Clinical Interviews With Detainees With Early Psychosis (Interview)

June 20, 2023 updated by: Michael Compton, Columbia University

Reducing Duration of Untreated Psychosis Through Early Detection in a Large Jail System - Clinical Interviews With Detainees With Early Psychosis

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • E. Elmhurst, New York, United States, 11370
        • Rikers Island Jails (Anna M. Kross Center, Rose M. Singer Center, and Robert N. Davoren Complex)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Specialized Early Engagement Support Service
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Referrals to Correctional Health Services (CHS)
Time Frame: 2 Years
This primary measure reports the numbers of referrals of detainees with early psychosis from the Rikers project.
2 Years
Number of Referrals to Coordinated Specialty Care (CSC)
Time Frame: 2 years
Number individuals found to have first-episode psychosis enrolled in CSC upon release from jail.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael T Compton, MD, MPH, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2020

Primary Completion (Actual)

March 2, 2022

Study Completion (Actual)

March 2, 2023

Study Registration Dates

First Submitted

May 19, 2019

First Submitted That Met QC Criteria

May 21, 2019

First Posted (Actual)

May 24, 2019

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • NYSPI 7771 - 251051
  • R34MH117766 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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