Clinical trial NCT05833555: Harlem Strong Mental Health Coalition
Official title: Harlem Strong Mental Health Coalition: A Multi-sector Community-Engaged Collaborative for System Transformation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress-related Problem
Depression, Anxiety
Mental Health Wellness
Keywords: Task-sharing
Implementation research
Collaborative care
Behavior Activation
Lead sponsor: City University of New York, School of Public Health
Sponsor class: OTHER
Collaborators: name: Harlem Congregation for Community Improvement, Inc.
name: Healthfirst
First posted: 2023-04-27
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Addressing health disparities, especially in the face of coronavirus pandemic, requires an integrated multi-sector equity-focused, community-based approach. This study will examine the impact of Harlem Strong Community Mental Health Collaborative, a community-wide multi-sectoral coalition in which a health insurer works with a network of community-based organizations, medical providers, and behavioral health providers to engage in a network-wide implementation planning process to: (1) problem-solve financing, access, and quality of care barriers, (2) support capacity building for mental health (MH) task-sharing for community health workers, (3) facilitate coordination and collaboration across MH/behavioral health, primary care, and a range of social services, including case management, housing supports, financial education, employment support, and other community resources to improve linkages to services, and (4) identify a set of common MH, social risk, and health metrics and strategies to integrate these metrics into data systems across the network for continuous quality improvement of the system. The long-term goal of our study is to develop sustainable model for task-sharing MH care that will be embedded in a coordinated comprehensive network of services, including primary care, behavioral/MH, social services, and other community resources.

Detailed description: This study examines the impact of Harlem Strong Community Mental Health Collaborative, a community-wide multi-sectoral coalition in which a health insurer works with community-based organizations and medical and behavioral health providers to (1) problem-solve financing, access, and quality of care barriers, (2) support capacity building for MH task-sharing for community health workers, (3) facilitate coordination and collaboration across MH/behavioral health, primary care, and social services, and (4) identify a set of common metrics and strategies for continuous system quality improvement. The research study will evaluate the impact using a Hybrid Implementation-Effectiveness design to assess the effects of the Harlem Strong Collaborative on implementation and consumer outcomes. The investigators will also describe implementation outcomes and key informant interviews to explore impact of community engagement, organization variables, and provider factors on model impact. The long-term goal of this study is to develop a sustainable model for task-sharing MH care that will be embedded in a coordinated comprehensive network of services.

The investigators will conduct a stepped-wedge clustered randomized control study evaluating the effectiveness of a MH task-sharing intervention, that involves randomization and sequenced exposure to three implementation conditions: (1) online education and resources (E\&R) about MH task-sharing (screening, education, and referral), (2) community-engaged multisector collaborative care model (MCC), where a neighborhood-based coalition will support implementation of MH task-sharing, and (3) community crowdsourced technology solution to support implementation (MCC+Tech).

Eligibility criteria: Inclusion Criteria:

* Black and Latino adults between 18 and 65 years
* Harlem residents from low-income housing developments or receiving primary care services in Harlem
* PHQ-4 Total Score ≥3, moderate risk for depression

Exclusion Criteria:

* Those with risk for depression or anxiety who screen positive for severe mental illness (e.g., psychosis, mania, substance abuse, and high suicide risk) using screening items from the Mini-International Neuropsychiatric Interview will be excluded from the study and referred to MH services at higher levels of care

Primary outcomes:
measure: Depression - PHQ-9
timeFrame: 6-12 months
measure: Anxiety - GAD-7
timeFrame: 6-12 months
measure: Reach of Screening
timeFrame: 0-24 months
measure: Mental Health Service Linkage
timeFrame: 0-24 months
Secondary outcomes:
measure: Program Adoption
timeFrame: 0-12 months
measure: Program Sustainment
timeFrame: 24 months
measure: Implementation Barriers and Facilitators
timeFrame: 12, 24 months
measure: Provider Attitude towards Adopting Evidence-Based Practices (EBPAS)
timeFrame: 0, 6, 12, 24 months
measure: Partnerships with Coalition Members
timeFrame: 0, 6, 12, 24 months
measure: Housing Security
timeFrame: 6-12 months
measure: Employment Security
timeFrame: 6-12 months
measure: Food Insecurity
timeFrame: 6-12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: CUNY Graduate School of Public Health and Health Policy
state: New York
city: New York
country: United States
facility: Harlem Congregation for Community Improvement
state: New York
Study officials:
affiliation: City University of New York
name: Victoria K Ngo, PhD
role: PRINCIPAL_INVESTIGATOR
References: