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Clinical Trials/NCT05833555
NCT05833555
Recruiting
Not Applicable

Harlem Strong Mental Health Coalition: A Multi-sector Community-Engaged Collaborative for System Transformation

City University of New York, School of Public Health2 sites in 1 country700 target enrollmentApril 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress-related Problem
Sponsor
City University of New York, School of Public Health
Enrollment
700
Locations
2
Primary Endpoint
Depression - PHQ-9
Status
Recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 5, 2023
End Date
August 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
City University of New York, School of Public Health
Responsible Party
Principal Investigator
Principal Investigator

Victoria Ngo

Associate Professor

City University of New York, School of Public Health

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

Outcomes

Primary Outcomes

Depression - PHQ-9

Time Frame: 6-12 months

Depression symptom severity is assessed using the Patient Health Questionnaire (PHQ-9), which includes nine items on a scale ranging from "0" (Not at all) to "3" (Nearly every day). PHQ-9 scores range from 0 to 27, with higher scores indicating greater severity of depression. The scores are categorized into five levels: minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).

Reach of Screening

Time Frame: 0-24 months

Number of new consumers screened for depression using the Patient Health Questionnaire (PHQ-4) relative to the total number of low-income housing residents or patients seen at the sites will be used.

Anxiety - GAD-7

Time Frame: 6-12 months

Anxiety symptom severity is assessed using the General Anxiety Disorder (GAD-7) scale, which consists of seven items designed to screen and evaluate anxiety symptom severity on a scale ranging from "0" (Not at all) to "3" (Nearly every day). GAD-7 scores range from 0 to 21, with higher scores indicating greater anxiety symptoms. Scores are classified into four levels: minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21).

Mental Health Service Linkage

Time Frame: 0-24 months

% of successful MH linkages (connecting with MH navigator or MH referrals).

Secondary Outcomes

  • Employment Security(6-12 months)
  • Program Sustainment(24 months)
  • Implementation Barriers and Facilitators(12, 24 months)
  • Food Insecurity(6-12 months)
  • Program Adoption(0-12 months)
  • Provider Attitude towards Adopting Evidence-Based Practices (EBPAS)(0, 6, 12, 24 months)
  • Partnerships with Coalition Members(0, 6, 12, 24 months)
  • Housing Security(6-12 months)

Study Sites (2)

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