Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 8:18 PM
Study NCT ID:
NCT06980233
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-25
First Post:
2025-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reentry Assist (R-Assist)
Sponsor:
Meaningful Measurement, Inc
Organization:
Study Overview
Official Title:
Reentry-Assist App Development for Individuals With Addiction and Mental Illness
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
R-Assist
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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R41DA061403 | NIH | None | https://reporter.nih.gov/quic… | View |