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Completed

NCT Number: NCT04574193

Continuing Care App for Probationers and Parolees

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

REACH Health Services

Baltimore, Maryland, 21218, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

digital therapeutic for substance use disorders

Device

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.

Treatment as Usual

Other

12-weeks of weekly group cognitive behavioral therapy

Primary outcomes

  1. 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

Secondary outcomes

  1. Completion of Substance Use Treatment

    Time frame: up to 12 weeks

    Treatment completed (yes or no) based on a review of clinical records

  2. 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

  3. 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

Other outcomes

  1. Rating of App Satisfaction

    Time frame: up to 12 weeks

    Rating of client satisfaction using the app based on self-report information

Sponsors and collaborators

Lead sponsor

COG Analytics

Other

Collaborators

  • Friends Research Institute, Inc.

Registry information

Official study title

Continuing Care App for Probationers and Parolees With Substance Use Disorders

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2020
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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