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Integrated Alcohol and Sexual Assault Prevention for Bisexual Women

Primary Purpose

Alcohol Use, Unspecified, Sexual Assault

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
REACH Program
Sponsored by
Lifespan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Use, Unspecified

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: be between the ages of 18 and 24 years of age; identify as female gender or fluid, or gender non-conforming, gender queer, or non-binary identify as bisexual+ (i.e., attraction to more than one gender: bisexual, pansexual, queer); report a history of attempted or completed penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via coercion, 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. Exclusion Criteria: current suicide risk on the Beck Depression Inventory current symptoms of alcohol use withdrawal on the Alcohol Use Withdrawal Checklist

Sites / Locations

  • Rhode Island HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

REACH Program

Wait List Control Group

Arm Description

The REACH program addresses alcohol use, sexual assault risk, and experiences relating to experiences of harm among bisexual women.

The Wait List Control Group will have the opportunity to complete the REACH program after completing study assessments at the 4-month follow-up.

Outcomes

Primary Outcome Measures

Alcohol Use
The number of past month drinking days (Minimum = 0, Maximum = 31), average drinks per drinking day (Minimum = 0, Maximum = unspecified), number of heavy drinking days (Minimum = 0, Maximum = 30), assessed via the Time Line Follow Back, with greater scores meaning worse outcomes)
Sexual Victimization
Assessed via the Sexual Experiences Survey. Summary score calculated that reflects both frequency and severity (Minimum = 0, Maximum = 63). Higher scores mean worse outcomes.

Secondary Outcome Measures

Anxiety
Assessed via the Generalized Anxiety Disorder 7 (GAD-7) (Minimum = 0, Maximum = 21), with higher scores meaning worse outcomes.
Depression
Assessed via the Patient Health Questionnaire 9 (PHQ-9) (Minimum = 0, Maximum = 27), with higher scores meaning worse outcomes.
Mindfulness
Assessed via the Mindful Attention and Awareness Scale (Minimum = 15, Maximum = 90), with higher scores meaning better outcomes.

Full Information

First Posted
December 5, 2022
Last Updated
August 8, 2023
Sponsor
Lifespan
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1. Study Identification

Unique Protocol Identification Number
NCT05646446
Brief Title
Integrated Alcohol and Sexual Assault Prevention for Bisexual Women
Official Title
Integrated Alcohol and Sexual Assault Prevention for Bisexual Women
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
August 2025 (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 reducing alcohol use, sexual revictimization, and psychological distress among bisexual+ women (i.e., attraction to more than one gender: bisexual, pansexual, queer). The main questions the study seeks 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, relative to control, at the 2- and 4-month follow-up period, produce reductions in the quantity and frequency of alcohol use, sexual victimization, and psychological distress (anxiety, depression). Follow-up assessments are completed at 2- and 4-months following program completion. The intervention is compared to a wait list 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 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
REACH Program
Arm Type
Experimental
Arm Description
The REACH program addresses alcohol use, sexual assault risk, and experiences relating to experiences of harm among bisexual women.
Arm Title
Wait List Control Group
Arm Type
No Intervention
Arm Description
The Wait List Control Group will have the opportunity to complete the REACH program after completing study assessments at the 4-month follow-up.
Intervention Type
Behavioral
Intervention Name(s)
REACH Program
Intervention Description
The REACH program addresses alcohol use, sexual assault risk, and experiences relating to harm among bisexual women.
Primary Outcome Measure Information:
Title
Alcohol Use
Description
The number of past month drinking days (Minimum = 0, Maximum = 31), average drinks per drinking day (Minimum = 0, Maximum = unspecified), 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 4 months.
Title
Sexual Victimization
Description
Assessed via the Sexual Experiences Survey. Summary score calculated that reflects both frequency and severity (Minimum = 0, Maximum = 63). Higher scores mean worse outcomes.
Time Frame
Reductions in comparison to control at 4 months.
Secondary Outcome Measure Information:
Title
Anxiety
Description
Assessed via the Generalized Anxiety Disorder 7 (GAD-7) (Minimum = 0, Maximum = 21), with higher scores meaning worse outcomes.
Time Frame
Change from baseline at 4-months.
Title
Depression
Description
Assessed via the Patient Health Questionnaire 9 (PHQ-9) (Minimum = 0, Maximum = 27), with higher scores meaning worse outcomes.
Time Frame
Change from baseline at 4-months.
Title
Mindfulness
Description
Assessed via the Mindful Attention and Awareness Scale (Minimum = 15, Maximum = 90), with higher scores meaning better outcomes.
Time Frame
Change from baseline at 4-months.

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Female gender or fluid, gender non-conforming, gender queer, or non-binary
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 years of age; identify as female gender or fluid, or gender non-conforming, gender queer, or non-binary identify as bisexual+ (i.e., attraction to more than one gender: bisexual, pansexual, queer); report a history of attempted or completed penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via coercion, 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. Exclusion Criteria: current suicide risk on the Beck Depression Inventory current symptoms of alcohol use withdrawal on the Alcohol Use Withdrawal Checklist
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay Orchowski, PhD
Phone
4014447021
Ext
7021
Email
lindsay_orchowski@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
Per sponsor requirements, data will be shared using the National Institutes of Mental Health Data Archive.
IPD Sharing Time Frame
The research team will submit data on or before the Data Archive submission due dates (April 1 and October 1 each year) in accordance with the applicable Data Sharing Terms and Conditions of the award.

Learn more about this trial

Integrated Alcohol and Sexual Assault Prevention for Bisexual Women

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