Protocol for COACH, an evidence-based intervention for improved head impact safety in youth American football developed using a community-engaged approach
{"title":"Protocol for COACH, an evidence-based intervention for improved head impact safety in youth American football developed using a community-engaged approach","authors":"","doi":"10.1016/j.conctc.2024.101371","DOIUrl":null,"url":null,"abstract":"<div><p>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.</p><p>NCT04908930.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4000,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001182/pdfft?md5=83c04fcea6ccc6dcb01c52415fa91438&pid=1-s2.0-S2451865424001182-main.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865424001182","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
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.
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.