Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma

Study Overview
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Brief Summary
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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 6-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 6-months following program completion. The intervention will be compared to a general health promotion control group.

Official Title
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Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma

Conditions
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Alcohol Use, Unspecified, Sexual Dysfunction, Sexual Assault

Intervention / Treatment
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* Behavioral: AWARE
* Behavioral: General Health Promotion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be between the ages of 18 and 24; speak and comprehend English; report a history of attempted or completed penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via 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; exceed the clinical cut point on the Female Sexual Functioning Index. Exclusion Criteria: suicide risk on the Beck Depression Inventory; screen positive on the Alcohol Use Withdrawal Checklist.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AWARE Program<br>The AWARE program addresses alcohol use, sexual distress and sexual revictimization risk. | Behavioral: AWARE<br>* AWARE addresses alcohol use, sexual distress, and sexual assault risk among college women with a history of sexual victimization.<br>|
| Placebo Comparator: General Health Promotion<br>The General Health Promotion program is a attention and dose-matched comparison condition. | Behavioral: General Health Promotion<br>* General Health Promotion is an attention and dose matched intervention with no overlapping components with AWARE.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol Use | 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. | Change from baseline alcohol use at 6 months. | 
| Sexual Distress | Assessed via the Female Sexual Dysfunction Index, Minumum = 2, Maximum = 36 with higher scores meaning worse outcomes. | Change from overall levels of sexual dysfunction at 6 months. | 
| Sexual Victimization | Assessed via the Sexual Experiences Survey. Scored based on frequency and severity, Minumum = 0, Maximum = 63, higher scores means worse outcomes. | Reductions in severity and frequency of victimization in comparison to control at 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sex-Related Drinking Motives | Assessed via 2 subscales of the Drinking Motives Questionnaire, Minimum = 8, Maximum | Change in sexual related drinking motives at 6 months. |