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为大学生量身定制综合酒精与危险性行为反馈:1型混合有效性-实施试验方案

Cross-Tailoring Integrative Alcohol and Risky Sexual Behavior Feedback for College Students: Protocol for a Hybrid Type 1 Effectiveness-Implementation Trial.

作者信息

Ray Anne E, Mun Eun-Young, Lewis Melissa A, Litt Dana M, Stapleton Jerod L, Tan Lin, Buller David B, Zhou Zhengyang, Bush Heather M, Himelhoch Seth

机构信息

Department of Health, Behavior & Society, College of Public Health, University of Kentucky, Lexington, KY, United States.

Department of Health Behavior and Health Systems, School of Public Health, The University of North Texas Health Science Center at Fort Worth, Fort Worth, TX, United States.

出版信息

JMIR Res Protoc. 2023 Mar 20;12:e43986. doi: 10.2196/43986.

Abstract

BACKGROUND

Underage drinking and related risky sexual behavior (RSB) are major public health concerns on United States college campuses. Although technology-delivered personalized feedback interventions (PFIs) are considered a best practice for individual-level campus alcohol prevention, there is room for improving the effectiveness of this approach with regard to alcohol-related RSB.

OBJECTIVE

The aims of this study are to (1) evaluate the impact of a brief PFI that integrates content on alcohol use and RSB and is adapted to include a novel cross-tailored dynamic feedback (CDF) component for at-risk first-year college students and (2) identify implementation factors critical to the CDF's success to facilitate future scale-up in campus settings.

METHODS

This study uses a hybrid type 1 effectiveness-implementation design and will be conducted in 3 phases. Phase 1 is a stakeholder-engaged PFI+CDF adaptation guided by focus groups and usability testing. In phase 2, 600 first-year college students who drink and are sexually active will be recruited from 2 sites (n=300 per site) to participate in a 4-group randomized controlled trial to examine the effectiveness of PFI+CDF in reducing alcohol-related RSB. Eligible participants will complete a baseline survey during the first week of the semester and follow-up surveys at 1, 2, 3, 6, and 13 months post baseline. Phase 3 is a qualitative evaluation with stakeholders to better understand relevant implementation factors.

RESULTS

Recruitment and enrollment for phase 1 began in January 2022. Recruitment for phases 2 and 3 is planned for the summer of 2023 and 2024, respectively. Upon collection of data, the effectiveness of PFI+CDF will be examined, and factors critical to implementation will be evaluated.

CONCLUSIONS

This hybrid type 1 trial is designed to impact the field by testing an innovative adaptation that extends evidence-based alcohol programs to reduce alcohol-related RSB and provides insights related to implementation to bridge the gap between research and practice at the university level.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05011903; https://clinicaltrials.gov/ct2/show/NCT05011903.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43986.

摘要

背景

未成年人饮酒及相关的危险性行为(RSB)是美国大学校园主要的公共卫生问题。尽管通过技术提供的个性化反馈干预措施(PFIs)被认为是校园酒精预防个人层面的最佳实践,但在与酒精相关的危险性行为方面,这种方法的有效性仍有提升空间。

目的

本研究的目的是:(1)评估一种简短的PFIs的影响,该干预措施整合了酒精使用和危险性行为的内容,并采用了一种新颖的交叉定制动态反馈(CDF)组件,针对有风险的大学一年级学生;(2)确定对CDF成功至关重要的实施因素,以促进未来在校园环境中的推广。

方法

本研究采用混合1型有效性-实施设计,分3个阶段进行。第1阶段是在焦点小组和可用性测试的指导下,由利益相关者参与的PFIs+CDF改编。在第2阶段,将从2个地点招募600名饮酒且有性行为的大学一年级学生(每个地点n = 300),参与4组随机对照试验,以检验PFIs+CDF在减少与酒精相关的危险性行为方面的有效性。符合条件的参与者将在学期的第一周完成基线调查,并在基线后1、2、3、6和13个月进行随访调查。第3阶段是与利益相关者进行定性评估,以更好地了解相关实施因素。

结果

第1阶段的招募和入组于2022年1月开始。第2阶段和第3阶段的招募计划分别在2023年和2024年夏季进行。收集数据后,将检验PFIs+CDF的有效性,并评估对实施至关重要的因素。

结论

这项混合1型试验旨在通过测试一种创新改编来影响该领域,这种改编扩展了基于证据的酒精项目,以减少与酒精相关的危险性行为,并提供与实施相关的见解,以弥合大学层面研究与实践之间的差距。

试验注册

ClinicalTrials.gov NCT05011903;https://clinicaltrials.gov/ct2/show/NCT05011903。

国际注册报告识别码(IRRID):DERR1-10.2196/43986。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cfea/10131715/57a11194ba62/resprot_v12i1e43986_fig1.jpg

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