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Recruiting NCT07557745

uSafeUS+ App Pilot Testing

No phase Interventional Alcohol Consumption Sexual Assault

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: uSafeUS+, uSafeUS.
Who it may be relevant to
Registry conditions: Alcohol Consumption, Sexual Assault. Basic parameters: 18 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Behavioral uSafeUS+
    uSafeUS app
  • Behavioral uSafeUS
    uSafeUS app

Primary outcome measures

  • 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)]
Secondary outcome measures (3)
  • Evaluation design acceptability [Time frame: 2-month follow up]
  • Sustained App Usage [Time frame: 2-month follow-up]
  • Sustained App Acceptability [Time frame: 2-month Follow up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 2 centers
  • University of Florida — Gainesville
  • University of New Hampshire — Durham

Identifiers

NCT: NCT07557745 · 202501604 · R34AA031379

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗