Continuing Care App for Probationers and Parolees

Substance Use Disorders Clinical Trial

Official title:

Continuing Care App for Probationers and Parolees With Substance Use Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04574193
• Other study ID #: 2R44MD008848-02
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Other:
• Treatment As Usual
12-weeks of weekly group cognitive behavioral therapy

Locations

Country	Name	City	State
United States	REACH Health Services	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
COG Analytics	Friends Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rating of App Satisfaction	Rating of client satisfaction using the app based on self-report information	up to 12 weeks
Primary	Weeks Retained in Substance Use Treatment	Number of weeks retained in treatment based on a review of clinical records	up to 12 weeks
Secondary	Completion of Substance Use Treatment	Treatment completed (yes or no) based on a review of clinical records	up to 12 weeks
Secondary	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
Secondary	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