NCT04004364

Brief Summary

The goal if the project is to develop a learning health network devoted to the treatment of first episode psychosis.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

5 years

First QC Date

June 28, 2019

Last Update Submit

September 10, 2024

Conditions

First Episode Psychosis

Outcome Measures

Primary Outcomes (1)

  • Number of Enrolled participants

    Number of enrolled participants into the learning health system

    5 years of the project

Interventions

Coordinated Specialty Care (CSC)OTHER

CSC is an integrated and team-based treatment model for first episode psychosis elements include psychotherapy, supported employment and education, family education and support, and pharmacotherapy.

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

15 to 40 year olds with first episode psychosis enrolled in network CSC program

You may qualify if:

  • Enrolled in CSC program

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henderson Behavioral Health

Lauderdale Lakes, Florida, 33319, United States

RECRUITING

Central Study Contacts

Patricia Marcy, BSN

CONTACT

347-439-8035pmarcy@northwell.edu

Cristina Gonzalez, MS

CONTACT

347-804-3605

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 2, 2019

Study Start

April 1, 2020

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)