Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students
+Change
1 other identifier
interventional
3,300
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2022
CompletedStudy Start
First participant enrolled
October 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
August 22, 2025
August 1, 2025
3.7 years
November 5, 2021
August 18, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Changes in Alcohol use
Number of drinks will be assessed using the daily drinking questionnaire. Higher scores indicate higher alcohol use.
3-, 6-, 9-, and 12-months
Changes in Sexual Assault Victimization
Sexual 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.
3-, 6-, 9-, and 12-months
Changes in Bystander Intervention
Bystander 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.
3-, 6-, 9-, and 12-months
Changes in Sexual Assault Perpetration
Sexual 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.
3-, 6-, 9-, and 12-months
Study Arms (3)
Control
PLACEBO COMPARATORA 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)
EXPERIMENTALThis 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.
Positive Change (+Change) Plus Booster
EXPERIMENTALThis 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.
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.
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
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Georgia State Universitylead
- Arizona State Universitycollaborator
Study Sites (1)
Georgia State University
Atlanta, Georgia, 30303, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amanda Gilmore, PhD
Georgia State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants and principal investigator will be masked to intervention conditions.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 5, 2021
First Posted
March 16, 2022
Study Start
October 3, 2022
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
August 22, 2025
Record last verified: 2025-08