Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Georgia State University
Study ID
NCT05281874
Status
Enrolling By Invitation

Conditions

  • Alcohol Drinking
  • Sexual Assault

Eligibility Criteria

Sex
ALL
Age
18 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Positive Change (+Change) — BEHAVIORAL
    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.
  • A healthy lifestyles attention control — BEHAVIORAL
    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.
  • Positive Change (+Change) Plus Booster — BEHAVIORAL
    Positive Change (+Change) Plus Booster

Study Details

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).

Key Dates

Start date
Oct 3, 2022
Status verified
Aug 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
3,300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: 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.
  • Experimental: Positive Change (+Change)
    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.
  • Experimental: Positive Change (+Change) Plus Booster
    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. It is provided at baseline and a booster at 6 months.

Primary Outcome Measure

Changes in Alcohol use [ Time Frame: 3-, 6-, 9-, and 12-months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Georgia State UniversityAtlantaGeorgia30303-

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