Personalized Integrated Prevention Program for Reducing Heavy Drinking and Sexual Assault on College Campuses

(+Change Trial)

Overseen By Amanda Gilmore, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Georgia State University

Disqualifiers: Not a student, Under 18, others

Compensation: Varies

Number of Visits: 5

3300 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on alcohol use and sexual assault prevention, so it's best to check with the trial organizers for specific guidance.

What data supports the effectiveness of this treatment for reducing heavy drinking and sexual assault on college campuses?

Research shows that web-based programs targeting both alcohol use and sexual assault risk can effectively reduce heavy drinking and sexual assault incidents among college students, especially those with a history of such experiences. Additionally, peer-led bystander training programs have been effective in reducing high-risk drinking and increasing awareness and intervention in sexual misconduct situations. ^{1 2 3 4 5}

Is the Personalized Integrated Prevention Program for Reducing Heavy Drinking and Sexual Assault on College Campuses safe for participants?

The studies reviewed focus on interventions for reducing alcohol use and risky behaviors among college students, but they do not report any specific safety concerns related to these interventions. Generally, these types of programs are designed to be safe and supportive for participants. ^{6 7 8 9 10}

What makes the Positive Change (+Change) treatment unique for reducing heavy drinking and sexual assault on college campuses?

The Positive Change (+Change) treatment is unique because it integrates personalized feedback interventions (PFIs) and behavior change theories to specifically target heavy drinking and sexual assault among college students, offering a tailored approach that combines individual and community-level strategies. ^{8 10 11 12 13}

Research Team

Amanda Gilmore, PhD

Principal Investigator

Georgia State University

Eligibility Criteria

This trial is for college students aged 18-25 who engage in heavy episodic drinking at least once a month and are currently enrolled at the university conducting the study. They must have a valid university email address. There are no other specific exclusion criteria.

Inclusion Criteria

I am between 18 and 25 years old.

Current student at university of study

Valid email address at university of study

Exclusion Criteria

There are no exclusion criteria other than not meeting inclusion criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Intervention

Participants receive the Positive Change (+Change) intervention targeting alcohol misuse and sexual assault

1 session

1 visit (in-person or virtual)

Booster Session

Participants in the +Change plus Booster group receive an additional session to reinforce the intervention

1 session at 6 months

1 visit (in-person or virtual)

Follow-up

Participants are monitored for changes in alcohol use, sexual assault victimization and perpetration, and bystander intervention

12 months

Assessments at 3, 6, 9, and 12 months

Treatment Details

Interventions

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

Trial Overview +Change, an alcohol and sexual assault prevention program, is being tested against a control condition to see if it reduces alcohol use and sexual assault while increasing bystander intervention. The trial also examines whether adding a Booster session after 6 months enhances long-term benefits.

Participant Groups

Group I: Positive Change (+Change) Plus Booster Experimental Treatment 1 Intervention

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.

Group II: Positive Change (+Change) Experimental Treatment 1 Intervention

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.

Group III: Control Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials

71

Recruited

33,600+

Arizona State University

Collaborator

Trials

311

Recruited

109,000+

Findings from Research

Personalized drinking feedback interventions (PFIs) are effective in reducing harmful alcohol misuse among college students, based on a comprehensive review of 41 studies.

Interventions that included components like decisional balance, practical costs, and risk-limiting strategies showed significantly larger effects, highlighting the importance of these elements in developing effective feedback-based interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized feedback interventions for college alcohol misuse: an update of Walters & Neighbors (2005). Miller, MB., Leffingwell, T., Claborn, K., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Personalized normative feedback for hazardous drinking among college women: Differential outcomes by history of incapacitated rape. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Preventing and Responding to Sexual Misconduct: Preliminary Efficacy of a Peer-Led Bystander Training Program for Preventing Sexual Misconduct and Reducing Heavy Drinking Among Collegiate Athletes. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Bridging the gap between genetic epidemiological research and prevention: A randomized control trial of a novel personalized feedback program for alcohol and cannabis use. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of interventions targeting alcohol, drug and smoking behaviors in university and college students: A review of randomized controlled trials. [2020]

5. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial targeting alcohol use and sexual assault risk among college women at high risk for victimization. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Integrated Alcohol Use and Sexual Assault Prevention Program for College Men Who Engage in Heavy Drinking: Randomized Pilot Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Web-based intervention to change perceived norms of college student alcohol use and sexual behavior on spring break. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Individual-focused approaches to the prevention of college student drinking. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Personalized normative feedback interventions targeting hazardous alcohol use and alcohol-related risky sexual behavior in Swedish university students: A randomized controlled replication trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

A sequential multiple assignment randomized trial (SMART) protocol for empirically developing an adaptive preventive intervention for college student drinking reduction. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Integrating Self-Affirmation and Implementation Intentions: Effects on College Student Drinking. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Environmental approaches to prevention in college settings. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Personalized feedback interventions for college alcohol misuse: an update of Walters & Neighbors (2005). [2022]