NCT03962348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

January 8, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
4 months until next milestone

Results Posted

Study results publicly available

June 22, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

2.1 years

First QC Date

May 19, 2019

Results QC Date

February 13, 2023

Last Update Submit

June 20, 2023

Conditions

Keywords

DetaineesEarly Psychosis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Specialized Early Engagement Support Service

EXPERIMENTAL

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.

Behavioral: Specialized Early Engagement Support Service

Interventions

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).

Specialized Early Engagement Support Service

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • children under the age of 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikers Island Jails (Anna M. Kross Center, Rose M. Singer Center, and Robert N. Davoren Complex)

East Elmhurst, New York, 11370, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Limitations and Caveats

This was a very small study, and statistical analyses were therefore not conducted.

Results Point of Contact

Title
Dr. Michael Compton
Organization
Columbia University Irving Medical Center

Study Officials

  • Michael T Compton, MD, MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Feasibility and Acceptability Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

May 19, 2019

First Posted

May 24, 2019

Study Start

January 8, 2020

Primary Completion

March 2, 2022

Study Completion

March 2, 2023

Last Updated

June 22, 2023

Results First Posted

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

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

Time Frame
To be determined
Access Criteria
To be determined

Locations