Clinical Interviews With Detainees With Early Psychosis (Interview)
Primary Purpose
First-Episode Psychosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Specialized Early Engagement Support Service
Sponsored by
About this trial
This is an interventional health services research trial for First-Episode Psychosis focused on measuring Detainees, Early Psychosis
Eligibility Criteria
Inclusion Criteria:
- Detainees that have been referred by Correctional Health Services as experiencing early-course or first-episode psychosis
- between the ages of 18 and 30 years
- have a Mini-Mental State Examination (MMSE) score of >23
- have the capacity to provide informed consent for the study
- able to understand and speak English
Exclusion Criteria:
- children under the age of 18 years
Sites / Locations
- Rikers Island Jails (Anna M. Kross Center, Rose M. Singer Center, and Robert N. Davoren Complex)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Specialized Early Engagement Support Service
Arm Description
The investigators will implement a Specialized Early Engagement Support Service (SEESS) in the same three jails. The SEESS will increase the likelihood that referred individuals found to have first-episode psychosis enroll in Coordinated Specialty Care upon release.
Outcomes
Primary Outcome Measures
Number of Referrals to Correctional Health Services (CHS)
This primary measure reports the numbers of referrals of detainees with early psychosis from the Rikers project.
Number of Referrals to Coordinated Specialty Care (CSC)
Number individuals found to have first-episode psychosis enrolled in CSC upon release from jail.
Secondary Outcome Measures
Full Information
NCT ID
NCT03962348
First Posted
May 19, 2019
Last Updated
June 20, 2023
Sponsor
Columbia University
Collaborators
Vera Institute of Justice, University of Illinois at Chicago, University of South Florida, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03962348
Brief Title
Clinical Interviews With Detainees With Early Psychosis
Acronym
Interview
Official Title
Reducing Duration of Untreated Psychosis Through Early Detection in a Large Jail System - Clinical Interviews With Detainees With Early Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
March 2, 2022 (Actual)
Study Completion Date
March 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Vera Institute of Justice, University of Illinois at Chicago, University of South Florida, National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators are studying a jail-based intervention to reduce the duration of untreated psychosis (DUP) among young adults with previously undetected first-episode psychosis who are detained in jail. Longer DUP (or treatment delay) is linked to poorer outcomes in first-episode psychosis and there is evidence that justice-involved young adults with first-episode psychosis have an alarmingly long DUP. Thus, despite the expansion of Coordinated Specialty Care (CSC) programs that improve outcomes through early, multi-component care, there is a need to establish early detection services in the criminal justice system and create pathways from justice involvement to CSC. This intervention offers a novel and potentially high impact approach for reducing DUP in jail settings: a jail-based Specialized Early Engagement Support Service that receives referrals, engages detainees, and serves as a bridge to community-based CSC. The study team will design and implement the intervention, thoroughly study its feasibility and acceptability, and prepare an intervention manual for broader use in diverse jails and future formal research.
Detailed Description
Persons with serious mental illnesses are overrepresented in jails. Criminal justice (CJ) involvement, including jail detention, is common among those with first-episode psychosis (FEP) and frequently precedes psychiatric treatment engagement. Yet, no documented interventions currently exist specifically to identify/engage such individuals while in jail and connect them to Coordinated Specialty Care (CSC) in the community upon release. Expansion of CSC programs across the U.S. provides an opportunity for partnership with the CJ system-one that has the potential to reduce the duration of untreated psychosis (DUP) and thus improve outcomes.
To detect FEP and reduce DUP among detainees in a large, urban jail, the investigators propose to implement: a Specialized Early Engagement Support Service (SEESS) in 3 jails on Rikers Island in New York City (NYC): Anna M. Kross Center (AMKC), Rose M. Singer Center (RMSC) and Robert N. Davoren Complex (RNDC).
The investigators expect the multimedia TEC to generate referrals to the Correctional Health Services (CHS), and to reduce DUP-1 (psychosis onset to antipsychotic initiation). Then, the jail-based SEESS (a Social Worker and Peer Specialist) will link those identified to community-based CSC (primarily OnTrackNY sites in NYC), thus reducing DUP-2 (psychosis onset to CSC enrollment).
The investigators will examine a set of hypothesized targets/mediators (the "how's"). These are key ingredients that underpin the intervention's ability to reduce DUP.
The multi-media TEC will generate referrals to the CHS, by improving the behavioral capabilities, expectations, and self-efficacy (constructs from Social Cognitive Theory) of the Correction Officers trained. The SEESS will then link detainees with FEP, using tenets of person-centered treatment and shared decision-making, and the Critical Time Intervention model, to community-based CSC. This will occur through engagement of detainees while in jail, and telephonically (when possible) after release. The investigators will assess feasibility and acceptability to lay the groundwork for a multi-site, definitive effectiveness trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First-Episode Psychosis
Keywords
Detainees, Early Psychosis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Feasibility and Acceptability Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Specialized Early Engagement Support Service
Arm Type
Experimental
Arm Description
The investigators will implement a Specialized Early Engagement Support Service (SEESS) in the same three jails. The SEESS will increase the likelihood that referred individuals found to have first-episode psychosis enroll in Coordinated Specialty Care upon release.
Intervention Type
Behavioral
Intervention Name(s)
Specialized Early Engagement Support Service
Intervention Description
The Specialized Early Engagement Support Service (SEESS - a Social Worker and Peer Specialist) will link detainees with first-episode psychosis (FEP), using tenets of person-centered treatment and shared decision-making, and the Critical Time Intervention model, to community-based Coordinated Specialty Care (CSC).
Primary Outcome Measure Information:
Title
Number of Referrals to Correctional Health Services (CHS)
Description
This primary measure reports the numbers of referrals of detainees with early psychosis from the Rikers project.
Time Frame
2 Years
Title
Number of Referrals to Coordinated Specialty Care (CSC)
Description
Number individuals found to have first-episode psychosis enrolled in CSC upon release from jail.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Detainees that have been referred by Correctional Health Services as experiencing early-course or first-episode psychosis
between the ages of 18 and 30 years
have a Mini-Mental State Examination (MMSE) score of >23
have the capacity to provide informed consent for the study
able to understand and speak English
Exclusion Criteria:
children under the age of 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael T Compton, MD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rikers Island Jails (Anna M. Kross Center, Rose M. Singer Center, and Robert N. Davoren Complex)
City
E. Elmhurst
State/Province
New York
ZIP/Postal Code
11370
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data collected from this clinical trials research will be deposited into the National Institute of Mental Health Data Archive (NDA). In order to deposit the data, the investigators will use a consent form that allows broad data sharing within the research community. A global unique identifier (GUID) will be created for each research participant using the software that NIMH will provide. Dr. Compton and the research coordinator will work with NIMH to create data dictionaries that are relevant to their research. The investigators will share our results, positive and negative, specific to the cohorts and outcome measures studied
IPD Sharing Time Frame
To be determined
IPD Sharing Access Criteria
To be determined
Learn more about this trial
Clinical Interviews With Detainees With Early Psychosis
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