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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07726004
Enrollment
200
Registered
2026-07-24
Start date
2026-08-01
Completion date
2027-02-01
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program With Alcohol and Cannabis Content

Brief summary

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.

Interventions

BEHAVIORALEnhanced 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.

Participants will be randomized to an assessment only control.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 24 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cannabis Use Frequency Measured at Follow-UpsUp to 1-month, 3-months, and 6-months post interventionCannabis use frequency will be reported using a self-report at 1-month and 3- and 6-month follow ups.
Heavy Episodic Drinking Frequency Measured at Follow-UpsUp to 1-month, 3-months, and 6-months post interventionHeavy episodic drinking (HED) frequency will be reported using a self-report at 1-month and 3- and 6-month follow ups.
Attempted Sexual Assault Measured at Follow-UpsUp to 1-month, 3-months, and 6-months post interventionAttempted sexual assault will be reported using a self-report at 1-month and 3- and 6-month follow ups.
Completed Sexual Assault Measured at Follow-UpsUp to 1-month, 3-months, and 6-months post interventionCompleted sexual assault will be reported using a self-report at 1-month and 3- and 6-month follow ups.

Countries

United States

Contacts

CONTACTRuschelle M Leone, PhD
ruschelle.leone@cuanschutz.edu303-724-7052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026