Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Lifespan
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Alcohol Use
研究概览
简要总结
The goal of this clinical trial is to develop and evaluate the preliminary efficacy of an intervention to address alcohol use, sexual distress, and sexual assault risk among college women with a history of sexual victimization. The main questions it aims 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, relatively to control, the 2- and 4-month follow-up produces reductions in the quantity/frequency of alcohol use and heavy drinking, sexual distress, and sex-related drinking motives, and sexual revictimization. Participants will engage in both individual and group based intervention for alcohol use, sexual distress, and sexual assault risk. Follow-up assessments are completed at 2- and 4-months following program completion. The intervention is compared to a wait list control group who will have the opportunity to complete the program after completing the 4-month follow up.
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
- Female
- 接受健康志愿者
- 是
入选标准
- •be between the ages of 18 and 24;
- •speak and comprehend English;
- •report a history of attempted or completed penetrative or non-penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via incapacitation, coercion, or force;
- •report exceeding the national recommended limits for daily drinking (4 or more for women) on one or more occasions in the past 6 months;
- •report past year sexual activity;
- •exceed the clinical cut point on the Female Sexual Functioning Index (score of 28.1 or lower) or exceed the cut point for the 13-item Female Sexual Distress Scale-Revised (score of 11 or higher)
排除标准
- •suicide risk on items from the Beck Depression Inventory;
- •screen positive on the Alcohol Use Withdrawal Checklist.
研究组 & 干预措施
Control Group
The comparison is a wait list control group.
AWARE Program
The AWARE program addresses alcohol use, sexual distress and sexual revictimization risk.
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 (Minmum = 0, Maximum = 30), average drinks per drinking day (Minmum = 0, Maximum = unspecificed), number of heavy drinking days (Minimum = 0, Maximum = 30), assessed via the Time Line Follow Back, with greater scores meaning worse outcomes.
Sexual Distress
时间窗: Change from overall levels of sexual dysfunction at 4 months.
Assessed via the Female Sexual Dysfunction Index, Minimum = 2, Maximum = 36 with higher scores meaning worse outcomes, and the Female Sexual Distress Scale, Minimum = 0, Maximum = 52 with lower scores meaning worse outcomes.
Sexual Victimization
时间窗: Reductions in severity and frequency of victimization in comparison to control at 4 months.
Assessed via the Sexual Experiences Survey. Scored based on frequency and severity, Minumum = 0, Maximum = 63, higher scores means worse outcomes.
次要结局
- Sex-Related Drinking Expectancies(Change in sexual related drinking expectancies at 4 months.)
研究者
Lindsay Orchowski Ph.D.
Professor (Research)
Lifespan