Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02777086 |
| Other study ID # |
DA25885-1506-060-1508 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 30, 2015 |
| Est. completion date |
March 31, 2020 |
Study information
| Verified date |
October 2020 |
| Source |
Texas Christian University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of the Texas Christian University (TCU) Disease Risk Reduction (DRR2) Project is
to develop and test a self-administered tablet computer app, StaySafe, for probationers under
community supervision that is designed to improve decision-making skills around health risk
behaviors, especially involving HIV and hepatitis B & C risks. StaySafe utilizes materials
and concepts adapted from an earlier, group-based curriculum, WaySafe, designed to increase
positive decision-making skills for offenders in the last phase of their prison-based
substance abuse treatment before transitioning back to the community.
Description:
The purpose of the TCU DRR2 project is to adapt ideas and concepts from an in-prison,
group-based curriculum designed to improved decision-making skills around health risk
behaviors for incarcerated offenders in the last phase of substance abuse treatment for a
self-administered computer app that targets probationers under community supervision.
Programming for HIV in probation settings is limited and this project aims to address needs
with an easy to use computer app that is designed to improve decision-making about health
risks among probationers in the community. The computer app utilizes an evidence-based schema
called WORKIT and is based on a dual processing model of judgment and decision-making that
includes vicarious and virtual learning approaches and repetition in order to learn and
practice the schema and move it from slower analytical processing to faster experiential
processing.
StaySafe includes 12 brief sessions, each of which takes about 10 minutes to complete. Nine
of the sessions utilize the WORKIT model and three session use a participant choice activity
in which probationers can choose from among several informational activities designed to
reinforce lessons learned and provide some variation to completing WORKIT sessions. The first
session includes an introduction to using the app on the tablet and guides the participant
through a WORKIT session. In each subsequent WORKIT session, the participant chooses a
relevant problem to work on during that session from a list of problems. A brief video is
then shown in which two people are having a conversation around the problem and make a
decision. The participant rates the decision before working through the WORKIT process around
the chosen problem. This involves determining what the problem is, who is affected by the
problem and who can help with the problem, then identifying options to address the problem,
rating the options, knowing what option to choose, imagining the steps to carry out the
option, and then testing the results. Sessions are typically scheduled about every two weeks.
Participants are recruited by research staff for the study from probation offices where
substance abuse groups are conducted. All assessment and StaySafe sessions are administered
by research staff at the probation facility when probationers otherwise report for meetings
or groups. Compensation for time involved in the study is provided in terms of payments
toward probation fees. After an Institutional Review Board (IRB)-approved consent procedure,
participants are scheduled for a baseline survey that takes about 30 minutes to complete.
After the baseline survey is completed, participants are randomly assigned to either the
StaySafe condition or a comparison condition. Participants in the StaySafe condition are then
scheduled for their first StaySafe session typically within a week and are asked to complete
twelve sessions within the next 6 months, followed by 6-month and 12-month follow-up surveys.
Participants randomly assigned to a comparison condition are informed that they will be
contacted in about 6 months to schedule a 6-month survey and again for a 12-month survey.
