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Personalized Integrated Prevention Program for Reducing Heavy Drinking and Sexual Assault on College Campuses (+Change Trial)

N/A

Waitlist Available

Led By Amanda Gilmore, PhD

Research Sponsored by Georgia State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18-25 years old

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-, 6-, 9-, and 12-months

Awards & highlights

+Change Trial Summary

This trialwill test the effectiveness of a prevention program to reduce heavy drinking and sexual assault on college campuses.

Who is the study for?

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.Check my eligibility

What is being tested?

+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.See study design

What are the potential side effects?

As this is not a drug or medical treatment trial but rather an educational and behavioral intervention, traditional physical side effects are not applicable. However, participants may experience emotional or psychological responses to discussions of sensitive topics like alcohol use and sexual assault.

+Change Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 25 years old.

+Change Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-, 6-, 9-, and 12-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-, 6-, 9-, and 12-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-, 6-, 9-, and 12-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Alcohol use

Changes in Bystander Intervention

Changes in Sexual Assault Perpetration

+1 more

+Change Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Positive Change (+Change) Plus BoosterExperimental Treatment1 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 Treatment1 Intervention

Group III: ControlPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positive Change (+Change)

2018

N/A

~170

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arizona State UniversityOTHER

283 Previous Clinical Trials

106,214 Total Patients Enrolled

1 Trials studying Sexual Assault

165 Patients Enrolled for Sexual Assault

Georgia State UniversityLead Sponsor

57 Previous Clinical Trials

22,129 Total Patients Enrolled

1 Trials studying Sexual Assault

165 Patients Enrolled for Sexual Assault

Amanda Gilmore, PhDPrincipal InvestigatorGeorgia State University

1 Previous Clinical Trials

27 Total Patients Enrolled

Media Library

Positive Change (+Change) Clinical Trial Eligibility Overview. Trial Name: NCT05281874 — N/A

Sexual Assault Research Study Groups: Control, Positive Change (+Change) Plus Booster, Positive Change (+Change)

Sexual Assault Clinical Trial 2023: Positive Change (+Change) Highlights & Side Effects. Trial Name: NCT05281874 — N/A

Positive Change (+Change) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05281874 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility requirements for enrolment in this research trial?

"This trial is interested in enrolling 3300 people who have experienced sexual assault and are between 18-25 years of age. For eligibility, they must be a current student at the university being studied, provide an active email address registered to that institution, and attest to having partaken in heavy episodic drinking within the past month on the screening questionnaire."

Answered by AI

Is participation in this medical study limited to persons under the age of seventy-five?

"The parameters of this clinical trial dictate that the lowest permissible age is 18 and the eldest eligible participant must be no older than 25."

Answered by AI

Is enrollment currently open for this research study?

"The clinicaltrials.gov registry reveals that this trial has stopped recruiting participants since October 19th 2022; however, it also states that there are 250 other trials currently searching for patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students

Amanda Gilmore 2022. "Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05281874.