Integrated Alcohol and Sexual Assault Prevention for Bisexual Women
概览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Lifespan
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Alcohol Use
概览
简要总结
The goal of this clinical trial is to develop and evaluate the preliminary efficacy of an intervention to address reducing alcohol use, sexual revictimization, and psychological distress among bisexual+ women (i.e., attraction to more than one gender: bisexual, pansexual, queer). The main questions the study seeks to answer are: 1) what is the feasibility of the recruitment method, research design, interventionist training methods, and delivery of the intervention; 2) does the intervention, relative to control, at the 2- and 4-month follow-up period, produce reductions in the quantity and frequency of alcohol use, sexual victimization, and psychological distress (anxiety, depression). Follow-up assessments are completed at 2- and 4-months following program completion. The intervention is compared to a wait list control group.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be between the ages of 18 and 24 years of age;
- •identify as female gender or fluid, or gender non-conforming, gender queer, or non-binary
- •identify as bisexual+ (i.e., attraction to more than one gender: bisexual, pansexual, queer);
- •report a history of attempted or completed penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via coercion, incapacitation or force;
- •report exceeding the national recommended limits for daily drinking (4 or more for women) on two or more occasions in the past month;
- •report past month sexual activity.
排除标准
- •current suicide risk on the Beck Depression Inventory
- •current symptoms of alcohol use withdrawal on the Alcohol Use Withdrawal Checklist
结局指标
主要结局
Alcohol Use
时间窗: Change from baseline alcohol use at 4 months.
The number of past month drinking days (Minimum = 0, Maximum = 31), average drinks per drinking day (Minimum = 0, Maximum = unspecified), number of heavy drinking days (Minimum = 0, Maximum = 30), assessed via the Time Line Follow Back, with greater scores meaning worse outcomes)
Sexual Victimization
时间窗: Reductions in comparison to control at 4 months.
Assessed via the Sexual Experiences Survey. Summary score calculated that reflects both frequency and severity (Minimum = 0, Maximum = 63). Higher scores mean worse outcomes.
次要结局
- Anxiety(Change from baseline at 4-months.)
- Depression(Change from baseline at 4-months.)
- Mindfulness(Change from baseline at 4-months.)
研究者
Lindsay Orchowski Ph.D.
Associate Professor (Research)
Lifespan