Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma

NCT05599620 — Not applicable, Completed, 86 participants, Lifespan

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT05599620, acronym AWARE
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, prevention
Enrollment	86 (Actual)
Sponsor	Lifespan (Other)
Conditions	Alcohol Use, Unspecified, Sexual Dysfunction, Sexual Assault
Interventions	AWARE (Behavioral)
Dates	start 2023-02-14, primary completion 2026-03-30, completion 2026-03-30, first posted 2022-10-31, last updated 2026-04-29
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
AWARE Program	Experimental	Behavioral: AWARE	The AWARE program addresses alcohol use, sexual distress and sexual revictimization risk.
Control Group	No intervention		The comparison is a wait list control group.

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

+Outcome measures

Primary outcomes

Alcohol Use [Change from baseline alcohol use at 4 months.]: 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.
Sexual Distress [Change from overall levels of sexual dysfunction at 4 months.]: 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.
Sexual Victimization [Reductions in severity and frequency of victimization in comparison to control at 4 months.]: Assessed via the Sexual Experiences Survey. Scored based on frequency and severity, Minumum = 0, Maximum = 63, higher scores means worse outcomes.

Secondary outcomes

Sex-Related Drinking Expectancies [Change in sexual related drinking expectancies at 4 months.]: Assessed via the Sex Related Alcohol Expectancies, Minimum = 14, Maximum = 70

+Eligibility

Sex: Female, ages: 18 Years to 24 Years, 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.

+Locations (1)

Facility	City	Country	Status
Rhode Island Hospital	Providence, Rhode Island	United States