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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05599620
Other study ID # R34AA028402
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 14, 2023
Est. completion date April 30, 2026

Study information

Verified date February 2024
Source Lifespan
Contact Lindsay Orchowski
Phone 4125592936
Email lindsay_orchowski@brown.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 6-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 6-months following program completion. The intervention will be compared to a general health promotion control group.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date April 30, 2026
Est. primary completion date April 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 24 Years
Eligibility 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 acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via incapacitation or force; 4. report exceeding the national recommended limits for daily drinking (4 or more for women) on two or more occasions in the past month; 5. report past month sexual activity; 6. exceed the clinical cut point on the Female Sexual Functioning Index. Exclusion Criteria: 1. suicide risk on the Beck Depression Inventory; 2. screen positive on the Alcohol Use Withdrawal Checklist.

Study Design


Intervention

Behavioral:
AWARE
AWARE addresses alcohol use, sexual distress, and sexual assault risk among college women with a history of sexual victimization.
General Health Promotion
General Health Promotion is an attention and dose matched intervention with no overlapping components with AWARE.

Locations

Country Name City State
United States Rhode Island Hospital Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Lifespan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months.
Primary Sexual Distress Assessed via the Female Sexual Dysfunction Index, Minumum = 2, Maximum = 36 with higher scores meaning worse outcomes. Change from overall levels of sexual dysfunction at 6 months.
Primary 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 6 months.
Secondary Sex-Related Drinking Motives Assessed via 2 subscales of the Drinking Motives Questionnaire, Minimum = 8, Maximum Change in sexual related drinking motives at 6 months.
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