Integrated Alcohol and Sexual Assault Prevention for Bisexual Women

Lifespan

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Conditions

Alcohol Use, Unspecified Sexual Assault

Interventions

REACH ProgramBEHAVIORAL

The REACH program addresses alcohol use, sexual assault risk, and experiences relating to harm among bisexual women.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 24 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rhode Island Hospital

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

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)

Time frame: 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.

Time frame: Reductions in comparison to control at 4 months.

Secondary Outcomes

Anxiety

Assessed via the Generalized Anxiety Disorder 7 (GAD-7) (Minimum = 0, Maximum = 21), with higher scores meaning worse outcomes.

Time frame: 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.

Time frame: 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.

Time frame: Change from baseline at 4-months.

Data from ClinicalTrials.gov

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