Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs

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.

Study Overview

• Status: Recruiting
• Conditions: First Episode Psychosis
• Intervention / Treatment: Other: CSC Step-down intervention; Other: Usual Care

Detailed Description

In Phase 1 of the project, we will confirm a model predicting factors associated with later disengagement from CSC treatment. In Phase 2, we will compare disengagement among high-risk individuals with a CSC Step-down intervention to that with standard CSC care. The Step-down intervention will use web-based telemedicine and a smartphone app, to decrease disengagement likelihood. High-risk participants identified by predictors found in Phase 1 will be offered the intervention.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Patricia Marcy, BSN; Phone Number: 347-439-8035; Email: pmarcy@northwell.edu
• Study Contact Backup: Name: Cristina Gonzalez, MS; Phone Number: 347-804-3605

Study Locations

• United States
  • Florida
    • Lauderdale Lakes, Florida, United States, 33319
      • Recruiting
      • Henderson Behavioral Health
      • Contact: Suzelle Guinart
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • InterAct of Michigan
      • Contact: Jacob Gonzales
    • Kalamazoo, Michigan, United States, 49007
      • Recruiting
      • InterAct of Michigan
      • Contact: Dana Schraber

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Enrolled into a CSC program

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CSC Step-down intervention; Web-based telemedicine and a smartphone app, to decrease disengagement likelihood	Other: CSC Step-down intervention; Web-based telemedicine and a smartphone app, to decrease disengagement likelihood
Other: Usual Care; Usual care provided by CSC center	Other: Usual Care; Usual Care provided by CSC center

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disengagement rate	Rate of disengagement from CSC program	Minimum of 6 months

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Estimated): April 15, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders
• Other Study ID Numbers: 19-0307 -B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No