Integrated Alcohol and Sexual Assault Prevention for Bisexual Women

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 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.

Official Title
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Integrated Alcohol and Sexual Assault Prevention for Bisexual Women

Conditions
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Alcohol Use, Unspecified, Sexual Assault

Intervention / Treatment
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* Behavioral: REACH Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: current suicide risk on the Beck Depression Inventory current symptoms of alcohol use withdrawal 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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All

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: REACH Program<br>The REACH program addresses alcohol use, sexual assault risk, and experiences relating to experiences of harm among bisexual women. | Behavioral: REACH Program<br>* The REACH program addresses alcohol use, sexual assault risk, and experiences relating to harm among bisexual women.<br>|
| No Intervention: Wait List Control Group<br>The Wait List Control Group will have the opportunity to complete the REACH program after completing study assessments at the 4-month follow-up. | |

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 (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) | Change from baseline alcohol use at 4 months. | 
| Sexual Victimization | Assessed via the Sexual Experiences Survey. Summary score calculated that reflects both frequency and severity (Minimum = 0, Maximum = 63). Higher scores mean worse outcomes. | Reductions in comparison to control at 4 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Assessed via the Generalized Anxiety Disorder 7 (GAD-7) (Minimum = 0, Maximum = 21), with higher scores meaning worse outcomes. | Change from baseline at 4-months. | 
| Depression | Assessed via the Patient Health Questionnaire 9 (PHQ-9) (Minimum = 0, Maximum = 27), with higher scores meaning worse outcomes. | Change from baseline at 4-months. | 
| Mindfulness | Assessed via the Mindful Attention and Awareness Scale (Minimum = 15, Maximum = 90), with higher scores meaning better outcomes. | Change from baseline at 4-months. |