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Clinical Trials/NCT05281874
NCT05281874
Enrolling By Invitation
Not Applicable

Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students

Georgia State University1 site in 1 country3,300 target enrollmentOctober 3, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Drinking
Sponsor
Georgia State University
Enrollment
3300
Locations
1
Primary Endpoint
Changes in Alcohol use
Status
Enrolling By Invitation
Last Updated
8 months ago

Overview

Brief Summary

Heavy episodic drinking and sexual assault are problematic on college campuses. This study includes a randomized controlled trial of Positive Change (+Change), an integrated alcohol and sexual assault prevention program, compared to an attention-matched control condition across two universities in reducing alcohol use, sexual assault victimization, sexual assault perpetration, and increasing sexual assault bystander intervention. This study will also test the efficacy of +Change plus Booster session, an identical version of +Change delivered 6 months after the baseline, compared to +Change alone in long-term reductions in alcohol use, sexual assault victimization, sexual assault perpetration, and increases in sexual assault bystander intervention. This research is the next step of a NIAAA-funded planning grant (R34AA025691).

Detailed Description

Aim 1: Test the efficacy of Positive Change (+Change) among college students in each risk group (cisgender heterosexual men; cisgender heterosexual women; LGBTQ). Students aged 18-25 who engage in heavy episodic drinking will be recruited from 2 large public universities (n = 3,300) and will be randomly assigned to +Change, +Change plus +Booster, or an attention control. Alcohol use, sexual assault (victimization and perpetration), and bystander intervention will be assessed at baseline, 3-, 6-, 9-, and 12-month follow-ups. H1a: +Change conditions (+Change and +Change plus Booster) will result in less alcohol use, less sexual assault (victimization and perpetration), and more bystander intervention compared to the control condition at 3-month follow-up and maintained at 6 months. H1b: +Change plus booster at 6-months will maintain less alcohol use, less sexual assault (victimization and perpetration), and more bystander intervention compared to +Change over 9- and 12-month follow-ups (i.e., less decay of change). Aim 2: Investigate theoretical mechanisms through which +Change conditions impact alcohol use (e.g., descriptive drinking norms, drinking to cope with minority stress for LGBTQ students), sexual assault victimization and perpetration (e.g., sexual assault-related norms, sexual assault resistance self-efficacy, hypergender ideology), and bystander intervention (e.g., bystander intervention self-efficacy). Exploratory Aim: Examine +Change efficacy among LGBTQ subgroups (lesbian, gay, bisexual, trans, non-binary gender, gender queer, queer/questioning, intersex, asexual).

Registry
clinicaltrials.gov
Start Date
October 3, 2022
End Date
May 31, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amanda Gilmore

Assistant Professor

Georgia State University

Eligibility Criteria

Inclusion Criteria

  • 18-25 years old
  • Current student at university of study
  • Valid email address at university of study
  • Endorse engaging in heavy episodic drinking at least once in the past month on the screening survey

Exclusion Criteria

  • There are no exclusion criteria other than not meeting inclusion criteria

Outcomes

Primary Outcomes

Changes in Alcohol use

Time Frame: 3-, 6-, 9-, and 12-months

Number of drinks will be assessed using the daily drinking questionnaire. Higher scores indicate higher alcohol use.

Changes in Sexual Assault Victimization

Time Frame: 3-, 6-, 9-, and 12-months

Sexual assault victimization severity will be assessed using a modified version of the Sexual Experiences Survey. Responses are rated on number of times each experience occurred (0, 1, 2, 3+). Higher scores indicate higher sexual assault victimization.

Changes in Bystander Intervention

Time Frame: 3-, 6-, 9-, and 12-months

Bystander intervention behavior will be assessed using the 44-item Bystander Behavior Scale to assess engaging in bystander behavior with friends. Responses indicate if the participant engaged in each bystander behavior with a friend or not, or if they had no opportunity to engage in the behavior. Higher scores indicate higher bystander intervention behaviors.

Changes in Sexual Assault Perpetration

Time Frame: 3-, 6-, 9-, and 12-months

Sexual assault perpetration severity will be assessed using a modified version of the Sexual Strategies Survey. Participants check all items that apply. Higher scores indicate higher sexual assault perpetration.

Study Sites (1)

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