Reentry Assist (R-Assist)

NCT ID: NCT06980233

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-09-29

Brief Summary

This project will aim to develop and pilot test, R-Assist, a mobile health application to support individuals with co-occurring substance use and mental health disorders (COD) in their recovery, who have recently released from a participating Massachusetts jail.

Detailed Description

This Phase I project will develop and test an mHealth app called R-Assist among individuals with COD recently released from a Massachusetts jail. R-Assist will offer four core features, including linkages to community resources via the resource locator, on demand, tailored self-help materials, and self-management/organizational tools. The following two Aims will be tested: Aim 1. R-Assist software and content prototype development. The 4 R-Assist features will include: 1) daily self-reported symptom and medication management monitoring; 2) a 29-session self-help curriculum, with an accompanying library of recovery resources to support COD symptom management and promote prosocial thinking and behavior; 3) social determinants of health (SDOH) resource finder; and 4) a dashboard to track R-Assist engagement. Aim 2. A successive cohort study of the R-Assist prototype with participants who have recently left jail (N = 38). This will include three successive field focus group cohorts with 18 participants, followed by a small open pilot with 20 participants. This project's four milestones will be executed in preparation for a larger Phase II trial.

• Milestone 1 (Months 1-5): R-Assist App Development and Interface Designs

o No human subjects involvement

• Milestone 2 (Months 6-7): Initial Evaluation/Refinement of R-Assist

o To recruit N=18 individuals for this Milestone

• Milestone 3 (Months 8-10): Open Pilot of R-Assist

o To recruit recruit N=20 individuals for this Milestone

• Milestone 4 (Months 11-12): Product Refinement Prior to Phase II and Dissemination o No human subjects involvement

Conditions

Substance Use Disorder (SUD); Mental Health Disorder; Criminal Recidivism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R-Assist

Participants who have recently released from jail will engage with the R-assist app for up to 1.5 months

Group Type: EXPERIMENTAL

reentry assistance mobile health app

Intervention Type: BEHAVIORAL

R-Assist features will include: 1) daily self-reported symptom and medication management monitoring; 2) a 29-session MISSION-CJ self-help curriculum, with an accompanying library of recovery resources to support COD symptom management and promote prosocial thinking and behavior; 3) SDOH resource finder; and 4) a dashboard to track R-Assist engagement.

Interventions

reentry assistance mobile health app

R-Assist features will include: 1) daily self-reported symptom and medication management monitoring; 2) a 29-session MISSION-CJ self-help curriculum, with an accompanying library of recovery resources to support COD symptom management and promote prosocial thinking and behavior; 3) SDOH resource finder; and 4) a dashboard to track R-Assist engagement.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Have been released from the participating jail within the past 150 days
• Own a smartphone (Android or iOS; 90% met this criterion in our prior studies)
• Have COD: any substance use disorder (we will allow poly-substance use disorders) and a co-occurring mental health disorder (depression, anxiety, trauma related disorders, bipolar, and/or schizophrenia)
• Consent to R-Assist app use observation and e-tracking
• Consent to audio recording during interviews and focus groups.

Exclusion Criteria

• Acutely suicidal, homicidal, or psychotic
• Unable to provide informed consent
• Individuals released with monitoring devices or individuals involved in drug treatment courts

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: collaborator

Meaningful Measurement, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Smelson, PsyD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts Chan Medical School

Donna Surges Tatum, PhD

Role: PRINCIPAL_INVESTIGATOR

Meaningful Measurement, LLC

Central Contacts

David Smelson, PsyD

Role: CONTACT

David.Smelson@umassmed.edu

508-713-5420

Paige Shaffer, PhD

Role: CONTACT

paige.shaffer@umassmed.edu

Other Identifiers

R41DA061403

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001884

Identifier Type: -

Identifier Source: org_study_id