Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma (AWARE)

Lifespan

Status: Active, not recruiting

Conditions: Sexual Assault; Sexual Dysfunction; Alcohol Use, Unspecified

Treatments: Behavioral: AWARE

Study type: Interventional

Funder types: Other

Identifiers

NCT05599620

R34AA028402

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. be between the ages of 18 and 24;
2. speak and comprehend English;
3. 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;
4. report exceeding the national recommended limits for daily drinking (4 or more for women) on one or more occasions in the past 6 months;
5. report past year sexual activity;
6. 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)

Exclusion criteria

1. suicide risk on items from the Beck Depression Inventory;
2. screen positive on the Alcohol Use Withdrawal Checklist.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

AWARE Program

Experimental group

Description:

The AWARE program addresses alcohol use, sexual distress and sexual revictimization risk.

Treatment:

Behavioral: AWARE

Control Group

No Intervention group

Description:

The comparison is a wait list control group.