- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06980233
- Original Trial
Reentry Assist (R-Assist) (R-Assist)
Reentry-Assist App Development for Individuals With Addiction and Mental Illness
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01605
- University of Massachusetts Chan Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: R-Assist
Participants who have recently released from jail will engage with the R-assist app for up to 1.5 months
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
App usage
Time Frame: 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
|
From enrollment for 1.5 months during the open pilot
|
|
System Usability Scale (SUS)
Time Frame: 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.
|
From enrollment for 1.5 months during the open pilot
|
|
Mobile Application Rating Scale (MARS)
Time Frame: 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"
|
From enrollment for 1.5 months during the open pilot
|
|
Composite International Diagnostic Instrument for DSM-IV: Social determinants of health (SDOH) linkages
Time Frame: 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.
|
From enrollment for 1.5 months during the open pilot
|
|
Composite International Diagnostic Instrument for DSM-IV: Substance Use Disorder
Time Frame: From enrollment for 1.5 months during the open pilot
|
Substance use disorder symptoms will be tracked daily during the open pilot period.
|
From enrollment for 1.5 months during the open pilot
|
|
Composite International Diagnostic Instrument for DSM-IV: Mental Health
Time Frame: From enrollment for 1.5 months during the open pilot
|
Mental health symptoms will be tracked daily during the open pilot period.
|
From enrollment for 1.5 months during the open pilot
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Smelson, PsyD, University of Massachusetts Chan Medical School
- Principal Investigator: Donna Surges Tatum, PhD, Meaningful Measurement, LLC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001884
- R41DA061403 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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