Continuing Care App for Probationers and Parolees

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-08

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Developing SUPPORT, a Community-Driven, Recovery-Oriented System of Care

NCT03132753

Substance Use

COMPLETED NA

Treating Polysubstance Use Using a Novel Digital Technology

NCT05766631

Opioid Use Opioid Use Disorder Cocaine Use +1 more

RECRUITING PHASE3

A Stepped-Wedge Cluster Randomized Trial of a Digital App to Support Medication-Assisted Treatment in Individuals With Opioid Use Disorder

NCT07140926

Opioid Use Disorder

COMPLETED NA

Implementing Contingency Management for Stimulant Use in Specialty Addiction Treatment Organizations

NCT05702021

Stimulant Use (Diagnosis)

RECRUITING NA

Contingency Management Using Smartphone App in Patients With SUD

NCT04162132

Substance Use Disorders

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Substance Use Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

digital therapeutic for substance use disorders

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Treatment As Usual

Intervention Type OTHER

12-weeks of weekly group cognitive behavioral therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Treatment As Usual

12-weeks of weekly group cognitive behavioral therapy

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes