Actively Recruiting

Phase 4
Age: 15Years - 40Years
All Genders
Healthy Volunteers
ID04005378

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

Led by Northwell Health · Updated on 2024-09-19

300

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

N

Northwell Health

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying patients experiencing their first episode of psychosis who are receiving coordinated specialty care (CSC). The study aims to identify those at high risk of disengaging from treatment and to test ways to prevent or delay this from happening. Maintaining engagement is important for patients to benefit fully from CSC, and this research focuses on improving that outcome. The study has two phases. In Phase 1, researchers will confirm a model that predicts which patients might later disengage from care. In Phase 2, participants identified as high risk will be randomly assigned to receive either a special Step-down intervention using web-based telemedicine and a smartphone app or the usual care provided by the CSC center. This intervention is designed to reduce the chance of disengagement. Participants will be monitored to see how often they stay engaged in care over at least six months. Researchers will measure the rate of disengagement between the two groups. The study will include assessments through telemedicine and app use, with ongoing follow-up to evaluate the effectiveness of the intervention in keeping patients connected with their care team. The total participation duration varies based on individual involvement in the study phases.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 15Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Enrolled into a CSC program
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - At least 6 months

Participants receive either the CSC Step-down intervention involving web-based telemedicine and a smartphone app, or usual care provided by the CSC center to reduce disengagement likelihood.

Regular contacts via telemedicine or in-person visits depending on assigned group

Trial Site Locations

Total: 3 locations

1

Henderson Behavioral Health

Lauderdale Lakes, Florida, United States, 33319

Actively Recruiting

2

InterAct of Michigan

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

3

InterAct of Michigan

Kalamazoo, Michigan, United States, 49007

Actively Recruiting

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Research Team

P

Patricia Marcy, BSN

C

Cristina Gonzalez, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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