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临床试验/NCT05180539
NCT05180539已完成不适用

A Multi-Component Alcohol and Sex Risk Intervention for College Students

Lehigh University2 个研究点 分布在 1 个国家目标入组 274 人开始时间: 2021年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
274
试验地点
2
主要终点
Primary Outcome: Program Satisfaction as Assessed by the Acceptance Questionnaire After First Intervention Session

研究概览

简要总结

Hazardous alcohol use, sexually transmitted infections, and sexual violence are interrelated and highly prevalent public health concerns in college student populations. The current study seeks to develop a tri-pronged sex-positive intervention that addresses risky alcohol use, unsafe sex, and sexual violence for college men and women (ages 18-24). The study involves a small randomized pilot trial to demonstrate the feasibility and acceptability of the recruitment methods and research design. Preliminary evidence of intervention efficacy will also be evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Must be student at the site university

排除标准

  • Students who have participated in relevant site specific studies will be excluded

结局指标

主要结局

Primary Outcome: Program Satisfaction as Assessed by the Acceptance Questionnaire After First Intervention Session

时间窗: Immediate post intervention (same day as intervention), after first session on day 1

Satisfaction with the program content after Session 1. Percent of participants reporting they were moderately-to-very satisfied with the program.

Program Satisfaction as Assessed by the Acceptance Questionnaire After Second Session

时间窗: Immediate post intervention (same day as intervention), after second session on ~Day 14

Satisfaction with the program content after session 2. Percent of participants reporting that they were moderately-to-very satisfied with the program. For participants who did not attend the first session this occurred on Day 1. For Participants who did attend the first session this occurred around Day 14 (range between day 12 and 17)

Heavy Alcohol Use

时间窗: Change from baseline to 6 month follow-up

Number of standard drinks consumed in a typical week over the past 30 days

Alcohol Use Before or During Sex

时间窗: Change from baseline to 6 month follow-up

Participants reported if they drank alcohol before or during sex in the past 30 days (code as yes = 1 or no = 0).

Bystander Behaviors Willingness Questionnaire

时间窗: Change from baseline to 6 month follow-up

Willingness to engage in bystander behaviors. Mean scale scores range from 1 to 7. Higher scores indicate more greater willingness to engage in bystander behaviors.

Bystander Behaviors Self-efficacy Questionnaire

时间窗: Change from baseline to 6 month follow-up

Confidence to engage in bystander behaviors. Higher scores indicate more greater confidence in ability to engage in bystander behaviors. Mean scale scores range from 1 to 5.

次要结局

  • Alcohol and Sex Related Protective Behavioral Strategies Use(Change from baseline to 6 month follow-up)
  • Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form(Change from baseline to 6 month follow-up)
  • Perceived Student Sex Norms as Assessed by a Sex Norms Questionnaire(Change from baseline to 6 month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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