Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04574193 |
Other study ID # |
2R44MD008848-02 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 8, 2021 |
Est. completion date |
February 28, 2023 |
Study information
Verified date |
October 2023 |
Source |
COG Analytics |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This project extends successful Phase I work that developed a Continuing Care mobile
application (app) for probationers and parolees with SUDs who are at elevated risk of
relapse, re-arrest, and incarceration. This Phase II STTR project will finalize app
development and evaluate its efficacy in a randomized controlled trial. The project has high
public health significance due to its potential to provide an accessible recovery support
tool for individuals on probation or parole that could improve their substance use disorder
treatment outcomes.
Description:
Substance use disorders (SUDs) continue to be one of the most serious public health problems
in the US. Studies have consistently documented a substantially higher prevalence of SUDs
among adults under criminal justice supervision in the community (i.e., probation or parole)
as compared to the general population. There is growing recognition that addiction is a
chronic health condition, and individuals with SUDs typically cycle through multiple periods
of treatment, abstinence, and relapse over several years to achieve and maintain recovery.
Studies show that continuing care interventions can provide ongoing support or extend primary
treatment gains with respect to reducing substance use, relapse, and criminal activity.
Recent diffusion of Internet and smartphone technologies among disadvantaged populations now
offers unprecedented opportunities for increasing access to quality continuing care
interventions as well as chronic disease self-management tools. Probationers and parolees at
high risk for drug abuse relapse and involvement in health compromising behaviors are an
important population that stands to benefit from continuing care technologies. However, to
date, no such technologies exist that are specifically tailored to meet the unique needs of
this high-risk population.
Building on our team's extensive experience in the fields of criminology and substance use,
we propose to complete the development of a Continuing Care mobile application (app) and
conduct a randomized controlled trial to assess efficacy among clients on probation or parole
who are enrolled in outpatient substance use treatment. The app is designed to meet the
recovery and personal support needs of probationers and parolees with SUDs who are at
elevated risk of relapse, re-arrest, and incarceration. It is guided by the principles of the
transtheoretical model of behavior change and app content is derived from the Your Own
Reintegration System (YOURS) program, an empirically-supported16 intervention that focuses on
substance use recovery, reducing criminal thinking and behavior, and managing and building
support systems. If proven to be efficacious, the app could be deployed across the national
network of outpatient treatment providers, and be highly significant in its direct impact on
public health.