Integrated Alcohol and Sexual Assault Prevention for Bisexual Women

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use, Unspecified; Sexual Assault
• Intervention / Treatment: Behavioral: REACH Program

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lindsay Orchowski, PhD; Phone Number: 7021 4014447021; Email: lindsay_orchowski@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Recruiting
      • Rhode Island Hospital
      • Contact: Lindsay M Orchowski, Ph.D.; Phone Number: 401-444-7021; Email: Lindsay_Orchowski@brown.edu
      • Principal Investigator: Lindsay M Orchowski, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REACH Program; The REACH program addresses alcohol use, sexual assault risk, and experiences relating to experiences of harm among bisexual women.	Behavioral: REACH Program; The REACH program addresses alcohol use, sexual assault risk, and experiences relating to harm among bisexual women.
No Intervention: Wait List Control Group; The Wait List Control Group will have the opportunity to complete the REACH program after completing study assessments at the 4-month follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Change from baseline alcohol use at 4 months.
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.	Reductions in comparison to control at 4 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Assessed via the Generalized Anxiety Disorder 7 (GAD-7) (Minimum = 0, Maximum = 21), with higher scores meaning worse outcomes.	Change from baseline at 4-months.
Depression	Assessed via the Patient Health Questionnaire 9 (PHQ-9) (Minimum = 0, Maximum = 27), with higher scores meaning worse outcomes.	Change from baseline at 4-months.
Mindfulness	Assessed via the Mindful Attention and Awareness Scale (Minimum = 15, Maximum = 90), with higher scores meaning better outcomes.	Change from baseline at 4-months.

Collaborators and Investigators

• Sponsor: Lifespan

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: R34AA030035 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No