First-Episode PsychosisInterviewNCT03962348
Clinical Interviews With Detainees With Early Psychosis
A study testing Specialized Early Engagement Support Service in people with First-Episode Psychosis, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- First-Episode Psychosis
- What is being tested?
- Specialized Early Engagement Support Service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2020to 2 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- children under the age of 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Rikers Island Jails (Anna M. Kross Center, Rose M. Singer Center, and Robert N. Davoren Complex)
East Elmhurst, New York, 11370
About this study
Official title: 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.
Read the 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.
- Conditions
- First-Episode Psychosis
- Being tested
- Specialized Early Engagement Support Service
- Keywords
- Detainees, Early Psychosis
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized Early Engagement Support ServiceBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Specialized Early Engagement Support Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start8 Jan 2020
- Primary completion2 Mar 2022
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for First-Episode PsychosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Feasibility and Acceptability Study
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Vera Institute of Justice, University of Illinois Chicago, University of South Florida, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Michael Compton, Columbia University
- Investigators
- Michael T Compton, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962348
- Sponsor's protocol ID
- NYSPI 7771 - 251051
- Other IDs
- R34MH117766
- Acronym
- Interview
- Status last verified
- Jun 2023
- First submitted
- 19 May 2019
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Duration of Untreated Psychosis Through Early Detection in a Large Jail System - Clinical Interviews With Detainees With Early Psychosis
- ClinicalTrials.gov ID
- NCT03962348
- Acronym / sponsor ID
- Interview / NYSPI 7771 - 251051
- Conditions
- First-Episode Psychosis
- Keywords
- Detainees, Early Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Vera Institute of Justice, University of Illinois Chicago, University of South Florida, National Institute of Mental Health (NIMH)
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility and Acceptability Study
| Arm | Type | Receives |
|---|---|---|
| Specialized Early Engagement Support Service | Experimental | Behavioral: Specialized Early Engagement Support ServiceThe 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- children under the age of 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specialized Early Engagement Support ServiceThe 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). | Behavioural | Specialized Early Engagement Support Service |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael T Compton, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialized Early Engagement Support Service in people with First-Episode Psychosis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Referrals to Correctional Health Services (CHS) (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.