Hub-Based Engagement Navigator Service to Reduce CSC Disengagement

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06583239
Status
Recruiting

Conditions

  • Disengagement

Eligibility Criteria

Sex
ALL
Age
13 Years - 35 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Feb 2, 2026
Status verified
May 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
555 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland BaltimoreBaltimoreMaryland21201
Melanie Bennett
410-706-0892
Brian Brandler
Melanie Bennett (PRINCIPAL_INVESTIGATOR)

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