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Reducing DUP Through Early Detection in a Large Jail System

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ClinicalTrials.gov Identifier: NCT03962348
Recruitment Status : Suspended (This study is temporarily suspended due to COVID-19 pandemic.)
First Posted : May 24, 2019
Last Update Posted : April 21, 2020
Sponsor:
Collaborators:
Vera Institute of Justice
University of Illinois at Chicago
University of South Florida
Information provided by (Responsible Party):
Michael Compton, New York State Psychiatric Institute

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: (1) a targeted education campaign for correction officers in three New York City jails; and (2) a jail-based Specialized Early Engagement Team 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.

Condition or disease Intervention/treatment Phase
First-Episode Psychosis Behavioral: Targeted Educational Campaign Behavioral: Specialized Early Engagement Team Not Applicable

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: (1) a "Targeted Educational Campaign" (TEC), and (2) a Specialized Early Engagement Team (SEET) 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 our DUP-1 (psychosis onset to antipsychotic initiation). Then, the jail-based SEET (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 SEET 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Feasibility and Acceptability Study
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Reducing Duration of Untreated Psychosis Through Early Detection in a Large Jail System
Actual Study Start Date : January 6, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Targeted Educational Campaign (TEC) for Correction Officers
The investigators will implement a Targeted Educational Campaign (TEC) within 3 jails at New York City's Rikers Island. The TEC is designed to lead to referrals of detainees (previously not detected as having potential mental health concerns) to Correctional Health Services (CHS) by Correction Officers.
Behavioral: Targeted Educational Campaign

Correction Officers will be exposed to the Targeted Educational Campaign (TEC) with the aim to increase their knowledge about the early symptoms of psychosis, and how to make a referral to the CHS staff, their self-efficacy to detect symptoms of psychosis and make referrals, and their expectations about their ability to be successful in making that referral (and for referrals to result in beneficial outcomes).

Correction Officers will be approached and recruited during roll call and in the staff canteen where they take their meal breaks, or at a time/location agreed upon by the Department of Correction, to complete brief surveys at three different times: pre-exposure, after 6 months, and after 12 months from the beginning of the TEC.


Experimental: Specialized Early Engagement Team
The investigators will implement a Specialized Early Engagement Team (SEET) in the same three jails. The SEET will increase the likelihood that referred individuals found to have first-episode psychosis enroll in Coordinated Specialty Care upon release.
Behavioral: Specialized Early Engagement Team
The Specialized Early Engagement Team (SEET - 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 Measures :
  1. Number of referrals to Correctional Health Services (CHS) due to the Targeted Educational Campaign (TEC) [ Time Frame: 2 Years ]
    Numbers of referrals of detainees (previously not detected as having potential mental health concerns) to CHS by Correction Officers.

  2. Number of referrals to Coordinated Specialty Care (CSC) [ Time Frame: 1 year ]
    Number individuals found to have first-episode psychosis enrolled in CSC upon release from jail.

  3. Acceptability of the jail-based TEC and SEET [ Time Frame: 2 Years ]
    Stakeholder qualitative interviews and focus groups with all relevant end-users of the new intervention (TEC+SEET).

  4. Feasibility of the jail-based TEC and SEET [ Time Frame: 2 Years ]
    (1) the number of detainees referred to the SEET, (2) the number of those referred who have FEP, (3) the DUP for this sample, and (4) the proportion who later engage in CSC.


Secondary Outcome Measures :
  1. Changes in Correction Officers' behavioral capability, expectations, and selfefficacy across the duration of the TEC [ Time Frame: 1 Year ]
    Changes in survey-based scores on behavioral capability (knowledge/skills), expectations, and self-efficacy (among Correction Officers) at baseline, 6-months, and 12-months.

  2. Survey-based engagement and working alliance between SEET and referred individuals [ Time Frame: 1 Year ]
    Positive correlation between scores of engagement and working alliance, and enrollment in CSC upon release.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CORRECTION OFFICERS:
  • exposure to the Targeted Educational Campaign
  • between the ages of 21 and 65 years
  • DETAINEES
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962348


Locations
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United States, New York
Rikers Island Jails (Anna M. Kross Center, Rose M. Singer Center, and Robert N. Davoren Complex)
E. Elmhurst, New York, United States, 11370
Sponsors and Collaborators
New York State Psychiatric Institute
Vera Institute of Justice
University of Illinois at Chicago
University of South Florida
Investigators
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Principal Investigator: Michael T Compton, M.D., P.H.D. Columbia University
  Study Documents (Full-Text)

Documents provided by Michael Compton, New York State Psychiatric Institute:
Informed Consent Form  [PDF] May 13, 2019

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Responsible Party: Michael Compton, Research Psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03962348    
Other Study ID Numbers: 7771
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data collected from this clinical trials research will be deposited into the National database for Clinical Trials Related to Mental Illness (NDCT). 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 Dr. Pauselli 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
Supporting Materials: Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: To be determined
Access Criteria: To be determined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders