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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03962348
Other study ID # NYSPI 7771 - 251051
Secondary ID R34MH117766
Status Completed
Phase N/A
First received
Last updated
Start date January 8, 2020
Est. completion date March 2, 2023

Study information

Verified date June 2023
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date March 2, 2023
Est. primary completion date March 2, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 30 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Specialized Early Engagement Support Service
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).

Locations

Country Name City State
United States Rikers Island Jails (Anna M. Kross Center, Rose M. Singer Center, and Robert N. Davoren Complex) E. Elmhurst New York

Sponsors (5)

Lead Sponsor Collaborator
Columbia University National Institute of Mental Health (NIMH), University of Illinois at Chicago, University of South Florida, Vera Institute of Justice

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 Years
Primary Number of Referrals to Coordinated Specialty Care (CSC) Number individuals found to have first-episode psychosis enrolled in CSC upon release from jail. 2 years
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