Hub-Based Engagement Navigator Service to Reduce CSC Disengagement

NCT06583239 | Recruiting DMC

• 1 other identifier: 1P01MH139228
• Study Type: interventional
• Target: 555
• Locations: 1 country
• Sites: 1

Brief Summary

This project will develop a hub-based engagement navigator service for participants and families at high risk for disengagement. The investigators will use robust Participatory Research methods to ensure integration of Coordinated Specialty Care (CSC) program staff, participants, and family members in developing all aspects of and materials for the service, conduct feasibility/acceptability testing in three CSC programs, and use this information to guide refinements. This will be followed by a mixed methods hub wide evaluation using a hybrid type I open cohort stepped wedge design to examine feasibility, acceptability, and effectiveness to improve disengagement outcomes and address target mechanisms.

Conditions

Disengagement

Keywords

first episode psychosis; Coordinated Specialty Care; treatment disengagement; mental health services

Outcome Measures

Primary Outcomes (2)

• Rate of discharge

  The investigators will compare rate of disengagement for CSC participants with ENS access to those in usual care who do not have ENS access.

  From enrollment to end of treatment at 2 years

• Time in treatment

  The investigators will compare time in treatment for participants with ENS access to that of participants in usual care who do not have ENS access.

  From enrollment to end of treatment at 2 years

Study Arms (2)

Engagement Navigator Service (ENS)

EXPERIMENTAL

ENS will be a centralized service, staffed by dedicated professional to (1) receive and organize referrals, (2) complete ongoing specialized training in engagement science and evidence-based strategies, (3) provide unbiased support when participants' and/or families' relationships with a CSC program are poor, (4) re-engage participants in CSC or actively connect them with other services if preferred, and (5) continue contact with those who refuse treatment in case they reconsider.

Other: Engagement Navigator Service (ENS)

No ENS

NO INTERVENTION

Those who do not participate in ENS will comprise the no intervention arm.

Interventions

Engagement Navigator Service (ENS) OTHER

ENS will be a centralized service, staffed by dedicated professional to (1) receive and organize referrals, (2) complete ongoing specialized training in engagement science and evidence-based strategies, (3) provide unbiased support when participants' and/or families' relationships with a CSC program are poor, (4) re-engage participants in CSC or actively connect them with other services if preferred, and (5) continue contact with those who refuse treatment in case they reconsider.

Engagement Navigator Service (ENS)

Eligibility Criteria

• Age: 13 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients receiving services at Coordinated Specialty Care programs for the treatment of early episode psychosis
• Age 13-35

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

Central Study Contacts

Melanie Bennett

CONTACT

4107060892; mbennett@som.umaryland.edu

Brian Brandler

CONTACT

bbrandler@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: September 3, 2024
• Study Start: February 2, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)