Supporting Treatment Access and Recovery Through Linkage and Support
STAR-LS
Rigorous Evaluation of Strategies to Prevent Overdose Through Linking People With Illicit Substance Use Disorder to Recovery Support Services
1 other identifier
interventional
208
1 country
1
Brief Summary
This 3-year Hybrid Type 1 study will randomize 208 people with co-occurring substance use and mental health disorders (COD) referred from the Worcester Hub. This study seeks to evaluate the effectiveness of MISSION, a multi-component team approach, versus linkage with a Peer Specialist on improving outcomes among individuals with CODs. We expect that individuals receiving MISSION versus linkage only will show greater improvement in treatment engagement, substance use, and mental health outcomes. This study will also concurrently conduct a process evaluation to inform sustainability and future implementation of such interventions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2023
CompletedFirst Posted
Study publicly available on registry
February 6, 2023
CompletedStudy Start
First participant enrolled
May 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
April 13, 2026
April 1, 2026
3.3 years
January 27, 2023
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (56)
Self-report opioid use and other substance use
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Baseline
Self-report opioid use and other substance use
Measured by self-report days of use using the Time-line Follow Back (TLFB)
3-months
Self-report opioid use and other substance use
Measured by self-report days of use using the Time-line Follow Back (TLFB)
6-months
Self-report opioid use and other substance use
Measured by self-report days of use using the Time-line Follow Back (TLFB)
9-months
Mental Health Functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Baseline
Mental Health Functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
3-months
Mental Health Functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
6-months
Mental Health Functioning
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
9-months
PTSD Symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Baseline
PTSD Symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
3-months
PTSD Symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
6-months
PTSD Symptoms
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
9-months
Mental Health Impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Baseline
Mental Health Impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
3-months
Mental Health Impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
6-months
Mental Health Impairment
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
9-months
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Screening
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Baseline
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
3-months
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
6-months
Psychiatric Severity
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
9-months
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Baseline
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
3-months
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
6-months
Health functioning
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
9-months
Therapeutic Alliance Client
Measured by Working Alliance Inventory-C
Baseline
Therapeutic Alliance Client
Measured by Working Alliance Inventory-C
3-months
Therapeutic Alliance Client
Measured by Working Alliance Inventory-C
6-months
Therapeutic Alliance Client
Measured by Working Alliance Inventory-C
9-months
Therapeutic Alliance Therapist
Measured by Working Alliance Inventory-T
Baseline
Therapeutic Alliance Therapist
Measured by Working Alliance Inventory-T
3-months
Therapeutic Alliance Therapist
Measured by Working Alliance Inventory-T
6-months
Therapeutic Alliance Therapist
Measured by Working Alliance Inventory-T
9-months
Recovery Capital
Measured by Assessment of Recovery Capital (ARC)
Baseline
Recovery Capital
Measured by Assessment of Recovery Capital (ARC)
3-months
Recovery Capital
Measured by Assessment of Recovery Capital (ARC)
6-months
Recovery Capital
Measured by Assessment of Recovery Capital (ARC)
9-months
Alcohol or other drug 12-Step Participation
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Baseline
Alcohol or other drug 12-Step Participation
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
3-months
Alcohol or other drug 12-Step Participation
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
6-months
Alcohol or other drug 12-Step Participation
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
9-months
Overdose Risk
Self-report using the Overdose Risk Questionnaire (OdRi)
Baseline
Overdose Risk
Self-report using the Overdose Risk Questionnaire (OdRi)
3-months
Overdose Risk
Self-report using the Overdose Risk Questionnaire (OdRi)
6-months
Overdose Risk
Self-report using the Overdose Risk Questionnaire (OdRi)
9-months
Number of Outreach and Linkage Sessions
Self-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
Baseline
Number of Outreach and Linkage Sessions
Self-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
3-months
Number of Outreach and Linkage Sessions
Self-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
6-months
Number of Outreach and Linkage Sessions
Self-reported using the Psychosocial Treatment \& Healthcare Services Tracking Sheet
9-months
Baseline Demographics
Self-reported using the Addiction Severity Index (ASI)
Baseline
Suicide Severity
Self-report using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Screening
Community Health & Social Needs
Self-report using the Accountable Health Communities \& Health-Related Social Needs
Baseline
Fidelity to Intervention
Measured via clinical staff submitting weekly treatment fidelity logs
Weekly
Acceptability & Appropriateness
Using the The Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM)
6-months
Feasibility of Intervention
Using the Feasibility of Intervention Measure (FIM)
6-months
Satisfaction with Care
Self-report using the Treatment Satisfaction Questionnaire
6-months
Study Arms (2)
Full MISSION
EXPERIMENTALParticipants assigned to this condition will receive full MISSION services. MISSION services include 6-months of integrated mental health and substance use treatment and treatment planning with the MISSION Case Manager (13 session curriculum) and Peer Support Specialist (11 session curriculum). Content of these sessions will be directed using the MISSION Treatment Manual and Consumer Workbooks. MISSION teams will also provide linkages and supports to treatment services within the participant's community throughout the duration of the study.
Linkage Only Delivered by a Peer Specialist
ACTIVE COMPARATOROur Linkage only arm delivered by a Peer Specialist will act as the comparison group to the MISSION arm. Participants randomized to the linkage only arm will receive 6-months of linkage care from a Peer Specialist. The Peer Specialist will provide informal treatment planning as well as linkages and support to community services, but will not provide integrated dual disorders treatment, nor will this arm utilize any MISSION materials or offer Peer led groups.
Interventions
MISSION is a time-limited, cross disciplinary, team-based wraparound approach that provides 6 months of psychosocial treatment combined with assertive outreach, empowering clients to access and engage in care and community services to promote recovery. The MISSION treatment curriculum integrates 3 evidence-based practices: 1) Critical Time Intervention (CTI), a time-limited form of assertive community treatment; 2) Dual Recovery Therapy (DRT), which is integrated mental health and substance use group therapy; and 3) Peer Support (PS), offering support for people in recovery by people in recovery.
Linkage only is provided via Peer Specialists whom have lived experiences similar to that of our participants. Linkage only includes informal treatment planning and linkages and supports to needed community services.
Eligibility Criteria
You may qualify if:
- Are 18 or older;
- Have a COD (1 or more substance use disorders (e.g., alcohol and illicit substances), and a mental health disorder (including depression, anxiety, trauma related disorders, bipolar, and/or schizophrenia);
- Are in the Hub; and
- Are not engaged in other ongoing multi-component treatment for COD with a behavioral health treatment provider or have not seen their provider for at least 3 months.
You may not qualify if:
- We will exclude individuals who are acutely psychotic, acutely suicidal with a plan, or homicidal
- Or with concurrent severe alcohol use disorder or high dose benzodiazepine requiring detoxification.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Massachusetts, Worcesterlead
- Centers for Disease Control and Preventioncollaborator
- University of Massachusetts, Lowellcollaborator
- University of Massachusetts, Amherstcollaborator
Study Sites (1)
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Smelson, PsyD
University of Massachusetts, Worcester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 27, 2023
First Posted
February 6, 2023
Study Start
May 24, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- De-identified data will be shared with qualified and approved researchers via an appropriate data repository. Research data will be destroyed 6 years after the end of the Fiscal Year in which the study is completed. The master list of identifiers will be destroyed at the 6-year mark or when all statistical analyses have been completed and scientific papers have been published, whichever comes first.
- Access Criteria
- We will share findings with colleagues who have a demonstrable, legitimate scientific interest that may be addressed by research findings.
Consistent with Health and Human Services/Center for Disease Control and Prevention (CDC) policy, research resources and data will be made readily available for research purposes to qualified individuals within the scientific community after publication of any scholarly work. Scholarly publications will also be immediately available to the public on PubMed Central. Additionally, raw and analyzed de-identified data used in publications will be responsibly shared through submissions to a CDC-approved data repository. Other methods for data sharing will be via presentations at professional conferences and, as findings permit, disclosure of summary data to professionals and the general public. To the extent feasible and appropriate, we will share pre-publication findings with colleagues who have a demonstrable, legitimate scientific interest that may be addressed by research findings. We expect to further disseminate the study via gray literature and the project website.