Personalized Integrated Alcohol & Sexual Assault Prevention Among College

Status Enrolling by invitation

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

Clinical Trial Details

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

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05414344` - A Brief Intervention for Alcohol Users With Interpersonal Trauma	N/A
Completed	`NCT05521906` - Evaluation of PRYSHM for LGBTQIA2S+ Youth	N/A
Not yet recruiting	`NCT04786587` - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Withdrawn	`NCT04659278` - Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use	N/A
Not yet recruiting	`NCT03632408` - Hangover and Residual Zopiclone Effect on Spatial Perception	Phase 1
Completed	`NCT02718508` - An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use	N/A
Active, not recruiting	`NCT02629679` - Sports, Education and Consumption of Substances in Adolescents	N/A
Completed	`NCT02945371` - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life	N/A
Completed	`NCT01553136` - Varenicline Treatment of Alcohol Dependence in Smokers	Phase 2
Completed	`NCT01442753` - Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth	N/A
Completed	`NCT01081119` - Brief Voluntary Alcohol and Drug Intervention for Middle School Youth	Phase 2
Completed	`NCT04510116` - Adults In The Making Prevention Trial	N/A
Completed	`NCT00289965` - Substance Use Risk Education (SURE) Project	Phase 2
Completed	`NCT00506753` - Motivation and Skills for Delta-9-tetrahydrocannabinol/Ethanol (THC/ETOH+) Teens in Jail	N/A
Recruiting	`NCT05288790` - Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT	Phase 2
Recruiting	`NCT05620849` - Young Adult Education on Alcohol & Health	N/A
Recruiting	`NCT03588754` - Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking?	Phase 2
Recruiting	`NCT04054466` - Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients in HAART	N/A
Recruiting	`NCT06074341` - TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study	N/A
Terminated	`NCT04596267` - Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students — +Change

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms