Recruiting

Engagement Navigator

Sponsor:

University of Maryland, Baltimore

Code:

NCT06583239

Conditions

Disengagement

Eligibility Criteria

Sex: All

Age: 13 - 35

Healthy Volunteers: Not accepted

Interventions

Engagement Navigator Service (ENS)

Study Details

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

Study ID

NCT06583239

Start date

Feb 2, 2026

Status verified date

May, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 35

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Do not meet inclusion criteria

Study Design

Enrollment

555 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Engagement Navigator Service (ENS)

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.

no intervention: No ENS

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

Interventions

Engagement Navigator Service (ENS)

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.

Primary outcome measure

  • Rate of discharge [ Time Frame: From enrollment to end of treatment at 2 years ]
  • Time in treatment [ Time Frame: From enrollment to end of treatment at 2 years ]

Central Contacts and Locations

Central contacts

Melanie Bennett

4107060892mbennett@som.umaryland.edu

Brian Brandler

bbrandler@som.umaryland.edu

Locations

University of Maryland Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Melanie Bennett

410-706-0892mbennett@som.umaryland.edu

Brian Brandler

bbrandler@som.umaryland.edu

Principal Investigator:

Melanie Bennett

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-05-28.