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Not yet recruiting NCT07726004

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

No phase Interventional Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program With Alcohol and Cannabis Content

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program, Assessment Only Control.
Who it may be relevant to
Registry conditions: Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program With Alcohol and Cannabis Content. Basic parameters: 18 years — 24 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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.
  • Behavioral Assessment Only Control
    Participants will be randomized to an assessment only control.

Primary outcome measures

  • Cannabis Use Frequency Measured at Follow-Ups [Time frame: Up to 1-month, 3-months, and 6-months post intervention]
  • Heavy Episodic Drinking Frequency Measured at Follow-Ups [Time frame: Up to 1-month, 3-months, and 6-months post intervention]
  • Attempted Sexual Assault Measured at Follow-Ups [Time frame: Up to 1-month, 3-months, and 6-months post intervention]
  • Completed Sexual Assault Measured at Follow-Ups [Time frame: Up to 1-month, 3-months, and 6-months post intervention]

Eligibility criteria

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study determined at pre-screening
  • Between the ages of 18-24 years old determined at pre-screening
  • Identifies as a woman determined at pre-screening
  • Is currently enrolled as an undergraduate in Colorado with a valid student email address determined at pre-screening
  • 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
  • Engaged in using cannabis at least once in the past month with an intention to use in the future determined at pre-screening
  • Is available to attend sessions on specific dates
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Colorado Anschutz Medical Campus — Aurora

Identifiers

NCT: NCT07726004 · 24-2079 · K01AA028844

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗