Development of an Alcohol, Cannabis, and Sexual Assault Risk Reduction Program for High Risk College Women, Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cannabis Use Frequency Measured at Follow-Ups
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study determined at pre-screening
- •Between the ages of 18-24 years old determined at pre-screening
- •Identifies as a woman determined at pre-screening
- •Is currently enrolled as an undergraduate in Colorado with a valid student email address determined at pre-screening
- •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
- •Engaged in using cannabis at least once in the past month with an intention to use in the future determined at pre-screening
- •Is available to attend sessions on specific dates
- •Has a phone they can complete web-based surveys on determined at pre-screening
排除标准
- •1. There are no exclusion criteria aside from not meeting inclusion criteria.
研究组 & 干预措施
Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program
干预措施: Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program (Behavioral)
Assessment Only Control
干预措施: Assessment Only Control (Behavioral)
结局指标
主要结局
Cannabis Use Frequency Measured at Follow-Ups
时间窗: 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.
Heavy Episodic Drinking Frequency Measured at Follow-Ups
时间窗: 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.
Attempted Sexual Assault Measured at Follow-Ups
时间窗: 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.
Completed Sexual Assault Measured at Follow-Ups
时间窗: 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.
次要结局
未报告次要终点