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Harlem Strong Mental Health Coalition

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05833555
Enrollment
700
Registered
2023-04-27
Start date
2023-04-05
Completion date
2026-08-31
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress-related Problem, Depression, Anxiety, Mental Health Wellness

Keywords

Task-sharing, Implementation research, Collaborative care, Behavior Activation

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).

Interventions

BEHAVIORALMH task-sharing training

Providers will be trained to screen for MH, provide education, refer, and coordinate to range of social services. MH training typically consists of education and resources, such as one-time workshops and toolkits, provided with limited technical assistance.

BEHAVIORALSupervision

Additionally, Community Health Workers (CHWs) will receive bi-weekly group supervision for the first 6-months, and monthly supervision for the remaining year on Zoom from a supervisor at Center for Innovation in Mental Health.

A learning collaborative with multidisciplinary teams from various healthcare organizations will support continuous quality improvement and develop develop structured approach to improve provision of care.

To be determined by community crowdsourcing after the first phase of implementation of the multisector collaborative care for MH task-sharing.

Sponsors

Harlem Congregation for Community Improvement, Inc.
CollaboratorUNKNOWN
Healthfirst
CollaboratorOTHER
City University of New York, School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Depression - PHQ-96-12 monthsDepression 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).
Anxiety - GAD-76-12 monthsAnxiety 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).
Reach of Screening0-24 monthsNumber 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.
Mental Health Service Linkage0-24 months% of successful MH linkages (connecting with MH navigator or MH referrals).

Secondary

MeasureTime frameDescription
Partnerships with Coalition Members0, 6, 12, 24 monthsPartnerships and Collaboration are assessed using a 20-item scale developed by investigators. The scale includes different subdomains such as collaboration, organizational capacity, sustainability, and responsive models. Each item will be rated on a scale of 0 (Strongly Disagree) to 5 (Strongly Agree), with a higher score indicating greater partnership.
Housing Security6-12 monthsHousing insecurity is defined by meeting criteria such as currently living in a shelter, having experienced eviction in the past, or facing challenges in paying for their rent or mortgage.
Provider Attitude towards Adopting Evidence-Based Practices (EBPAS)0, 6, 12, 24 monthsThe Evidence-based Practice Attitude Scale with 15 items is used to assess providers' attitudes including their requirements, appeal, openness, and divergence. Each item is scored from 0 (not at all) to 4 (to a very great extent), with higher scores indicating a more positive attitude towards adopting evidence-based practices.
Food Insecurity6-12 months% of participants who experience food insecurity.
Employment Security6-12 months% of participants who experience employment insecurity.
Program Adoption0-12 months% of delivering MH care components during the Supported Implementation when implementation support is provided (% of MH care components delivered - screening, assessment, education, referral).
Program Sustainment24 months% of delivering MH care components during the Sustainment Phases when study-funded implementation supports are withdrawn (% of MH care components delivered - screening, assessment, education, referral).
Implementation Barriers and Facilitators12, 24 monthsThe investigators will review the implementation data table before conducting qualitative interviews to construct the implementation story (themes) based on the implementation data which is extracted from clinical records/logs and training records.

Countries

United States

Contacts

Primary ContactSrividhya Sharma, PhD, MPH
Srividhya.Sharma@sph.cuny.edu347-395-7943
Backup ContactDeborah Levine, LCSW
Deborah.Levine@sph.cuny.edu917-549-6155

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026