
will be monitored weekly; if an athlete has attended 50% or less of the practices or games within a 3 weeks, 
a new subject who enrolled prior to the start of the season will be randomly chosen for biomechanical data 
collection and given a sensor. We anticipate a possible attrition rate of 15% based on experience from our 
existing R01s. To ensure that sufficient participants are included, we will work closely with the local youth 
football league to identify and engage additional teams, if needed. 
 
To reward all subjects for attending appointments to complete baseline, post-injury, and post-season 
evaluation procedures during the contact sport seasons, a gift card will be awarded, at all appointments, for 
the subject’s additional travel and time to attend the procedures. See the table below for gift card 
compensation amounts. 
 
 
 
 
 
 
 
 
Neurocognitive 
Testing 
Dental Impressions + 
Head/Face 
Measurements 
Neurocognitive 
Testing, 
Dental 
Impressions, 
+ 
Head/Face 
Measurements 

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14 
Pre-season/baseline 
$20 
$20 
$40 
Post-injury 
$20 
N/A 
 
Post-season 
$40 
N/A 
 
 
 
 
To reward all stakeholders for attending all meetings, focus groups or key informant interviews, a gift card 
will be awarded, at all appointments, for the additional travel and time to attend the meetings.  See the table 
below for gift card compensation amounts. To encourage participation, participants enrolled in the focus 
groups and key informant interviews will be entered into a raffle for four Wake Forest Football Tickets.  
All focus group and key informant interview participants enrolled in the study at the time of the raffle will 
be eligible to win. Winner will be selected using a random numbers table.  
 
 
Focus Groups 
Key Informant 
Interviews 
Stakeholder 
Meetings 
Athlete Stakeholder 
Meetings 
Compensation for 
each meeting  
$20 
$20 
$20 
$20 
Number of meetings 
4 
2 
18 
4 
Total compensation* 
$80 
$40 
$360 
$80 
 
 
 
*if all meetings are attended 
 
The gift card will be given to the subject at the time of the meeting. A record confirming receipt by the 
subjects of the gift card will be kept.    
 
Informed Consent 
 
Signed informed consent will be obtained from each subject.  Dr. Urban and trained study personnel will 
work with the league executive board to arrange meetings for coaches, parents, and players to describe the 
study and provide opportunities to answer questions. She and trained study personnel will also attend pre-
season conditioning sessions to meet with parents, coaches, and athletes not present at the meetings. Those 
not present at the meetings or pre-season conditioning sessions will be sought out individually by phone 
for their interest in participating in the study. 
 
Informed consent will be obtained from each subject by the members of the study staff that are not directly 
affiliated with the prospective football programs or athletic departments. The informed consent form will 
be presented in individual meetings to each prospective participant in detail. Players, parents, and coaches 
will be encouraged to ask questions and will be given the opportunity to have all questions answered. The 
prospective participants will be told their participation is completely voluntary and they will not be 
pressured into participation. During the consent process, the study staff will work to minimize the 
possibility of coercion or undue influence. It is estimated that the individual consent process will take 
approximately 15 minutes per participant. The prospective participants will be spoken to in a one-on-one 
manner in a conversation that will take place in private, away from the rest of the team to avoid the potential 
for peer pressure. 
 

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15 
An anonymous survey will be distributed to parents, coaches and league officials. A cover letter will be 
included stating that completion of the survey indicates consent to participate. The identity of those who 
have completed the survey will not be known to the research team.   
 
Lastly, stakeholder involvement will be voluntary and informed consent will be provided prior to the 
stakeholder discussions. Stakeholders will be aware of other stakeholders included in group discussions as 
discussions will be conducted face to face; however, their identity within the youth football league will 
remain anonymous.  
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study outcomes, 
minimizing to the fullest extent possible the collection of any information that could directly identify 
subjects, and maintaining all study information in a secure manner.  To help ensure subject privacy and 
confidentiality, only a unique study identifier will appear on the data collection form.  Any collected 
patient identifying information corresponding to the unique study identifier will be maintained on a 
linkage file, store separately from the data.  The linkage file will be kept secure, with access limited to 
designated study personnel.  Following data collection subject identifying information will be 
destroyed, consistent with data validation and study design, producing an anonymous analytical data 
set.  Video and biomechanics data will be stored for six years, or five years after the completion of the 
study, whichever is longer. Data access will be limited to study staff.  Data and records will be kept 
locked and secured, with any computer data password protected.  No reference to any individual 
participant will appear in reports, presentations, or publications that may arise from the study. 
 
Prevent Biometrics creates one of the mouthguards used in this study. Some information is required to 
create an account to use Prevent, such as your name, email address, password, date of birth, gender, 
height, weight, and in some cases your mobile telephone number. We may also choose to provide other 
types of information, such as a profile photo, biography, country information, and community 
username. Athlete’s name and email address will not be provided to Prevent Biometrics. We will use 
anonymous study identifiers and our generic study email to protect participant confidentiality with the 
Prevent Biometrics system. The Prevent Privacy Policy is provided in the appendix.  
 
 
FITBIR 
 
Data from the study may be submitted to the Federal Interagency Traumatic Brain Injury (FITBIR) 
informatics system.  FITBIR is a computer system run by the National Institutes of Health that allows 
researchers studying traumatic brain injury to collect and share information with each other.  
 
During and after the study, the researchers will send information to FITBIR.  However, before they 
send it to FITBIR, they will remove information such as name, date of birth, and city of birth, and 
replace that information with a code number.  FITBIR will not be able to contact participants 
 
Data and Safety Monitoring 
Dr. Urban and mentor, Dr. Kristie Foley, will be responsible for the overall monitoring of the data and 
safety of study participants. Data analysis will be overseen and completed by Dr. Urban under the 
guidance of Dr. Foley and co-mentors. Only members of the research team overseen by Dr. Urban will 
receive the acceleration data from the mouthpieces and be required to interpret the data. Team medical 
personnel and coaches will not review or monitor head impact data. Dr. Urban will pilot test the 
intervention developed in this study and complete data analysis under the supervision of Dr. Foley. 
 

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16 
The Wake Forest School of Medicine Institutional Data Safety and Monitoring Board (I-DSMB) will 
provide independent oversight of methodology and conduct, biostatistics, and ethics of this study. The 
I-DSMB provides oversight for Wake Forest Baptist Health investigator-initiated, locally conducted 
clinical trials receiving NIH support.  Members of the Wake Forest School of Medicine I-DSMB have 
expertise in clinical trial methodology and conduct, biostatistics, ethics, and clinical research.  The I-
DSMB will monitor participant safety, evaluate the progress of the study, review procedures for 
maintaining the confidentiality of data, and the quality of data collection, management, and analyses.  
The I-DSMB will have access to all study data, documents and progress information, and will be 
notified of all changes that are made to the protocol.   
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes 
will be promptly reported by the principal investigator or designated member of the research team to 
the IRB and sponsor or appropriate government agency if appropriate. 
 
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Appendix 
1. Research Timeline 
2. Stakeholder Surveys 
 
 
 
 
 

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Appendix 1. Timeline 
 

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Appendix 2. Stakeholder Surveys 
 
Youth Football Stakeholder Survey  
 
We would like to invite you to take part in a research project. The purpose of this research is to 
understand the knowledge and perspectives related to concussions and hits to the head in youth football.  
This survey will take about 10 minutes to complete.  Your part in this study is anonymous.  This means 
that no one will know if you took part in this study and no one, including the researcher, will know what 
your answers are.  Any reports or publications based on this research will only use group data and will not 
identify you or any individual as being part of this study.  If you have any questions, please contact Dr. 
Jillian Urban (jurban@wakehealth.edu, 336-716-0947).  Completion of this survey indicates that you 
consent to participate.  
 
Football and Sport History (4-13 questions) 
 
Are you a parent, coach or league official? Parent; Coach; League Official [check boxes] 
 
[If Coach] 
What level of play do you currently coach? (select all that apply)  
Tine Mite     Mighty Mite     10U     Jr Pee Wee     12U     Pee Wee     13U     Jr Midget     14U     High 
School     Collegiate     Semi-Professional    Professional    Other      
 
Do your children/child participate in football?  
Yes    No      
 
 
[If yes] 
What level of play do your children/child play? (select all that apply)  
Tine Mite     Mighty Mite     10U     Jr Pee Wee     12U     Pee Wee     13U     Jr Midget     14U     High 
School     Collegiate     Semi-Professional    Professional     Other     Not Sure 
 
[If yes] 
Do your children/child participate in the Piedmont Youth Football and Cheer League (PYFCL)? Yes    
No     Not Sure 
 
[If yes] 
What position(s) do your child/children participate in? (select all that apply) 
Center     Offensive guard     Offensive tackle    Quarterback     Running back     Wide receiver     
Tight end     Defensive tackle     Defensive end     Middle linebacker     Outside linebacker    Defensive 
back    Special teams     Other:_____ 
 
[If yes] 
Has your child ever been diagnosed with a concussion? 
Yes    No     Not Sure 
 
[If yes] 
Has your child ever been diagnosed with a concussion while participating in football activities? 
Yes    No     Not Sure 
 
Have you ever played tackle football?  
Yes    No      
 

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[If yes] 
What levels of play have you participated in? (select all that apply)  
Youth     High School     Collegiate     Semi-Professional    Professional    Other      
 
[If yes] 
What age did you start playing football?  
<5 years old     5-10 years old     11-13 years old    14-18 years old    >18 years old 
 
[If yes] 
Have you ever been diagnosed with a concussion?  
Yes    No    Not Sure 
 
[Yes] 
Do you feel you have any lasting effects from your concussion(s)?  
Yes     No    Not sure 
 
Knowledge and Beliefs (10 questions) 
 
Directions: These statements about concussions may or may not be true. Please rate how strongly 
you agree with each statement. 
 
People who have had a concussion are more likely to have another concussion. 
Strongly Disagree, Disagree, Somewhat Disagree, Neither Agree nor Disagree, Somewhat 
Agree, Agree, Strongly Agree 
 
A concussion cannot cause brain damage unless the person has been knocked out. 
Strongly Disagree, Disagree, Somewhat Disagree, Neither Agree nor Disagree, Somewhat 
Agree, Agree, Strongly Agree 
 
A concussion can only occur if there is a direct hit to the head. 
Strongly Disagree, Disagree, Somewhat Disagree, Neither Agree nor Disagree, Somewhat 
Agree, Agree, Strongly Agree 
 
Hits to the head that do not result in concussion may affect brain health after one season. 
Strongly Disagree, Disagree, Somewhat Disagree, Neither Agree nor Disagree, Somewhat 
Agree, Agree, Strongly Agree 
 
Hits to the head that do not result in concussion may affect brain health later in life.  
Strongly Disagree, Disagree, Somewhat Disagree, Neither Agree nor Disagree, Somewhat 
Agree, Agree, Strongly Agree 
 
Do you feel that efforts should be taken to reduce concussions in football?  
Definitely yes     Probably yes     Not sure     Probably not     Definitely not 
 
Do you feel that hits to the head that do not result in concussion should be avoided in football?  
Definitely yes     Probably yes     Not sure     Probably not     Definitely not 
 
Do you think there should be limits on the amount of contact allowed in football practices?  
Definitely yes     Probably yes     Not sure     Probably not     Definitely not 

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Do you think there should be limits on tackling drills allowed in football practices?  
Definitely yes     Probably yes     Not sure     Probably not     Definitely not 
 
In your opinion, what is the greatest opportunity to reduce hits to the head in youth football?  
a) Limitations on contact in practice 
b) Limitations on drills allowed in practice 
c) Workshops for athletes to teach proper technique 
d) Workshops for coaches to learn safe practices in sport 
e) Rule changes in games 
f) Safer helmets/equipment 
g) Reducing equipment worn by athletes (e.g., removing helmet during practice) 
h) Changing the culture around hits in football (e.g., discouraging celebration of big 
hits) 
i) No improvements are needed 
j) Other, specify: 
 
Which of the following will be the easiest to put in place?  
a) Limitations on contact in practice 
b) Limitations on drills allowed in practice 
c) Workshops for athletes to teach proper technique 
d) Workshops for coaches to learn safe practices in sport 
e) Rule changes in games 
f) Safer helmets/equipment 
g) Reducing equipment worn by athletes (e.g., removing helmet during practice) 
h) Changing the culture around hits in football (e.g., discouraging celebration of big 
hits) 
i) No improvements are needed 
j) Other, specify: 
 
Perceived Susceptibility (5 questions) 
 
Do you think children have more hits to the head while playing football compared to other contact sports 
(e.g., lacrosse, soccer)? 
Much more     Slightly more     About the same     Slightly less     Much less 
 
Do you think children have more hits to the head while playing football compared to non-contact sports 
(e.g., swimming, tennis)? 
Much more     Slightly more     About the same     Slightly less    Much less 
 
What position do you think has the greatest number of hits to the head in football?  
Center     Offensive guard     Offensive tackle    Quarterback     Running back     Wide receiver     Tight 
end     Defensive tackle     Defensive end     Middle linebacker     Outside linebacker    Defensive back    
Special teams      Other      Equal risk across positions 
 
What position do you think receives the hardest hits to the head in football?  
Center     Offensive guard     Offensive tackle    Quarterback     Running back     Wide receiver     Tight 
end     Defensive tackle     Defensive end     Middle linebacker     Outside linebacker    Defensive back    
Special teams      Other      Equal risk across positions 
 

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Do you think children playing football make contact with their helmet (i.e., receive hits to the head) more 
often during games compared to practices?  
Much more     Slightly more     About the same     Slightly less    Much less 
 
 
Perceived Severity (5 questions) 
 
How serious do you think it is for… 
your child/children to have a concussion in football?  
Not serious at all    Somewhat serious     Serious     Very serious    Extremely serious 
 
your child/children to receive a hard hit to the head in football practices?  
Not serious at all    Somewhat serious     Serious     Very serious    Extremely serious 
 
your child/children receive a hard hit to the head in football games?  
Not serious at all    Somewhat serious     Serious     Very serious    Extremely serious 
 
How many hits to the head (making contact with his/her helmet) during a single practice or game would 
cause you concern?  
Less than 5 impacts    6-15     16-25     26-50    Greater than 50 head impacts    I am not concerned about 
the number of head impacts    Unknown 
 
If your child/children had a concussion in football, would you be concerned about any of the following 
outcomes:  
Missing one or more practice 
 
 
 
Yes  
No 
Missing one or more games. 
 
 
 
Yes 
No 
Missing one or more days of school. 
 
 
Yes 
No 
Decreased performance at school. 
 
 
Yes 
No 
Decreased performance in football. 
 
 
Yes 
No 
Persistent symptoms following concussion. 
 
Yes 
No 
Increased risk of second concussion.  
 
 
Yes 
No 
Short-term (i.e., single season) effects on brain health. 
Yes 
No 
Long-term (i.e., later in life) effects on brain health. 
Yes 
No 
Other: _____________ 
 
 
Perceived Needs/Barriers (6-8 questions) 
 
Having a competitive team is more important than reducing hits to the head in football practices.  
Strongly Disagree     Disagree    Neither Agree nor Disagree   Agree     Strongly Agree. 
 
Football teams need to reduce hits to the head in practices.  
Strongly Disagree     Disagree    Neither Agree nor Disagree   Agree     Strongly Agree. 
 
It will be costly to reduce hits to the head in football practices. 
Strongly Disagree     Disagree    Neither Agree nor Disagree   Agree     Strongly Agree. 
 
Reducing hits to the head in football practices will help teams win games. 
Strongly Disagree     Disagree    Neither Agree nor Disagree   Agree     Strongly Agree. 
 
Coaches will be willing to change their practice structure to reduce hits to the head.  

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Strongly Disagree     Disagree    Neither Agree nor Disagree   Agree     Strongly Agree. 
 
League officials will be willing to put policies into place to reduce hits to the head. 
Strongly Disagree     Disagree    Neither Agree nor Disagree   Agree     Strongly Agree. 
 
Please provide any additional comment on needs within the football community to create safer practices. 
 
Please provide any additional comment on barriers within the football community to creating safer 
practices. 
 
Self-Efficacy (3 questions) 
 
My youth football league will be able to reduce hits to the head in practices. 
Strongly Disagree     Disagree    Neither Agree nor Disagree   Agree     Strongly Agree. 
 
My youth football league is willing to commit to reducing hits to the head in practices.  
Strongly Disagree     Disagree    Neither Agree nor Disagree   Agree     Strongly Agree. 
 
My youth football league has the ability to maintain efforts to reduce hits to the head in practices. 
Strongly Disagree     Disagree    Neither Agree nor Disagree   Agree     Strongly Agree. 
 
__________________________________________________________________________________ 
  
Demographic (4 questions) 
What is your age? 
Under 18     18-24     25-34     35-44     45-54     55-64     65-74     75-84     85 or older 
 
What is your gender?  
Male     Female    Prefer not to answer 
 
How would you best describe yourself?  
American Indian/Alaska Native     Asian     Black or African American     Native Hawaiian or Other 
Pacific Islander     White    Other    Prefer not to answer     
 
Are you of Hispanic/Latino/Spanish origin? 
Yes     No    Prefer not to answer  
 

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Practice Survey for Coaches 
 
The purpose of this survey is to understand how often specific drills are included in your practices and the 
perceived frequency and magnitude of hits experienced in five common youth football drills.  This survey 
will take about 8 minutes to complete.  If you have any questions, please contact Dr. Jillian Urban 
(jurban@wakehealth.edu, 336-716-0947).   
 
1. What is your age? 
Under 18     18-24     25-34     35-44     45-54     55-64     65-74     75-84     85 or older 
 
2. Do you have a child/children who currently participates in youth football?  
Yes    No      
 
 
3a. [If yes] Do you have a child/children who currently participates in the Piedmont Youth Football 
and Cheer League (PYFCL)? Yes    No     Not Sure 
 
3. What level of play do you currently coach? (select all that apply)  
Tiny Mite     Mighty Mite     10U     Jr Pee Wee     12U     Pee Wee     13U     Jr Midget     14U     Other, 
Specify:      
 
4. What other levels of play have you previously coached? (select all that apply)  
Tiny Mite     Mighty Mite     10U     Jr Pee Wee     12U     Pee Wee     13U     Jr Midget     14U      
High School 
Collegiate 
Professional  
Other     Not Sure  
None 
 
5. How many years have you coached football (any level)?  
 
 
0-first year coaching 
1-2 
3-5 
6-10 
11-20 More than 20 years 
 
6. How many years have you coached youth football?  
 
 
0-first year coaching 
1-2 
3-5 
6-10 
11-20 More than 20 years 
 
7. How many years have you personally played football (any level)?  
 
 
0 
1-2 
3-5 
6-10 
11-20 More than 20 years 
 
8. What levels of football have you personally played? 
Youth High School 
Collegiate 
Semi-Professional 
Professional 
 
PRACTICES 
 
9. How many days/week does your team have full contact (i.e., full-speed drills, tackling to the 
ground) practice? 
0 
1 
2 
3 
4 
5 
6 
7 
 
 
10. Do wins/losses affect your practice structure (i.e., what drills are conducted and when) the 
following week? 
a) Always      
b) Most of the time      
c) About half of the time      
d) Sometimes    
e) Never 
 
 

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32 
11. How often do you include the following drills in your practice structure?  
 
Install: Intra-team scrimmage of offense & defense game strategies in a game-like situation  
Every practice  
Most practices  
Some practices  
A few practices  
 
I never do this drill 
 
Oklahoma: 2 vs 2 or 3 vs 3 tackling drill with tackler, blockers, & ball carrier; Simulate game speed 
while working to improve blocking, running, & tackling technique in a confined space 
Every practice  
Most practices  
Some practices   
A few practices   
 
I never do this drill 
 
One-on-one: 1 vs 1 tackling drill with the 2 athletes starting less than 3 yards apart; Improve one-on-one 
tackling form & technique 
Every practice  
Most practices  
Some practices   
A few practices   
 
I never do this drill 
 
Open-field tackling: 1 vs 1 tackling drill with the 2 athletes starting more than 3 yards apart; Improve 
form & technique in full-speed game-like situations 
Every practice  
Most practices  
Some practices   
A few practices   
 
I never do this drill 
 
Position skill work: Athletes separate into offense & defense groups; practice offensive- or defensive-
specific skills & game strategy 
Every practice  
Most practices  
Some practices   
A few practices   
 
I never do this drill 
 
Conditioning: Running, legwork, push-ups, etc 
Every practice  
Most practices  
Some practices   
A few practices   
 
I never do this drill 
 
12. On average, how many times do you think a player makes contact with their helmet (i.e., receives 
a hit to the head) during a full contact practice? 
a) <5 times per practice 
 
b) 6-10 times per practice 
 
c) 11-20 times per practice  
d) More than 20 times per practice 
 
13. On average, how many times do you think a player makes contact with their helmet (i.e., receives 
a hit to the head) during a thud (i.e., low or half-speed drills, no tackling to the ground) practice? 
a) <5 times per practice 
b) 6-10 times per practice 
c) 11-20 times per practice 
d) More than 20 times per practice 
 
14. On a scale of 0 to 6, with 0 being no contact and 6 being the hardest hit an athlete may receive in 
a game, how hard are the head impacts experienced in each drill? 
Install:  
0 
1 
2 
3 
4 
5 
6 
 
 
Oklahoma:  
0 
1 
2 
3 
4 
5 
6 
 

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33 
 
One-on-one:  
0 
1 
2 
3 
4 
5 
6 
 
 
Open-field tackling:  
0 
1 
2 
3 
4 
5 
6 
 
 
Position skill work:  
0 
1 
2 
3 
4 
5 
6 
 
 
15. What do you think contributes most to how often a player makes contact with their helmet (i.e., 
receives a hit to the head) in practice? 
a) Tackling technique 
b) Practice drills/structure of practice 
c) Player position 
d) Peer and/or coach pressure 
e) Aggressive behavior/wanting to engage in contact 
f) Other, specify: 
 
16. Would you be interested in knowing how hard your athletes make contact with their helmet (i.e., 
receive hits to the head) in practice? 
a) Very interested 
b) Interested 
c) Slightly interested 
d) Not interested at all 
 
17. Would you be interested in knowing how often your athletes make contact with their helmet (i.e., 
receive hits to the head) in practice? 
a) Very interested 
b) Interested 
c) Slightly interested 
d) Not interested at all 
 
18. What do you think is the greatest opportunity for improving head impact safety in youth football? 
k) Limitations on contact in practice 
l) Limitations on drills allowed in practice 
m) Workshops for athletes to teach proper technique 
n) Workshops for coaches to learn safe practices in sport 
o) Rule changes in games 
p) No improvements are needed 
q) Other, specify: 
 
19. Head impact sensors measure how hard and how often athletes hit their head in sports.  Would 
you be interested in designing a practice plan informed by head impact sensor data? 
a) Very interested 
b) Interested 
c) Slightly interested 
d) Not interested at all 
 
 
 

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34 
Organizational Readiness for Implementing Change (ORIC) – youth football  
 
[League officials or Coaches] are committed to making football practices safe. 
[League officials or Coaches] are determined to make football practices safe. 
[League officials or Coaches] are motivated to make football practices safe. 
[League officials or Coaches] want to make football practices safe. 
[League officials or Coaches] feel confident that they can keep the momentum going in making 
football practices safe. 
[League officials or Coaches] feel confident that they can manage the politics of making football 
practices safe. 
[League officials or Coaches] feel confident that the youth football organization can get people 
invested in making football practices safe. 
[League officials or Coaches] feel confident that they can coordinate tasks so that efforts to make 
football practices safe goes smoothly. 
[League officials or Coaches] feel confident that they can keep track of progress in efforts to 
make football practices safe. 
[League officials or Coaches] feel confident that they can handle the challenges that might arise 
in making football practices safe. 
 
 
Adult participants will complete an 8-item scale on the acceptability and feasibility of creating a safer 
practice structure using the validated Acceptability of Intervention Measure (AIM) and Feasibility of 
Intervention Measure (FIM).88 

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35 
Football Tackle Technique Survey 
 
We would like to invite you to take part in a research project. The purpose of this research is to 
understand the knowledge and perspectives related to tackling techniques and hits to the head in 
football. This survey will take between 5 to 10 minutes to complete.  Your part in this study is 
anonymous.  This means that no one will know if you took part in this study and no one, including the 
researcher, will know what your answers are.  Any reports or publications based on this research will only 
use group data and will not identify you or any individual as being part of this study.  If you have any 
questions, please contact Dr. Jillian Urban (jurban@wakehealth.edu, 336-716-0947).  Completion of this 
survey indicates that you consent to participate. 
Survey Questions 
 
1. What level of play do you currently coach? (select all that apply)  
a) Youth Tackle 
b) Youth Flag 
c) High School 
d) Collegiate 
e) Semi-Professional 
f) Professional 
g) None 
h) Other 
 
2. What other levels of play have you previously coached? (select all that apply)  
a) Youth Tackle 
b) Youth Flag 
c) High School 
d) Collegiate 
e) Semi-Professional 
f) Professional 
g) None 
h) Other 
 
3. How many years have you coached football (any level)?  
a) 0 
b) 1-2 
c) 3-5 
d) 6-10 
e) 11-20 
f) More than 20 years 
 
4. What levels of football have you personally played? 
a) Youth Tackle 
b) Youth Flag 
c) High School 
d) Collegiate 
e) Semi-Professional 
f) Professional 
g) None 
h) Other 
 
5. How many years have you personally played football (any level)?  

Protocol version: 
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36 
a) 0 
b) 1-2 
c) 3-5 
d) 6-10 
e) 11-20 
f) More than 20 years 
 
6. During your football career, what method of teaching tackling technique were you taught as a 
player?  Please describe the method in the free text box below. 
a) Free text box 
 
7. What method of teaching tackling technique is currently used by your coaches to teach proper 
tackling technique?  Please select all that apply. 
a. Heads-Up Football/CoachUp 
b. Rugby-Style Tackling/Hawk Tackling 
c. Shoulder Tackling System 
d. Other – free text box 
e. Unknown 
f. None 
 
8. Have you completed any formal training (eg. Webinar, in-person training, etc.) in the methods of 
tackling technique that you currently use? 
a) Yes 
b) No 
c) Unsure 
 
9. How many years have you and your coaches used this method of teaching tackling technique? 
a) Less than 1 year 
b) Between 1 and 2 years 
c) Between 3 and 4 years 
d) More than 4 years 
 
10. Which phrases do your coaches use to teach tackling techniques in games and practices? Please 
select up to five phrases used by your staff most often. 
a) Eyes on the Hip 
b) Break Down 
c) Chop Your Feet 
d) Shimmy 
e) Plant Your Foot 
f) Head Up 
g) Eyes Up 
h) Shoulder Across 
i) Shoulder on the Hip 
j) Wrap Up 
k) Facemask on Shoulder 
l) Hit, Wrap, Drive 
m) Get Low 
n) Tackle through the Numbers 
o) See What You Hit 
p) Other – free text box 
 

Protocol version: 
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37 
11. Which practice drills do your coaches use to teach and reinforce proper tackling technique in 
athletes?  Please select up to five drills used in your practices most often. 
a) Open Field Tackling – 1 on 1 tackling with greater than 3 yards at start of drill 
b) Tackle Dummy or Sled – Athlete tackles dummy or sled 
c) 1 on 1 Tackling – 1 on 1 tackling with less than 3 yards at start of drill 
d) Angle Tackle/Eye Opener Tackling Drill – 1 on 1 tackling where athletes approach at an 
angle 
e) Shed the Blocker Tackle Drill – Linebackers and Defensive Linemen shedding blocks 
f) Shuffle and Lift Drill/Explosion Lift Drill – Half speed drill where tackler practices rolling 
hips and lifting ball carrier after initial contact 
g) Wave Drill/Linebacker Hole Drill – Tackler must read the hole and tackler ball carrier 
h) 4 Point Explosion Drill – Athletes begin resting knees and explode forward to push 
opposing athlete 
i) Other – free text box 
 
12. If your coaching staff uses film review, what is the purpose of reviewing film with your team?  
Please select all that apply 
a) We do not review film  
b) Review team performance 
c) Review athlete specific performance 
d) Review game strategy 
e) Teach or reinforce technique 
f) Highlight big plays/hard hits 
g) Other – free text box 
 
13. How many hours per week does your coaching staff use film to teach and reinforce proper tackling 
technique in current athletes? 
a) We do not review film for technique  
b) < 1 hour per week 
c) 1-2 hours 
d) 2-3 hours 
e) 3-4 hours 
f) >4 hours 
 
14. In your opinion, how effective is your instruction in practice for athletes to use proper technique 
during games and scrimmages? 
a) Very effective 
b) Effective 
c) Moderately effective 
d) Slightly effective 
e) Not effective  
 
 
Demographic (4 questions) 
15. What is your age? 
Under 18     18-24     25-34     35-44     45-54     55-64     65-74     75-84     85 or older 
 
16. What is your gender?  
Male     Female    Prefer not to answer 
 
17. How would you best describe yourself?  

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38 
American Indian/Alaska Native     Asian     Black or African American     Native Hawaiian or Other Pacific 
Islander     White    Other    Prefer not to answer     
 
18. Are you of Hispanic/Latino/Spanish origin? 
Yes     No    Prefer not to answer  

Protocol version: 
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39 
Survey for Intervention Stakeholders 
 
The purpose of this survey is to understand what you think of the practice plan intervention.  This survey 
will take about 10 minutes to complete.  If you have any questions, please contact Dr. Jillian Urban 
(jurban@wakehealth.edu, 336-716-0947). 
 
Guided Practice Plan 
 
Acceptability of Intervention Measure (AIM) 
 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. The guided practice plan meets my 
approval. 
 
 
 
 
 
2. The guided practice plan is appealing to 
me. 
 
 
 
 
 
3. I like the guided practice plan. 
 
 
 
 
 
4. I welcome the guided practice plan. 
 
 
 
 
 
 
Feasibility of Intervention Measure (FIM) 
 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. The guided practice plan seems 
implementable. 
 
 
 
 
 
2. The guided practice plan drills seems 
possible. 
 
 
 
 
 
3. The guided practice plan drills seems 
doable. 
 
 
 
 
 
4. The guided practice plan seems easy to 
use. 
 
 
 
 
 
 
 
 
Use of Safe Practice Drills 
 
Acceptability of Intervention Measure (AIM) 
 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. The use of safe practice drills meets my 
approval. 
 
 
 
 
 
2. The use of safe practice drills is appealing 
to me. 
 
 
 
 
 
3. I like the use of safe practice drills. 
 
 
 
 
 
4. I welcome the use of safe practice drills. 
 
 
 
 
 
 

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40 
Feasibility of Intervention Measure (FIM) 
 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. The use of safe practice drills seems 
implementable. 
 
 
 
 
 
2. The use of safe practice drills seems 
possible. 
 
 
 
 
 
3. The use of safe practice drills seems 
doable. 
 
 
 
 
 
4. The use of safe practice drills seems easy 
to use. 
 
 
 
 
 
 
 
 
Coach Peer Mentor Program 
 
Acceptability of Intervention Measure (AIM) 
 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. The coach peer mentor program meets 
my approval. 
 
 
 
 
 
2. The coach peer mentor program is 
appealing to me. 
 
 
 
 
 
3. I like the coach peer mentor program. 
 
 
 
 
 
4. I welcome the coach peer mentor 
program. 
 
 
 
 
 
 
Feasibility of Intervention Measure (FIM) 
 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. The coach peer mentor program seems 
implementable. 
 
 
 
 
 
2. The coach peer mentor program seems 
possible. 
 
 
 
 
 
3. The coach peer mentor program seems 
doable. 
 
 
 
 
 
4. The coach peer mentor program seems 
easy to use. 
 
 
 
 
 
 
Demographic (4 questions) 
1. What is your age? 
Under 18     18-24     25-34     35-44     45-54     55-64     65-74     75-84     85 or older 
 
2. What is your gender?  
Male     Female    Prefer not to answer 

Protocol version: 
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41 
 
3. How would you best describe yourself?  
American Indian/Alaska Native     Asian     Black or African American     Native Hawaiian or Other Pacific 
Islander     White    Other    Prefer not to answer     
 
4. Are you of Hispanic/Latino/Spanish origin? 
Yes     No    Prefer not to answer