Integrated Alcohol and Sexual Assault Prevention for Bisexual Women

NCT05646446 | Withdrawn DMC

• 1 other identifier: R34AA030035
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use, Unspecified; Sexual Assault

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Anxiety

  Change from baseline at 4-months.

• Depression

  Change from baseline at 4-months.

• Mindfulness

  Change from baseline at 4-months.

Study Arms (2)

REACH Program

EXPERIMENTAL

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

Behavioral: REACH Program

Wait List Control Group

NO INTERVENTION

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

Interventions

REACH Program BEHAVIORAL

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

REACH Program

Eligibility Criteria

• Age: 18 Years - 24 Years
• Gender Eligibility Details: Female gender or fluid, gender non-conforming, gender queer, or non-binary
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• current suicide risk on the Beck Depression Inventory
• current symptoms of alcohol use withdrawal on the Alcohol Use Withdrawal Checklist

Sponsors & Collaborators

• Lifespan: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02904, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Research)

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 12, 2022
• Study Start: August 3, 2023
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.

Locations

US (1)