uSafeUS+ App for Reducing Alcohol Consumption and Sexual Assault Risk

TB
NS
Overseen ByNichole Scaglione, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to test the feasibility and acceptability of an innovative mobile application (uSafeUS+) to reduce college student drinking and sexual assault (SA) risk in real time. Following an initial period of app development, this study will use a pilot 3-arm randomized controlled trial (N = 90; 30/arm) to examine the acceptability, feasibility, and initial evidence of efficacy of the novel, expanded uSafeUS+ app, relative to the existing SA-only focused uSafeUS app (already in use on 24 college campuses), and an assessment-only control condition.

Specifically, the investigators aim to answer the following research questions:

1. Do students like the app (overall and specific features)?

2. How frequently do students use the app within the 1-month exposure period?

3. What barriers and facilitators impact app use?

4. Is there evidence of increased use of protective behaviors on drinking days and over time?

5. Is there evidence of decreased drinking (amount, frequency) or SA risk on drinking days and over time?

Participants will complete:

* A baseline assessment

* A 1-month app exposure period with daily surveys about app use on the weekends

* Follow-up surveys at 1- and 2-months post-intervention.

Are You a Good Fit for This Trial?

Inclusion Criteria

Currently enrolled as a residential undergraduate student at a participating university
I am between 18 and 25 years old.
Intend to reside on or near (in the same town) campus over the two-month study period
See 3 more

Exclusion Criteria

Unable or unwilling to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete a baseline survey to determine eligibility and assess prior behaviors

1 week
1 visit (virtual)

App Exposure

Participants use the assigned app for a 1-month period with daily surveys on weekends

4 weeks
Daily virtual surveys

Follow-up

Participants complete follow-up surveys to assess app impact on drinking and SA risk

2 months
2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • uSafeUS+

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: uSafeUS+Experimental Treatment1 Intervention
Group II: uSafeUSActive Control1 Intervention
Group III: assessment only (control)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+

University of New Hampshire

Collaborator

Trials
16
Recruited
105,000+