Continuing Care App for Probationers and Parolees

Continuing Care App for Probationers and Parolees With Substance Use Disorders

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.

Study Overview

• Status: Completed
• Conditions: Substance Use Disorders
• Intervention / Treatment: Device: digital therapeutic for substance use disorders; Other: Treatment As Usual

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • REACH Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18 or older
• Currently on community supervision (probation or parole) or justice-involvement in the past 12 months
• Currently a client receiving outpatient substance use treatment
• Willing to receive supplemental treatment services through a mobile app
• Willing to provide informed consent and complete research assessments

Exclusion Criteria:

• Severe psychiatric problems (e.g., untreated psychosis, untreated bipolar disorder)
• Suicidality within the past 6-months, as determined by clinical staff, which could make participation in a novel treatment hazardous

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weeks Retained in Substance Use Treatment	Number of weeks retained in treatment based on a review of clinical records	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of Substance Use Treatment	Treatment completed (yes or no) based on a review of clinical records	up to 12 weeks
Days of Substance Use	Number of days of drug use based on self-report drug use and urine drug screen results	up to 18 weeks
Days of Criminal Activity; Re-arrest; Incarceration	Number of crime days; re-arrest (yes or not); incarceration (yes or no) based on self-report information and public court record databases	up to 18 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rating of App Satisfaction	Rating of client satisfaction using the app based on self-report information	up to 12 weeks

Collaborators and Investigators

• Sponsor: COG Analytics
• Collaborators: Friends Research Institute, Inc.
• Investigators: Principal Investigator: Steven B Carswell, Ph.D., COG Analytics

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2R44MD008848-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: COG Analytics (COG) and Friends Research Institute (FRI) are committed to the open and timely dissemination of research outcomes. Investigators in the proposed study recognize that promising new methods, technologies, strategies and computer software may arise during the course of this research. The investigators are aware of, and agree to abide by, the principles for sharing research resources as described by the National Institutes of Health (NIH) in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources."

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No