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Development of an Alcohol, Cannabis, and Sexual Assault Risk Reduction Program for High Risk College Women

2026年7月21日 更新者：University of Colorado, Denver

Development of an Alcohol, Cannabis, and Sexual Assault Risk Reduction Program for High Risk College Women, Pilot RCT

The goal of this clinical trial is to assess the feasibility of the Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program with alcohol and cannabis content (EAAA+) in undergraduate college women between ages 18-24 years old who use alcohol and cannabis. The main objectives it aims to answer are:

  • To determine the feasibility of a randomized controlled trial comparing EAAA+ to an assessment only control condition.
  • To determine if EAAA+ will result in larger decreases in HED and cannabis use, more accurate perceptions of alcohol and cannabis norms, and greater increases in PBS at follow up.
  • To determine if EAAA+ will result in (1) greater increases in SA risk perception and use of assertive SA resistance strategies and (2) decreased barriers to SA resistance while using alcohol and cannabis, and (3) greater reductions in incapacitated SA.

Researchers will compare participants who received EAAA+ to an assessment only condition to test the objectives stated above.

Participants will:

  • Sign an informed consent form and complete a survey. Once the survey is completed, they will be randomly assigned to complete the sexual assault education program or not.
  • Participants assigned to the sexual assault education program will complete two in-person sessions (about 7 hours each) or four in-person sessions (about 3.5 hours each) and will also complete an online module in between modules 2 and 3 as part of the education program and complete four short surveys.
  • Complete 4 weeks of assessments and complete a follow-up survey at 1, 3, and 6 months after the initial session.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado Anschutz Medical Campus
        • 接触：
        • 首席研究员：
          • Ruschelle M Leone, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study determined at pre-screening
  3. Between the ages of 18-24 years old determined at pre-screening
  4. Identifies as a woman determined at pre-screening
  5. Is currently enrolled as an undergraduate in Colorado with a valid student email address determined at pre-screening
  6. Engaged in heavy episodic drinking (i.e., 4+ drinks within a two-hour period) at least once in the past month with an intention to drink in the future determined at pre-screening
  7. Engaged in using cannabis at least once in the past month with an intention to use in the future determined at pre-screening
  8. Is available to attend sessions on specific dates
  9. Has a phone they can complete web-based surveys on determined at pre-screening

Exclusion Criteria:

1. There are no exclusion criteria aside from not meeting inclusion criteria.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program
行为的：Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program
Participants will be randomized to EAAA+, a combined program for alcohol and cannabis prevention and sexual assault risk reduction.
有源比较器：Assessment Only Control
行为的：Assessment Only Control
Participants will be randomized to an assessment only control.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Cannabis Use Frequency Measured at Follow-Ups
大体时间：Up to 1-month, 3-months, and 6-months post intervention
Cannabis use frequency will be reported using a self-report at 1-month and 3- and 6-month follow ups.
Up to 1-month, 3-months, and 6-months post intervention
Heavy Episodic Drinking Frequency Measured at Follow-Ups
大体时间：Up to 1-month, 3-months, and 6-months post intervention
Heavy episodic drinking (HED) frequency will be reported using a self-report at 1-month and 3- and 6-month follow ups.
Up to 1-month, 3-months, and 6-months post intervention
Attempted Sexual Assault Measured at Follow-Ups
大体时间：Up to 1-month, 3-months, and 6-months post intervention
Attempted sexual assault will be reported using a self-report at 1-month and 3- and 6-month follow ups.
Up to 1-month, 3-months, and 6-months post intervention
Completed Sexual Assault Measured at Follow-Ups
大体时间：Up to 1-month, 3-months, and 6-months post intervention
Completed sexual assault will be reported using a self-report at 1-month and 3- and 6-month follow ups.
Up to 1-month, 3-months, and 6-months post intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Colorado, Denver

合作者

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年2月1日

研究完成 (估计的)

2027年2月1日

研究注册日期

首次提交

2026年7月21日

首先提交符合 QC 标准的

2026年7月21日

首次发布 (实际的)

2026年7月24日

研究记录更新

最后更新发布 (实际的)

2026年7月24日

上次提交的符合 QC 标准的更新

2026年7月21日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 24-2079
  • K01AA028844 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

IPD will be available in the NIAAA Data Archive.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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