Maximizing the reach of universal child sexual abuse prevention: Protocol for an equivalence trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-07-31 DOI:10.1016/j.conctc.2024.101345
Kate Guastaferro , Mia S. Melchior , Siyu Heng , Jessica Trudeau , Jacqueline L. Holloway
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Abstract

Background

Child sexual abuse (CSA) affects 1 in 5 girls and 1 in 12 boys before age 18. Universal school-based prevention programs are an effective and cost-efficient method of teaching students an array of personal safety skills. However, the programmatic reach of universal school-based programs is limited by the inherent reliance on the school infrastructure and a dearth of available alternative delivery modalities.

Methods

The design for this study will use a rigorous cluster randomized design (N = 180 classrooms) to determine the equivalence of two delivery modalities of Safe Touches: as usual vs. modified. The as usual workshop will be delivered by two facilitators with live puppet skits (n = 90). Whereas, the modified workshop will be delivered by one facilitator using prerecorded skit videos (n = 90). We will determine the equivalence by measuring concept learning acquisition preworkshop to immediate postworkshop (Aim 1) and retention at 3-months postworkshop (Aim 2) among students in classrooms that receive the as usual or modified workshops. To conclude equivalence, it is imperative to also examine factors that may impact future dissemination and implementation, specifically program adoption among school personnel and implementation fidelity between the two modalities (Aim 3).

Conclusion

Study findings will inform the ongoing development of effective CSA prevention programs and policy decisions regarding the sustainable integration of such programs within schools.

Clinical trial registration

NCT06195852.

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最大限度地普及儿童性虐待预防措施:等效试验方案
背景儿童性虐待(CSA)影响着 18 岁前五分之一的女孩和十二分之一的男孩。普及校本预防计划是教授学生一系列个人安全技能的有效且经济的方法。本研究将采用严格的分组随机设计(N = 180 间教室),以确定 "安全触摸 "的两种授课方式的等效性:照常授课与改良授课。常规工作坊将由两名主持人以木偶剧的形式进行(人数=90)。而修改后的工作坊将由一名主持人使用预先录制的短剧视频进行讲授(人数 = 90)。我们将通过测量工作坊前和工作坊后学生的概念学习掌握情况(目标 1)以及工作坊后 3 个月学生的概念学习保持情况(目标 2)来确定工作坊的等效性。为了得出等效性结论,还必须研究可能影响未来传播和实施的因素,特别是学校工作人员对项目的采纳情况以及两种模式之间的实施保真度(目标 3)。结论研究结果将为有效的 CSA 预防项目的持续发展以及有关在学校内可持续整合此类项目的政策决策提供信息。
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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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