Recruiting

uSafeUS+

Sponsor:

University of Florida

Code:

NCT07557745

Conditions

Alcohol Consumption

Sexual Assault

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

Interventions

uSafeUS+

uSafeUS

Study Details

Brief summary:

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.

Conditions

Alcohol Consumption

Sexual Assault

Study ID

NCT07557745

Start date

May 11, 2026

Status verified date

May, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participants must be between the ages of 18 and 25 years old;
  • Currently enrolled as a residential undergraduate student at a participating university;
  • Intend to reside on or near (in the same town) campus over the two-month study period
  • Own a smartphone/mobile device;
  • Have consumed at least one alcoholic beverage per week or engaged in dating or social behaviors where alcohol is present at least once a week over the past 30 days;
  • Intend to drink or go out at the same frequency (at least weekly) over the two-month study period

Exclusion Criteria:

  • Unable or unwilling to provide informed consent

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: uSafeUS+

uSafeUS app with alcohol content

active comparator: uSafeUS

Current UsafeUS app (no alcohol content)

no intervention: assessment only (control)

Control

Interventions

uSafeUS+

uSafeUS app

uSafeUS

uSafeUS app

Primary outcome measure

  • Enrollment Rate [ Time Frame: Baseline ]
  • Retention from enrollment to 1-month follow up. [ Time Frame: 1-month follow-up ]
  • Retention from enrollment to 2-month follow up. [ Time Frame: 2-month follow up ]
  • Daily Protocol Compliance [ Time Frame: 1-month (assessed via daily surveys) ]
  • App use protocol compliance [ Time Frame: 1-month (assessed via daily surveys) ]
  • Overall App Usage [ Time Frame: 1-month (assessed via daily surveys) ]
  • Overall App Acceptability [ Time Frame: 1-month Follow Up (immediately post-intervention exposure) ]
  • Event- Level App Feature Acceptability [ Time Frame: 1-month (assessed via daily surveys) ]
  • Event- Level App Messaging Acceptability [ Time Frame: 1-month (assessed via daily surveys) ]

Central Contacts and Locations

Central contacts

Nichole Scaglione, PhD

3522940548nscaglione@ufl.edu

Taylor Boswell, PhD

t.gravesboswell@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Nichole Scaglione, PhD

352-294-0548nscaglione@ufl.edu

Taylor Boswell, PhD

T.gravesboswell@ufl.edu

Principal Investigator:

Nichole Scaglione, PhD

More Information

Sponsor

University of Florida

Last update posted

Jun 15, 2026

Last verified

May, 2026

Keywords

  • Alcohol harm reduction
  • Sexual Assault Risk Reduction
  • Protective Behavioral Strategy Use
  • College students
  • MHealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-06-15.