uSafeUS+ App Pilot Testing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorUniversity of Florida
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
Unable or unwilling to provide informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
uSafeUS+
BehavioraluSafeUS app
uSafeUS
BehavioraluSafeUS app
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: uSafeUS+Experimental treatment 1 intervention
Group B: uSafeUSActive comparator 1 intervention
Group C: assessment only (control)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Enrollment Rate
The proportion of eligible participants (based on screening completion) who formally enroll in the study and complete baseline procedures.
Time frame
Baseline2
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.
Time frame
1-month follow-up3
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.
Time frame
2-month follow up4
Daily Protocol Compliance
For all groups, the investigators will calculate the percentage of daily surveys that each participant completes.
Time frame
1-month (assessed via daily surveys)Secondary outcomes
1
Evaluation design acceptability
Proportion of participants reporting willingness to participate in a study like this again
Time frame
2-month follow up2
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).
Time frame
2-month follow-up3
Sustained App Acceptability
Proportion of participants who indicate they would recommend the app to a friend one month after initial exposure.
Time frame
2-month Follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
University of New Hampshire
Collaborator
Source ClinicalTrials.gov