Clinical trial NCT05281874: Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students
Official title: Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Alcohol Drinking
Sexual Assault
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: Arizona State University
First posted: 2022-03-16
Enrollment: 3300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Changes in Alcohol use
timeFrame: 3-, 6-, 9-, and 12-months
measure: Changes in Sexual Assault Victimization
timeFrame: 3-, 6-, 9-, and 12-months
measure: Changes in Bystander Intervention
timeFrame: 3-, 6-, 9-, and 12-months
measure: Changes in Sexual Assault Perpetration
timeFrame: 3-, 6-, 9-, and 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
affiliation: Georgia State University
name: Amanda Gilmore, PhD
role: PRINCIPAL_INVESTIGATOR
References: