search
Back to results

Continuing Care App for Probationers and Parolees

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
digital therapeutic for substance use disorders
Treatment As Usual
Sponsored by
COG Analytics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • REACH Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuing Care App

Treatment As Usual

Arm Description

Participants will receive the Continuing Care app, in addition to usual care at the treatment program (12-weeks of weekly group cognitive behavioral therapy).

Participants will only receive 12-weeks of weekly group cognitive behavioral therapy.

Outcomes

Primary Outcome Measures

Weeks Retained in Substance Use Treatment
Number of weeks retained in treatment based on a review of clinical records

Secondary Outcome Measures

Completion of Substance Use Treatment
Treatment completed (yes or no) based on a review of clinical records
Days of Substance Use
Number of days of drug use based on self-report drug use and urine drug screen results
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

Full Information

First Posted
September 14, 2020
Last Updated
October 4, 2023
Sponsor
COG Analytics
Collaborators
Friends Research Institute, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04574193
Brief Title
Continuing Care App for Probationers and Parolees
Official Title
Continuing Care App for Probationers and Parolees With Substance Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
COG Analytics
Collaborators
Friends Research Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuing Care App
Arm Type
Experimental
Arm Description
Participants will receive the Continuing Care app, in addition to usual care at the treatment program (12-weeks of weekly group cognitive behavioral therapy).
Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Description
Participants will only receive 12-weeks of weekly group cognitive behavioral therapy.
Intervention Type
Device
Intervention Name(s)
digital therapeutic for substance use disorders
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment As Usual
Intervention Description
12-weeks of weekly group cognitive behavioral therapy
Primary Outcome Measure Information:
Title
Weeks Retained in Substance Use Treatment
Description
Number of weeks retained in treatment based on a review of clinical records
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Completion of Substance Use Treatment
Description
Treatment completed (yes or no) based on a review of clinical records
Time Frame
up to 12 weeks
Title
Days of Substance Use
Description
Number of days of drug use based on self-report drug use and urine drug screen results
Time Frame
up to 18 weeks
Title
Days of Criminal Activity; Re-arrest; Incarceration
Description
Number of crime days; re-arrest (yes or not); incarceration (yes or no) based on self-report information and public court record databases
Time Frame
up to 18 weeks
Other Pre-specified Outcome Measures:
Title
Rating of App Satisfaction
Description
Rating of client satisfaction using the app based on self-report information
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven B Carswell, Ph.D.
Organizational Affiliation
COG Analytics
Official's Role
Principal Investigator
Facility Information:
Facility Name
REACH Health Services
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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."

Learn more about this trial

Continuing Care App for Probationers and Parolees

We'll reach out to this number within 24 hrs