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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Positive Change (+Change) to help reduce heavy drinking and sexual assault on college campuses. It compares two groups: one receiving +Change and another receiving +Change with a follow-up session six months later. The trial focuses on reducing alcohol use, decreasing sexual assault incidents, and enhancing bystander intervention (encouraging others to step in to prevent harm). College students who have engaged in heavy drinking at least once in the past month might be suitable for this trial. As an unphased study, this trial offers a unique opportunity to contribute to important research that could lead to safer college environments.

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 prior data suggests that this program is safe for college students?

Research shows that the Positive Change (+Change) program is easy to use and suitable for participants, including those of different gender identities and sexual orientations. It helps college students manage alcohol misuse and prevent sexual assault.

In earlier studies, participants found the program simple to use and understand, with no major safety issues reported. This indicates the program is generally well-received.

The version with a booster session, called Positive Change (+Change) Plus Booster, is also considered safe. This version provides extra support six months later to help maintain the program's benefits.

Both versions aim to reduce heavy drinking and improve how students respond to sexual assault. They are customized to fit the needs of different students. Overall, research suggests these programs are safe and easy to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Positive Change (+Change) interventions because they offer a fresh approach to tackling heavy drinking and sexual assault on college campuses. Unlike traditional methods that might focus solely on education or punishment, these interventions use personalized feedback and social norms to address not just alcohol misuse but also the risks of sexual assault and bystander intervention. The interventions are tailored specifically by gender and sexual orientation, which could make them more effective and relevant for diverse student populations. The addition of a booster session at six months for the +Change Plus Booster arm aims to reinforce and sustain positive behavior changes over time.

What evidence suggests that this trial's treatments could be effective for reducing heavy drinking and sexual assault on college campuses?

Research shows that the Positive Change (+Change) program, one of the interventions in this trial, promises to reduce heavy drinking and address sexual assault issues among college students. An initial study found that +Change effectively reduced alcohol misuse and the risk of sexual assault for both victims and perpetrators. Studies also indicate that the program improves bystander intervention, encouraging students to step in and help prevent assaults. Another intervention in this trial, the +Change Plus Booster, includes a follow-up session after six months and offers similar benefits, helping maintain long-term reductions in risky behaviors. Overall, early findings suggest these programs are practical strategies for creating safer college environments. ^{6 7 8 9 10}

Who Is on the Research Team?

Amanda Gilmore, PhD

Principal Investigator

Georgia State University

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871625003072

Reduced drinking as a mechanism for alcohol and ... Positive Change© was designed specifically for heavy drinking college students. The first version adapted the highly Web-BASICS (Larimer et al., 2023) into ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05281874

Personalized Integrated Alcohol and Sexual Assault ... This study includes a randomized controlled trial of Positive Change (+Change), an integrated alcohol and sexual assault prevention program, compared to an ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39329408/

A Pilot Randomized Controlled Trial of an Integrated ... The current study presents preliminary efficacy findings of a pilot randomized controlled trial of Positive Change © (+Change © ).

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/08862605241275994?int.sj-full-text.similar-articles.9

A Pilot Randomized Controlled Trial of an Integrated ... No adverse effects among those receiving the intervention were observed. Findings suggested that +Change© may be a feasible strategy to prevent ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37995129/

Integrated Alcohol Use and Sexual Assault Prevention ... Results regarding bystander intervention intentions were mixed, with the MBCC group showing decreased intentions at 2 months and the SAFE group ...

6. formative.jmir.org formative.jmir.org/2022/7/e23823

Web-Based Alcohol and Sexual Assault Prevention Program ... Results: Our findings indicated that +Change was acceptable and usable among all participants, despite gender identity or sexual orientation.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9356330/

Web-Based Alcohol and Sexual Assault Prevention ... This study assessed the usability and acceptability of +Change, a multipronged program targeting alcohol misuse, sexual assault victimization ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10704318/

Integrated Alcohol Use and Sexual Assault Prevention ... This study aims to examine the initial feasibility-, acceptability-, and efficacy-related outcomes of a randomized pilot trial of an integrated alcohol and ...

9. researchgate.net researchgate.net/publication/384408204_Preliminary_Efficacy_of_Positive_ChangeChange_A_Pilot_Randomized_Controlled_Trial_of_an_Integrated_Alcohol_and_Sexual_Assault_Prevention_Program_Tailored_by_Gender_and_Sexual_Orientation

A Pilot Randomized Controlled Trial of an Integrated ... The current study presents preliminary efficacy findings of a pilot randomized controlled trial of Positive Change© (+Change© ).

10. clinicaltrials.gov clinicaltrials.gov/study/NCT05257603?term=AREA%5BConditionSearch%5D(%22Alcohol%20Drinking%20in%20College%22)&rank=9

Prevention of Alcohol-related Sexual Revictimization in ... The investigators hypothesize that women in RPCW intervention will report fewer days of hazardous drinking and improved perception of sexual assault risk cues ...