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Reentry Assist (R-Assist)

M

Meaningful Measurement, Inc

Status

Not yet enrolling

Conditions

Criminal Recidivism
Mental Health Disorder
Substance Use Disorder (SUD)

Treatments

Behavioral: reentry assistance mobile health app

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT06980233
STUDY00001884
R41DA061403 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment

38 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

38 participants in 1 patient group

R-Assist
Experimental group
Description:
Participants who have recently released from jail will engage with the R-assist app for up to 1.5 months
Treatment:
Behavioral: reentry assistance mobile health app

Trial contacts and locations

0

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Central trial contact

Paige Shaffer, PhD; David Smelson, PsyD

Data sourced from clinicaltrials.gov

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