Clinical trial NCT06980233: Reentry Assist (R-Assist)
Official title: Reentry-Assist App Development for Individuals With Addiction and Mental Illness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Substance Use Disorder (SUD)
Mental Health Disorder
Criminal Recidivism
Keywords: substance use disorder
mental health
criminal-legal involvement
Lead sponsor: Meaningful Measurement, Inc
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Massachusetts, Worcester
First posted: 2025-05-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: App usage
timeFrame: From enrollment for 1.5 months during the open pilot
measure: System Usability Scale (SUS)
timeFrame: From enrollment for 1.5 months during the open pilot
measure: Mobile Application Rating Scale (MARS)
timeFrame: From enrollment for 1.5 months during the open pilot
measure: Composite International Diagnostic Instrument for DSM-IV: Social determinants of health (SDOH) linkages
timeFrame: From enrollment for 1.5 months during the open pilot
measure: Composite International Diagnostic Instrument for DSM-IV: Substance Use Disorder
timeFrame: From enrollment for 1.5 months during the open pilot
measure: Composite International Diagnostic Instrument for DSM-IV: Mental Health
timeFrame: From enrollment for 1.5 months during the open pilot
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Massachusetts Chan Medical School
name: David Smelson, PsyD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meaningful Measurement, LLC
name: Donna Surges Tatum, PhD
role: PRINCIPAL_INVESTIGATOR
References: