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Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students

Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05281874
Acronym
+Change
Enrollment
1116
Registered
2022-03-16
Start date
2022-10-03
Completion date
2026-05-31
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Sexual Assault

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).

Interventions

This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. It targets alcohol, sexual assault victimization risk, sexual assault perpetration, and bystander intervention. It is tailored by gender and sexual orientation.

BEHAVIORALA healthy lifestyles attention control

A healthy lifestyles attention control will be used as the control condition. We will match the control and intervention conditions on content (text, pictures, number of pages); type (interactive vs. psychoeducation); and average completion time.

BEHAVIORALPositive Change (+Change) Plus Booster

Positive Change (+Change) Plus Booster

Sponsors

Georgia State University
Lead SponsorOTHER
Arizona State University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

Participants and principal investigator will be masked to intervention conditions.

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Alcohol use3-, 6-, 9-, and 12-monthsNumber of drinks will be assessed using the daily drinking questionnaire. Higher scores indicate higher alcohol use.
Changes in Sexual Assault Victimization3-, 6-, 9-, and 12-monthsSexual 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 Intervention3-, 6-, 9-, and 12-monthsBystander 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 Perpetration3-, 6-, 9-, and 12-monthsSexual 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAmanda Gilmore, PhD

Georgia State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026