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DisengagementNCT06583239

Hub-Based Engagement Navigator Service to Reduce CSC Disengagement

A study testing Engagement Navigator Service (ENS) in people with Disengagement, run by University of Maryland, Baltimore at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 13 to 35 years
Conditions the study is for
Disengagement
What is being tested?
Engagement Navigator Service (ENS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
555 participants
Where
1 siteUnited States
Study dates
2 Feb 2026to 31 Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • Do not meet inclusion criteria

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brian Brandler contact

bbrandler@som.umaryland.edu

United States1 site, 1 recruiting
  • University of Maryland Baltimore

    Baltimore, Maryland, 21201

    Melanie Bennett, 410-706-0892, mbennett@som.umaryland.edu

    Brian Brandler, bbrandler@som.umaryland.edu

    Recruiting

Other trials in United States

About this study

Official title: Developing and Evaluating a Hub-Based Engagement Navigator Service to Reduce CSC Disengagement

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.

Read the detailed description

Coordinated Specialty Care (CSC) disengagement is alarmingly common and compromises the vision of CSC to support recovery in first episode psychosis (FEP; see Overall Section). The Early Psychosis Intervention Network's (EPINET) hub-based structure offers an opportunity to circumvent program-level implementation barriers by developing and implementing systems-level strategies to address disengagement. One strategy employs a centralized service, staffed by dedicated professionals working across a hub, 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. Currently, no hub-based strategy exists to address disengagement. The primary objective of this project is to use participatory research methods within a learning health system research framework to develop and evaluate a hub-based Engagement Navigator Service (ENS) to prevent CSC disengagement. The central hypothesis is that, once developed, ENS will support more months in treatment and lower disengagement rates than usual care (UC). The long-term goal is to co-produce a hub-based navigator service to reduce disengagement. The investigators will attain these objectives via the following specific aims:

Specific Aim 1. To develop ENS in partnership with the AC's Lived Experience and Family Member Collectives and CSC Program Implementation Subunit. Using participatory research, the investigators will specify ENS structure, training, and procedures for referrals. This aim will create the tools and resources needed to implement ENS at the hub-level.

Specific Aim 2. To conduct mixed methods feasibility/acceptability testing in three CSC programs. The investigators will track rates of and reasons for referral, length of time for navigators to contact and engage participants, and track needs that navigators address. The investigators will collect participant input via qualitative interviews. In this aim, feasibility and acceptability data and intervention experiences will be used to refine ENS.

Specific Aim 3. To conduct a mixed methods evaluation of ENS offered hub wide. Specific Aim 3a. In a hybrid type I, stepped wedge cluster randomized controlled trial, determine if access to ENS decreases disengagement compared to UC and improves target mechanisms. H1: Time in treatment for CSC participants with ENS access will be significantly longer than in UC. H2: Rate of disengagement for CSC participants with ENS access will be significantly lower than in UC. H3: Measures of autonomy, competence, and relatedness will be significantly higher for CSC participants with ENS access compared to UC. H4 (Exploratory): Autonomy, competence, and relatedness scores will mediate the treatment effect. Specific Aim 3b. Using a multi-stakeholder mixed methods process evaluation, examine feasibility, fidelity, and acceptability of ENS and identify implementation barriers and facilitators. This aim will evaluate ENS and detail experiences offering it across CLHS. This will prepare us to conduct a larger trial in the future.

Conditions
Disengagement
Being tested
Engagement Navigator Service (ENS)
Keywords
first episode psychosis, Coordinated Specialty Care, treatment disengagement, mental health services

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 groups in NCT06583239
Study groupRoleWhat they receive
Engagement Navigator Service (ENS)ExperimentalENS 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.
Receives: Other: Engagement Navigator Service (ENS)
No ENSNo interventionThose who do not participate in ENS will comprise the no intervention arm.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to end of treatment at 2 years

  2. 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.

    Measured: From enrollment to end of treatment at 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2024
  2. Study start2 Feb 2026
  3. Primary completion31 Jul 2029 (estimated)
  4. Study completion31 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
555 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06583239
Sponsor's protocol ID
1P01MH139228
Status last verified
May 2026
First submitted
1 Sep 2024
Last updated
28 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Engagement Navigator Service (ENS) in people with Disengagement, run by University of Maryland, Baltimore at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melanie Bennett (4107060892, mbennett@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of discharge (time frame: From enrollment to end of treatment at 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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