Continuing Care App for Probationers and Parolees
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|ClinicalTrials.gov Identifier: NCT04574193|
Recruitment Status : Not yet recruiting
First Posted : October 5, 2020
Last Update Posted : January 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Substance Use Disorders||Device: digital therapeutic for substance use disorders Other: Treatment As Usual||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The evaluation will involve a two-group RCT in which 100 men and women on probation or parole, who are currently receiving outpatient substance use treatment at THC, will be randomly assigned to one of two conditions: (1) Continuing Care app (CC app; n=50): Participants will receive the CC app, in addition to usual care at the treatment program (12-weeks of weekly group cognitive behavioral therapy), or (2) Treatment As Usual (TAU; n=50): Participants will only receive 12-weeks of weekly group cognitive behavioral therapy.|
|Masking:||None (Open Label)|
|Official Title:||Continuing Care App for Probationers and Parolees With Substance Use Disorders|
|Estimated Study Start Date :||February 8, 2021|
|Estimated Primary Completion Date :||August 5, 2021|
|Estimated Study Completion Date :||November 5, 2021|
Experimental: Continuing Care App
Participants will receive the Continuing Care app, in addition to usual care at the treatment program (12-weeks of weekly group cognitive behavioral therapy).
Device: digital therapeutic for substance use disorders
The Continuing Care application (app) is a HIPAA-compliant, mobile-friendly, software program 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.
Active Comparator: Treatment As Usual
Participants will only receive 12-weeks of weekly group cognitive behavioral therapy.
Other: Treatment As Usual
12-weeks of weekly group cognitive behavioral therapy
- Weeks Retained in Substance Use Treatment [ Time Frame: up to 12 weeks ]Number of weeks retained in treatment based on a review of clinical records
- Completion of Substance Use Treatment [ Time Frame: up to 12 weeks ]Treatment completed (yes or no) based on a review of clinical records
- Days of Substance Use [ Time Frame: up to 18 weeks ]Number of days of drug use based on self-report drug use and urine drug screen results
- Days of Criminal Activity; Re-arrest; Incarceration [ Time Frame: up to 18 weeks ]Number of crime days; re-arrest (yes or not); incarceration (yes or no) based on self-report information and public court record databases
- Rating of App Satisfaction [ Time Frame: up to 12 weeks ]Rating of client satisfaction using the app based on self-report information
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04574193
|Contact: Steven B Carswell, Ph.D.||410-837-3977 ext email@example.com|
|Contact: Michael S Gordon, D.P.A.||410-837-3977 ext firstname.lastname@example.org|
|Principal Investigator:||Steven B Carswell, Ph.D.||COG Analytics|