uSafeUS+ App Pilot Testing

NCT07557745 | Not Yet Recruiting

• 2 other identifiers: 202501604R34AA031379
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

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

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (3)

• Evaluation design acceptability

  2-month follow up

• Sustained App Usage

  2-month follow-up

• Sustained App Acceptability

  2-month Follow up

Study Arms (3)

uSafeUS+

EXPERIMENTAL

uSafeUS app with alcohol content

Behavioral: uSafeUS+

uSafeUS

ACTIVE COMPARATOR

Current UsafeUS app (no alcohol content)

Behavioral: uSafeUS

assessment only (control)

NO INTERVENTION

Control

Interventions

uSafeUS BEHAVIORAL

uSafeUS app

uSafeUS

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Unable or unwilling to provide informed consent

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• University of New Hampshire: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Central Study Contacts

Nichole Scaglione, PhD

CONTACT

3522940548; nscaglione@ufl.edu

Taylor Boswell, PhD

CONTACT

t.gravesboswell@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 29, 2026
• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared via the NIAAA data archive starting 10/1/2026 for as long as NIH keeps the archive active.
• Access Criteria: Per the signed DSA, data and supporting will be available upon reasonable request via the NIAAA data archive.

Locations

US (1)