Substance Use Disorder (SUD)R-AssistNCT06980233
Reentry Assist (R-Assist)
A study testing reentry assistance mobile health app in people with Substance Use Disorder (SUD) and Mental Health Disorder, run by Meaningful Measurement, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorder (SUD), Mental Health Disorder, Criminal Recidivism
- What is being tested?
- reentry assistance mobile health app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Acutely suicidal, homicidal, or psychotic
- Unable to provide informed consent
- Individuals released with monitoring devices or individuals involved in drug treatment courts
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01605
About this study
Official title: Reentry-Assist App Development for Individuals With Addiction and Mental Illness
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.
Read the 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
- No human subjects involvement
- Milestone 2 (Months 6-7): Initial Evaluation/Refinement of R-Assist
- To recruit N=18 individuals for this Milestone
- Milestone 3 (Months 8-10): Open Pilot of R-Assist
- 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
- Being tested
- reentry assistance mobile health app
- Keywords
- substance use disorder, mental health, criminal-legal involvement
- Medical subject headings
- Substance-Related Disorders, Mental Disorders, Recidivism, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reentry assistance mobile health appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| R-Assist | Experimental | Participants who have recently released from jail will engage with the R-assist app for up to 1.5 months Receives: Behavioral: reentry assistance mobile health app |
What is being measured
The primary outcome is the main question the study is designed to answer.
App usage
Total time engaged in app will be tracked daily during open pilot period. Additionally, engagement and time with each feature will be tracked
Measured: From enrollment for 1.5 months during the open pilot
System Usability Scale (SUS)
Overall score will be computed, indicating overall usability Score ranges from 0-100 (0-64=not acceptable, 65-84=acceptable, and 85, 100=excellent.
Measured: From enrollment for 1.5 months during the open pilot
Mobile Application Rating Scale (MARS)
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"
Measured: From enrollment for 1.5 months during the open pilot
Composite International Diagnostic Instrument for DSM-IV: Social determinants of health (SDOH) linkages
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.
Measured: From enrollment for 1.5 months during the open pilot
Composite International Diagnostic Instrument for DSM-IV: Substance Use Disorder
Substance use disorder symptoms will be tracked daily during the open pilot period.
Measured: From enrollment for 1.5 months during the open pilot
Composite International Diagnostic Instrument for DSM-IV: Mental Health
Mental health symptoms will be tracked daily during the open pilot period.
Measured: From enrollment for 1.5 months during the open pilot
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Jun 2025
- Primary completion31 Mar 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meaningful Measurement, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Massachusetts, Worcester
- Responsible party
- Sponsor
- Investigators
- David Smelson, PsyD, Principal investigator, University of Massachusetts, WorcesterDonna Surges Tatum, PhD, Principal investigator, Meaningful Measurement, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980233
- Sponsor's protocol ID
- STUDY00001884
- Other IDs
- R41DA061403
- Acronym
- R-Assist
- Status last verified
- Oct 2026
- First submitted
- 12 May 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reentry-Assist App Development for Individuals With Addiction and Mental Illness
- ClinicalTrials.gov ID
- NCT06980233
- Acronym / sponsor ID
- R-Assist / STUDY00001884
- Keywords
- substance use disorder, mental health, criminal-legal involvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Meaningful Measurement, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Massachusetts, Worcester
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- No human subjects involvement
- Milestone 2 (Months 6-7): Initial Evaluation/Refinement of R-Assist
- To recruit N=18 individuals for this Milestone
- Milestone 3 (Months 8-10): Open Pilot of R-Assist
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| R-Assist | Experimental | Behavioral: reentry assistance mobile health appParticipants who have recently released from jail will engage with the R-assist app for up to 1.5 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Acutely suicidal, homicidal, or psychotic
- Unable to provide informed consent
- Individuals released with monitoring devices or individuals involved in drug treatment courts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reentry assistance mobile health appR-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. | Behavioural | R-Assist |
Primary outcome
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
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.
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"
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Smelson, PsyD principal investigator
University of Massachusetts, Worcester
Donna Surges Tatum, PhD principal investigator
Meaningful Measurement, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reentry assistance mobile health app in people with Substance Use Disorder (SUD) and Mental Health Disorder, run by Meaningful Measurement, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
App usage (time frame: From enrollment for 1.5 months during the open pilot). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.