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

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.

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunction; Alcohol Use, Unspecified; Sexual Assault
• Intervention / Treatment: Behavioral: AWARE

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AWARE Program; The AWARE program addresses alcohol use, sexual distress and sexual revictimization risk.	Behavioral: AWARE; AWARE addresses alcohol use, sexual distress, and sexual assault risk among college women with a history of sexual victimization.
No Intervention: Control Group; The comparison is a wait list control group.

What is the study measuring?

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 4 months.
Sexual Distress	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.	Change from overall levels of sexual dysfunction at 4 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 4 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex-Related Drinking Expectancies	Assessed via the Sex Related Alcohol Expectancies, Minimum = 14, Maximum = 70	Change in sexual related drinking expectancies at 4 months.

Collaborators and Investigators

• Sponsor: Lifespan

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Actual): March 30, 2026
• Study Completion (Actual): March 30, 2026

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Drinking Behavior; Behavior; Alcohol Drinking; Sexual Dysfunction, Physiological
• Other Study ID Numbers: R34AA028402 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared using the National Institute of Mental Health Data Archive (NDA).
• IPD Sharing Time Frame: The research team will submit data on or before the NDA submission due dates (April 1 and October 1 each year) in accordance with the applicable Data Sharing Terms and Conditions of award.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No