Development of an Alcohol, Cannabis, and Sexual Assault Risk Reduction Program for High Risk College Women
21. juli 2026 opdateret af: University of Colorado, Denver
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
200
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ruschelle M Leone, PhD
- Telefonnummer: 303-724-7052
- E-mail: ruschelle.leone@cuanschutz.edu
Studiesteder
-
-
Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado Anschutz Medical Campus
-
Kontakt:
- Ruschelle M Leone, PhD
- Telefonnummer: 303-724-7052
- E-mail: ruschelle.leone@cuanschutz.edu
-
Ledende efterforsker:
- Ruschelle M Leone, PhD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Aktiv komparator: Assessment Only Control
|
Participants will be randomized to an assessment only control.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cannabis Use Frequency Measured at Follow-Ups
Tidsramme: Up to 1-month, 3-months, and 6-months post intervention
|
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
Tidsramme: Up to 1-month, 3-months, and 6-months post intervention
|
Heavy episodic drinking (HED) frequency will be reported using a self-report at 1-month and 3- and 6-month follow ups.
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Up to 1-month, 3-months, and 6-months post intervention
|
|
Attempted Sexual Assault Measured at Follow-Ups
Tidsramme: Up to 1-month, 3-months, and 6-months post intervention
|
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
Tidsramme: Up to 1-month, 3-months, and 6-months post intervention
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. februar 2027
Studieafslutning (Anslået)
1. februar 2027
Datoer for studieregistrering
Først indsendt
21. juli 2026
Først indsendt, der opfyldte QC-kriterier
21. juli 2026
Først opslået (Faktiske)
24. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 24-2079
- K01AA028844 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
IPD will be available in the NIAAA Data Archive.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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