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Clinical Trial 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).


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05281874
Study type Interventional
Source Georgia State University
Contact
Status Enrolling by invitation
Phase N/A
Start date October 3, 2022
Completion date May 31, 2026

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