Hub-Based Engagement Navigator Service to Reduce CSC Disengagement
NCT ID: NCT06583239
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
555 participants
INTERVENTIONAL
2026-06-01
2029-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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 ENS
Those who do not participate in ENS will comprise the no intervention arm.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 13-35
13 Years
35 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Maryland, Baltimore
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Melanie E Bennett
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Maryland Baltimore
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Melanie Bennett
Role: primary
Brian Brandler
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.