Back to resultsReducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma (AWARE)
Primary Purpose
Alcohol Use, Unspecified, Sexual Dysfunction, Sexual Assault
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AWARE
General Health Promotion
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Use, Unspecified
Eligibility Criteria
Inclusion Criteria: be between the ages of 18 and 24; speak and comprehend English; report a history of attempted or completed penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via incapacitation or force; report exceeding the national recommended limits for daily drinking (4 or more for women) on two or more occasions in the past month; report past month sexual activity; exceed the clinical cut point on the Female Sexual Functioning Index. Exclusion Criteria: suicide risk on the Beck Depression Inventory; screen positive on the Alcohol Use Withdrawal Checklist.
Sites / Locations
- Rhode Island HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AWARE Program
General Health Promotion
Arm Description
The AWARE program addresses alcohol use, sexual distress and sexual revictimization risk.
The General Health Promotion program is a attention and dose-matched comparison condition.
Outcomes
Primary Outcome Measures
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.
Sexual Distress
Assessed via the Female Sexual Dysfunction Index, Minumum = 2, Maximum = 36 with higher scores meaning worse outcomes.
Sexual Victimization
Assessed via the Sexual Experiences Survey. Scored based on frequency and severity, Minumum = 0, Maximum = 63, higher scores means worse outcomes.
Secondary Outcome Measures
Sex-Related Drinking Motives
Assessed via 2 subscales of the Drinking Motives Questionnaire, Minimum = 8, Maximum
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05599620
Brief Title
Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma
Acronym
AWARE
Official Title
Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
April 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lifespan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use, Unspecified, Sexual Dysfunction, Sexual Assault
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AWARE Program
Arm Type
Experimental
Arm Description
The AWARE program addresses alcohol use, sexual distress and sexual revictimization risk.
Arm Title
General Health Promotion
Arm Type
Placebo Comparator
Arm Description
The General Health Promotion program is a attention and dose-matched comparison condition.
Intervention Type
Behavioral
Intervention Name(s)
AWARE
Intervention Description
AWARE addresses alcohol use, sexual distress, and sexual assault risk among college women with a history of sexual victimization.
Intervention Type
Behavioral
Intervention Name(s)
General Health Promotion
Intervention Description
General Health Promotion is an attention and dose matched intervention with no overlapping components with AWARE.
Primary Outcome Measure Information:
Title
Alcohol Use
Description
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.
Time Frame
Change from baseline alcohol use at 6 months.
Title
Sexual Distress
Description
Assessed via the Female Sexual Dysfunction Index, Minumum = 2, Maximum = 36 with higher scores meaning worse outcomes.
Time Frame
Change from overall levels of sexual dysfunction at 6 months.
Title
Sexual Victimization
Description
Assessed via the Sexual Experiences Survey. Scored based on frequency and severity, Minumum = 0, Maximum = 63, higher scores means worse outcomes.
Time Frame
Reductions in severity and frequency of victimization in comparison to control at 6 months.
Secondary Outcome Measure Information:
Title
Sex-Related Drinking Motives
Description
Assessed via 2 subscales of the Drinking Motives Questionnaire, Minimum = 8, Maximum
Time Frame
Change in sexual related drinking motives at 6 months.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The intervention enrolls cis-gender college women.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
be between the ages of 18 and 24;
speak and comprehend English;
report a history of attempted or completed penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via incapacitation or force;
report exceeding the national recommended limits for daily drinking (4 or more for women) on two or more occasions in the past month;
report past month sexual activity;
exceed the clinical cut point on the Female Sexual Functioning Index.
Exclusion Criteria:
suicide risk on the Beck Depression Inventory;
screen positive on the Alcohol Use Withdrawal Checklist.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay Orchowski
Phone
4125592936
Email
lindsay_orchowski@brown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Prachi Bhiptani
Email
prachi_bhuptani@brown.edu
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay M Orchowski, Ph.D.
Phone
401-444-7021
Email
Lindsay_Orchowski@brown.edu
First Name & Middle Initial & Last Name & Degree
Lindsay M Orchowski, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma
We'll reach out to this number within 24 hrs