Health TrialsbyHealthPanel

COmmunities Aligned to Reduce Concussion and Head Impact Exposure

ConditionConcussions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-14
SponsorWake Forest University Health Sciences

About this trial

Head impacts in collision sports such as football are a public health concern, as repetitive head impacts, even if a concussion is not suspected, have negative effects on brain health. This study has partnered with a community stakeholder group to create a safety program for youth football named "COmmunities Aligned to reduce Concussion and Head impact exposure (COACH)", which seeks to improve knowledge and skills of youth coaches in effective and safe practice planning and to change attitudes and beliefs to prevent head impacts and promote safety. To continue advancing COACH as an approach to prevent head injuries in youth football, this R01 Research Project Grant will determine the ability of youth football organizations to adopt COACH and test if COACH is effective in reducing head impacts, concussion, and negative effects of brain health while monitoring how the program is implemented.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants without braces

Disqualifiers

Athletes will be excluded from participation if they currently have braces or plan to have braces during the football season, or have dental appliances that may impede the fit of the mouthpiece device (e.g., Herbst Appliance).

Trial design

Design model

Single group

Treatments tested in this trial

  • COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) Intervention

    Behavioral

    COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) includes use of practice plans and a resource booklet aligned with the National Federation for High School guidelines for contact in practice. Coaches will also attend a pre-season coaches' clinic and be paired with a peer mentor during the season.

Treatment groups

880 Participants
are divided into 1 treatment group
Group A: practice interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of practice impacts

Total number of head impacts measured during the season in practices - 0-500 impacts

Time frame
3 months
2

linear acceleration of practice impacts

Median peak resultant linear acceleration measured during the season in practices - 8-45 g of linear acceleration

Time frame
3 months
3

rotational acceleration of practice impacts

Median peak resultant rotational acceleration measured during the season in practices - Median peak resultant linear acceleration measured during the season in practices - 8-45 g of linear acceleration - 100-1500 rad/s\^2

Time frame
3 months
4

Change in verbal memory composite (ImPACT) scores

Pre- to post-season change in attentional processes, learning, and memory within the verbal domain - range: 60-100; The composite score represents the average performance across three subtasks. A higher score indicates better performance.

Time frame
3 months

Secondary outcomes

1

Intervention fidelity percentage of implementation

Implementation score representing the percentage of practices the intervention was implemented as prescribed - 0-100% - higher percent denoting more implementation

Time frame
3 months
2

Adaptation of the intervention (AIM) score

5-point Likert scale of the acceptability of the intervention - 0-5 - higher scores denoting more adaptation

Time frame
pre-season
3

Feasibility of the Intervention (FIM) score

5-point Likert scale of the feasibility of the intervention - 0-5 - higher scores denoting higher feasibility

Time frame
pre-season

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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