Reentry Assist (R-Assist)

Not Applicable

Not yet recruiting

• Conditions: Substance Use Disorder (SUD); Mental Health Disorder; Criminal Recidivism

• Registration Number: NCT06980233
• Lead Sponsor: Meaningful Measurement, Inc

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

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-12
• Study First Posted: 2025-05-20
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25
• Study Start: 2025-06-01
• Primary Completion: 2025-08-31
• Study Completion: 2025-09-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mobile Application Rating Scale (MARS)	From enrollment for 1.5 months during the open pilot	Overall score will be computed, indicating overall acceptability, as well as score for each of the four dimensions. The rating scale assesses app quality on four dimensions (1. Engagement, 2. Functionality, 3. Aesthetics, and 4. Information). All items are rated on 5-point scale from "1=inadequate" to "5=excellent"
Composite International Diagnostic Instrument for DSM-IV: Social determinants of health (SDOH) linkages	From enrollment for 1.5 months during the open pilot	SDOH needs (e.g., housing instability, food insecurity, NA/AA/ other recovery linkages) will be assessed and the App will track all referrals and SDOH linkages made. Percent of linkages made to needed SDOH services will be examined.
Composite International Diagnostic Instrument for DSM-IV: Substance Use Disorder	From enrollment for 1.5 months during the open pilot	Substance use disorder symptoms will be tracked daily during the open pilot period.
Composite International Diagnostic Instrument for DSM-IV: Mental Health	From enrollment for 1.5 months during the open pilot	Mental health symptoms will be tracked daily during the open pilot period.
App usage	From enrollment for 1.5 months during the open pilot	Total time engaged in app will be tracked daily during open pilot period. Additionally, engagement and time with each feature will be tracked
System Usability Scale (SUS)	From enrollment for 1.5 months during the open pilot	Overall score will be computed, indicating overall usability Score ranges from 0-100 (0-64=not acceptable, 65-84=acceptable, and 85, 100=excellent.