Integrated Alcohol and Sexual Assault Prevention for Bisexual Women

Sponsor
Lifespan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05646446
Collaborator
(none)
90
1
2
29
3.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: REACH Program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Integrated Alcohol and Sexual Assault Prevention for Bisexual Women
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Alcohol Use [Change from baseline alcohol use at 4 months.]

    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)

  2. Sexual Victimization [Reductions in comparison to control at 4 months.]

    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

  1. Anxiety [Change from baseline at 4-months.]

    Assessed via the Generalized Anxiety Disorder 7 (GAD-7) (Minimum = 0, Maximum = 21), with higher scores meaning worse outcomes.

  2. Depression [Change from baseline at 4-months.]

    Assessed via the Patient Health Questionnaire 9 (PHQ-9) (Minimum = 0, Maximum = 27), with higher scores meaning worse outcomes.

  3. Mindfulness [Change from baseline at 4-months.]

    Assessed via the Mindful Attention and Awareness Scale (Minimum = 15, Maximum = 90), with higher scores meaning better outcomes.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 24 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rhode Island Hospital Providence Rhode Island United States 02904

Sponsors and Collaborators

  • Lifespan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lindsay Orchowski Ph.D., Associate Professor (Research), Lifespan
ClinicalTrials.gov Identifier:
NCT05646446
Other Study ID Numbers:
  • R34AA030035
First Posted:
Dec 12, 2022
Last Update Posted:
Dec 13, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 13, 2022