Protocol for COACH, an evidence-based intervention for improved head impact safety in youth American football developed using a community-engaged approach

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-09-17 DOI:10.1016/j.conctc.2024.101371
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Abstract

Subconcussive, repetitive head impacts sustained in collision sports may negatively affect brain health. American football practices are controlled environments amenable to intervention. Engaging community members is essential for successful development, implementation, and sustainability of viable interventions. The objective of this study is to develop and pilot test an evidence-based intervention to reduce head impact exposure in youth American football (i.e., football), using a community-engaged approach. This manuscript describes the co-design of the intervention and associated implementation plan and the study protocol for evaluating the effectiveness and feasibility of the intervention and implementation plan. In the first part of this study, focus groups with parents and coaches, and individual interviews with organizational leaders associated with two teams at the middle school level were conducted. An anonymous survey assessing beliefs and perceptions of non-concussive head impacts was given to parents, coaches, and organizational leaders within the local youth football league. Following the football season, qualitative and quantitative data describing determinants of head acceleration events in football were shared with 12 stakeholders of coaches, league and school administrators, parents, an athletic trainer, and local university player development director. Together, we co-designed COACH (COmmunities Aligned to reduce Concussion and Head impact exposure) and implementation plan using a strategic planning approach. The preliminary effectiveness and feasibility were assessed in the second part of this study. Youth football players participating on the teams in year 1 (control teams) were fitted with mouthpiece-based head kinematic sensors which measure head acceleration events (HAEs). HAEs were collected and quantified during team activities. Preliminary effectiveness of the intervention to reduce HAEs was measured among two new teams pilot testing COACH with mouthpiece-based sensors, while simultaneously monitoring implementation of the intervention. We report our study design and evaluation, and opportunities and challenges with our approach. The results will inform a future full-scale pragmatic trial to assess the implementation and effectiveness of the intervention program.

NCT04908930.

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COACH 协议,这是一项以证据为基础的干预措施,旨在通过社区参与的方式改善青少年美式橄榄球的头部撞击安全。
碰撞运动中头部受到的次撞击和重复撞击可能会对大脑健康产生负面影响。美式橄榄球训练是一种可控环境,适合采取干预措施。社区成员的参与对于可行干预措施的成功开发、实施和可持续性至关重要。本研究的目的是采用社区参与的方法,开发并试点测试一种循证干预措施,以减少青少年美式橄榄球(即足球)运动中的头部撞击。本手稿介绍了干预措施和相关实施计划的共同设计,以及评估干预措施和实施计划的有效性和可行性的研究方案。在研究的第一部分,对家长和教练进行了焦点小组讨论,并对与中学两支球队相关的组织领导进行了个别访谈。此外,还向当地青少年足球联赛的家长、教练和组织领导者发放了一份匿名调查问卷,评估他们对非撞击性头部撞击的信念和看法。足球赛季结束后,我们与教练、联赛和学校管理人员、家长、运动训练师和当地大学球员发展主任等 12 名利益相关者分享了描述足球运动中头部加速事件决定因素的定性和定量数据。我们采用战略规划方法,共同设计了 COACH(减少脑震荡和头部撞击的社区联盟)和实施计划。本研究的第二部分对初步的有效性和可行性进行了评估。参加第一年级球队(对照组)的青少年足球运动员都安装了口罩式头部运动传感器,用于测量头部加速度事件(HAE)。在球队活动中收集并量化 HAEs。在两支新队伍中,对使用口罩式传感器的 COACH 进行了试点测试,同时对干预措施的实施情况进行了监测,以衡量干预措施在减少 HAE 方面的初步效果。我们报告了我们的研究设计和评估,以及我们的方法所面临的机遇和挑战。研究结果将为未来的全面务实试验提供参考,以评估干预计划的实施情况和有效性。
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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