Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma

NCT05599620 | Completed DMC

• 1 other identifier: R34AA028402
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use, Unspecified; Sexual Dysfunction; Sexual Assault

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Sex-Related Drinking Expectancies

  Change in sexual related drinking expectancies at 4 months.

Study Arms (2)

AWARE Program

EXPERIMENTAL

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

Behavioral: AWARE

Control Group

NO INTERVENTION

The comparison is a wait list control group.

Interventions

AWARE BEHAVIORAL

AWARE addresses alcohol use, sexual distress, and sexual assault risk among college women with a history of sexual victimization.

AWARE Program

Eligibility Criteria

• Age: 18 Years - 24 Years
• Gender Eligibility Details: The intervention enrolls cis-gender college women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lifespan: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02904, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Research)

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 31, 2022
• Study Start: February 14, 2023
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.

Locations

US (1)