Development of an Alcohol, Cannabis, and Sexual Assault Risk Reduction Program for High Risk College Women

Development of an Alcohol, Cannabis, and Sexual Assault Risk Reduction Program for High Risk College Women, Pilot RCT

The goal of this clinical trial is to assess the feasibility of the Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program with alcohol and cannabis content (EAAA+) in undergraduate college women between ages 18-24 years old who use alcohol and cannabis. The main objectives it aims to answer are:

• To determine the feasibility of a randomized controlled trial comparing EAAA+ to an assessment only control condition.
• To determine if EAAA+ will result in larger decreases in HED and cannabis use, more accurate perceptions of alcohol and cannabis norms, and greater increases in PBS at follow up.
• To determine if EAAA+ will result in (1) greater increases in SA risk perception and use of assertive SA resistance strategies and (2) decreased barriers to SA resistance while using alcohol and cannabis, and (3) greater reductions in incapacitated SA.

Researchers will compare participants who received EAAA+ to an assessment only condition to test the objectives stated above.

Participants will:

• Sign an informed consent form and complete a survey. Once the survey is completed, they will be randomly assigned to complete the sexual assault education program or not.
• Participants assigned to the sexual assault education program will complete two in-person sessions (about 7 hours each) or four in-person sessions (about 3.5 hours each) and will also complete an online module in between modules 2 and 3 as part of the education program and complete four short surveys.
• Complete 4 weeks of assessments and complete a follow-up survey at 1, 3, and 6 months after the initial session.

Study Overview

• Status: Not yet recruiting
• Conditions: Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program With Alcohol and Cannabis Content
• Intervention / Treatment: Behavioral: Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program; Behavioral: Assessment Only Control

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruschelle M Leone, PhD; Phone Number: 303-724-7052; Email: ruschelle.leone@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
      • Contact: Ruschelle M Leone, PhD; Phone Number: 303-724-7052; Email: ruschelle.leone@cuanschutz.edu
      • Principal Investigator: Ruschelle M Leone, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study determined at pre-screening
3. Between the ages of 18-24 years old determined at pre-screening
4. Identifies as a woman determined at pre-screening
5. Is currently enrolled as an undergraduate in Colorado with a valid student email address determined at pre-screening
6. Engaged in heavy episodic drinking (i.e., 4+ drinks within a two-hour period) at least once in the past month with an intention to drink in the future determined at pre-screening
7. Engaged in using cannabis at least once in the past month with an intention to use in the future determined at pre-screening
8. Is available to attend sessions on specific dates
9. Has a phone they can complete web-based surveys on determined at pre-screening

Exclusion Criteria:

1. There are no exclusion criteria aside from not meeting inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program	Behavioral: Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program; Participants will be randomized to EAAA+, a combined program for alcohol and cannabis prevention and sexual assault risk reduction.
Active Comparator: Assessment Only Control	Behavioral: Assessment Only Control; Participants will be randomized to an assessment only control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cannabis Use Frequency Measured at Follow-Ups	Cannabis use frequency will be reported using a self-report at 1-month and 3- and 6-month follow ups.	Up to 1-month, 3-months, and 6-months post intervention
Heavy Episodic Drinking Frequency Measured at Follow-Ups	Heavy episodic drinking (HED) frequency will be reported using a self-report at 1-month and 3- and 6-month follow ups.	Up to 1-month, 3-months, and 6-months post intervention
Attempted Sexual Assault Measured at Follow-Ups	Attempted sexual assault will be reported using a self-report at 1-month and 3- and 6-month follow ups.	Up to 1-month, 3-months, and 6-months post intervention
Completed Sexual Assault Measured at Follow-Ups	Completed sexual assault will be reported using a self-report at 1-month and 3- and 6-month follow ups.	Up to 1-month, 3-months, and 6-months post intervention

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 24-2079; K01AA028844 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be available in the NIAAA Data Archive.

Drug and device information, study documents

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