COmmunities Aligned to Reduce Concussion and Head Impact Exposure

Официальное название

COmmunities Aligned to Reduce Concussion and Head Impact Exposure (COACH)

Обзор

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.

Подробное описание

Football has a high risk of concussion and incidence of subconcussive head impacts which have long-lasting negative effects on brain health. With roughly 3.5 million athletes participating in youth football each year, there is a critical need to reduce head impact exposure and concussion risk. Over an entire season, most of an athlete's head impact exposure is attributed to practice. Coach-directed activities (e.g., practice drills) influence the frequency and severity of head impact exposure. Practices are amenable to intervention; however, youth football leagues are often community-run organizations with limited resources, making implementation and enforcement of injury prevention strategies a challenge. Thus, engaging community members is essential for successful development, implementation, and sustenance of interventions. This study partnered with a community stakeholder group to co-design and implement an evidence-based intervention program: COmmunities Aligned to reduce Concussion and Head impact exposure (COACH). COACH seeks to improve knowledge and skills of youth football coaches in effective practice planning that incorporates safe drills and to change attitudes and beliefs toward contact in practice. COACH has been pilot tested in two teams and shown to be acceptable and feasible. A critical next step of this research is the pragmatic evaluation of the effectiveness of COACH on a larger scale, while identifying factors that influence implementation. This study addresses this critical next step by determining the capacity of youth football organizations to adopt COACH and by testing COACH's effectiveness while monitoring the implementation process.

Вмешательства

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

Первичные конечные точки

• Number of practice impacts [Срок оценки: 3 months]
• linear acceleration of practice impacts [Срок оценки: 3 months]
• rotational acceleration of practice impacts [Срок оценки: 3 months]
• Change in verbal memory composite (ImPACT) scores [Срок оценки: 3 months]
• Change in visual memory composite (ImPACT) scores [Срок оценки: 3 months]
• Change in visual motor speed composite (ImPACT) scores [Срок оценки: 3 months]
• Change in reaction time composite (ImPACT) scores [Срок оценки: 3 months]
• Change in Flanker Task (NIH Toolbox) Scores [Срок оценки: 3 months]
• Change in pattern comparison (NIH Toolbox) Scores [Срок оценки: 3 months]
• Change in list sorting (NIH Toolbox) Scores [Срок оценки: 3 months]

Вторичные конечные точки (3)

• Intervention fidelity percentage of implementation [Срок оценки: 3 months]
• Adaptation of the intervention (AIM) score [Срок оценки: pre-season]
• Feasibility of the Intervention (FIM) score [Срок оценки: pre-season]

Критерии участия

Критерии включения

• Participants without braces

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Wake Forest University Health Sciences — Winston-Salem

Идентификаторы

NCT: NCT06624202 · IRB00119368 · R01HD116966

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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