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

Primary Purpose

First Episode Psychosis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CSC Step-down intervention
Usual Care
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for First Episode Psychosis

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Enrolled into a CSC program

Exclusion Criteria:

  • None

Sites / Locations

  • Henderson Behavioral HealthRecruiting
  • InterAct of MichiganRecruiting
  • InterAct of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

CSC Step-down intervention

Usual Care

Arm Description

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

Usual care provided by CSC center

Outcomes

Primary Outcome Measures

Disengagement rate
Rate of disengagement from CSC program

Secondary Outcome Measures

Full Information

First Posted
July 1, 2019
Last Updated
September 28, 2023
Sponsor
Northwell Health
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04005378
Brief Title
Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs
Official Title
Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First Episode Psychosis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Assigned to either treatment as usual or to the disengagement treatment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CSC Step-down intervention
Arm Type
Other
Arm Description
Web-based telemedicine and a smartphone app, to decrease disengagement likelihood
Arm Title
Usual Care
Arm Type
Other
Arm Description
Usual care provided by CSC center
Intervention Type
Other
Intervention Name(s)
CSC Step-down intervention
Intervention Description
Web-based telemedicine and a smartphone app, to decrease disengagement likelihood
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual Care provided by CSC center
Primary Outcome Measure Information:
Title
Disengagement rate
Description
Rate of disengagement from CSC program
Time Frame
Minimum of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Enrolled into a CSC program Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Marcy, BSN
Phone
347-439-8035
Email
pmarcy@northwell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Gonzalez, MS
Phone
347-804-3605
Facility Information:
Facility Name
Henderson Behavioral Health
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzelle Guinart
Facility Name
InterAct of Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Gonzales
Facility Name
InterAct of Michigan
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Schraber

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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