uSafeUS+ App Pilot Testing

Expanding the uSafeUS Mobile App to Reduce Alcohol-Involved Sexual Assault on College Campuses

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alcohol Consumption; Sexual Assault
• Intervention / Treatment: Behavioral: uSafeUS+; Behavioral: uSafeUS

Detailed Description

Over 75% of campus sexual assaults involve alcohol, yet existing campus alcohol and SA prevention efforts designed for universal delivery are often siloed and limited in their ability to provide students with in-the-moment assistance to reduce risk. Smartphone apps are an integral part of college student life and are increasingly used to engage students in real-time alcohol prevention; however, none have integrated alcohol and sexual assault prevention into a single cross-cutting tool. This study addresses this gap by expanding a promising campus sexual assault prevention and response app (uSafeUS®) to include evidence-based alcohol harm reduction tools and real-time messaging to support students' use of protective behavioral strategies (PBS) in the moments when they most need them. The uSafeUS app, currently in use on 24 US college campuses, utilizes sexual assault PBS (e.g., sharing current locations and an expected return home time with trusted peers) as the primary risk reduction mechanism for students to use in social contexts where alcohol is present, yet none of the existing features directly address alcohol consumption. This project will leverage the existing uSafeUS infrastructure and a proven user-centered development process to expand app features to include an interactive drink tracker and personalized feedback messaging to reduce alcohol consumption and increase PBS use (uSafeUS+).

Following app development, the investigators will conduct a 3-arm pilot randomized controlled trial (N = 90) using an intensive longitudinal design to test uSafeUS+, relative to active (uSafeUS) and assessment-only control groups. Long term, uSafeUS+ is expected to reduce drinking outcomes and SA risk at 3-month follow-up by increasing PBS use and decreasing the amount students drink on days when students use PBS app features. This study will establish the feasibility and acceptability of uSafeUS+ and our proposed event-level evaluation approach, which is innovative and necessary to examine both between-group differences in behavioral outcomes over time and within-person variability in app feature use, acceptability, and behavioral outcomes across app use days, relative to non-app use days.

Specifically, the investigators will examine: a) app evaluability and evaluation plan feasibility using enrollment, retention, compliance, and app use data; b) overall acceptability of the app and evaluation procedures, including event-level variability in app acceptability during a 1-month app exposure period; c) psychometric properties of evaluation instruments; and d) preliminary effect sizes of app impacts on drinking and PBS use at the event level (via weekend daily diaries; uSafeUS+ vs. uSafeUS), and SA risk outcomes over time (1- and 2-month follow up; uSafeUS+ vs. uSafeUS + assessment-only control).

Participants will complete a baseline survey, which will determine participant eligibility, randomly assign students to conditions, and assess prior drinking behaviors, protective behavior use, and sexual assault experiences. Students in the uSafeUS+ or uSafeUS groups will be trained in using their assigned app and the daily survey protocols, followed by a 1-month app exposure period with integrated weekend daily diary assessments of event-level app feature acceptability, use context (where they were, who they were with), and outcomes (e.g., daily drinking, protective behavior use). The investigators will also passively collect embedded metadata on daily app usage. All students, regardless of group assignment, will complete 1- and 2-month drinking and SA risk surveys.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nichole Scaglione, PhD; Phone Number: 3522940548; Email: nscaglione@ufl.edu
• Study Contact Backup: Name: Taylor Boswell, PhD; Email: T.gravesboswell@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
      • Contact: Taylor Boswell, PhD; Email: T.gravesboswell@ufl.edu
      • Contact: Nichole Scaglione, PhD; Phone Number: 352-294-0548; Email: nscaglione@ufl.edu
      • Principal Investigator: Nichole Scaglione, PhD
  • New Hampshire
    • Durham, New Hampshire, United States, 03824
      • University of New Hampshire
      • Contact: Sharyn Potter, PhD; Phone Number: 603-862-3630; Email: sharyn.potter@unh.edu
      • Principal Investigator: Sharyn Potter, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: uSafeUS+; uSafeUS app with alcohol content	Behavioral: uSafeUS+; uSafeUS app; Other Names: uSafeUS
Active Comparator: uSafeUS; Current UsafeUS app (no alcohol content)	Behavioral: uSafeUS; uSafeUS app
No Intervention: assessment only (control); Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment Rate	The proportion of eligible participants (based on screening completion) who formally enroll in the study and complete baseline procedures.	Baseline
Retention from enrollment to 1-month follow up.	Retention from enrollment to 1-month follow-up will be defined as the proportion of enrolled participants who complete the 1-month follow-up assessment.	1-month follow-up
Retention from enrollment to 2-month follow up.	Retention from enrollment to 2-month follow-up will be defined as the proportion of enrolled participants who complete the 2-month follow-up assessment.	2-month follow up
Daily Protocol Compliance	For all groups, the investigators will calculate the percentage of daily surveys that each participant completes.	1-month (assessed via daily surveys)
App use protocol compliance	The investigators will record the percentage of participants in uSafeUS+® and uSafeUS® groups who use the app at least weekly (minimum compliance)	1-month (assessed via daily surveys)
Overall App Usage	Number of days students use the app during the 1-month exposure period; this will be captured in the daily diaries for the uSafeUS+ and uSafeUS app groups.	1-month (assessed via daily surveys)
Overall App Acceptability	Overall app feature acceptability will be assessed at the end of the exposure period using the System Usability Scale (SUS). At 1 month Follow-up, the investigators will assess acceptability via SUS total score.	1-month Follow Up (immediately post-intervention exposure)
Event- Level App Feature Acceptability	Within the daily surveys, feature acceptability assessments are adapted from standard app usability measures, such as the System Usability Scale (SUS; Brooke, 1996; Lewis, 2018) to assess the extent to which students found the features was easy to use. The investigators will report the aggregate mean (SD) across the features and app use period.	1-month (assessed via daily surveys)
Event- Level App Messaging Acceptability	Adapted from measures used in Dr. Suffoletto's text-based intervention work and Dr. Scaglione's tailored app-based intervention development, the investigators will assess whether the real-time and engagement message content felt personally relevant. Daily diary measures will adapt these items to ask specifically about any messages they received the day before. The investigators will report an aggregate mean (SD) across the app use period for the uSafeUS+ group.	1-month (assessed via daily surveys)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation design acceptability	Proportion of participants reporting willingness to participate in a study like this again	2-month follow up
Sustained App Usage	Proportion of uSafeUS+ and uSafeUS participants who endorse continued use of their assigned app in the month after the exposure period (report separately by condition).	2-month follow-up
Sustained App Acceptability	Proportion of participants who indicate they would recommend the app to a friend one month after initial exposure.	2-month Follow up

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); University of New Hampshire

Study record dates

Study Major Dates

• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: College students; MHealth; Alcohol harm reduction; Sexual Assault Risk Reduction; Protective Behavioral Strategy Use
• Additional Relevant MeSH Terms: Drinking Behavior; Behavior; Alcohol Drinking
• Other Study ID Numbers: 202501604; R34AA031379 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data from the baseline, daily diary, and follow-up assessments will be shared per NIH requirements established through the negotiated data sharing agreement.
• IPD Sharing Time Frame: Data will be shared via the NIAAA data archive starting 10/1/2026 for as long as NIH keeps the archive active.
• IPD Sharing Access Criteria: Per the signed DSA, data and supporting will be available upon reasonable request via the NIAAA data archive.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No