NCT04005378

Brief Summary

Maintaining treatment engagement is critical for first episode psychosis patients to experience gains possible with coordinated specialty care (CSC). This study is designed to identify CSC participants still receiving care but at high risk for disengagement and to intervene to prevent/delay disengagement.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2020

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

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

July 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4.4 years

First QC Date

July 1, 2019

Last Update Submit

September 10, 2024

Conditions

First Episode Psychosis

Outcome Measures

Primary Outcomes (1)

  • Disengagement rate

    Rate of disengagement from CSC program

    Minimum of 6 months

Study Arms (2)

CSC Step-down intervention

OTHER

Web-based telemedicine and a smartphone app, to decrease disengagement likelihood

Other: CSC Step-down intervention

Usual Care

OTHER

Usual care provided by CSC center

Other: Usual Care

Interventions

CSC Step-down interventionOTHER

Web-based telemedicine and a smartphone app, to decrease disengagement likelihood

CSC Step-down intervention
Usual CareOTHER

Usual Care provided by CSC center

Usual Care

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Enrolled into a CSC program

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Henderson Behavioral Health

Lauderdale Lakes, Florida, 33319, United States

RECRUITING

InterAct of Michigan

Grand Rapids, Michigan, 49503, United States

RECRUITING

InterAct of Michigan

Kalamazoo, Michigan, 49007, 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
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Assigned to either treatment as usual or to the disengagement treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 2, 2019

Study Start

July 1, 2020

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(3)