Harlem Strong Mental Health Coalition
1 other identifier
interventional
700
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2023
CompletedStudy Start
First participant enrolled
April 5, 2023
CompletedFirst Posted
Study publicly available on registry
April 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
August 12, 2024
August 1, 2024
3.2 years
January 26, 2023
August 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Depression - PHQ-9
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).
6-12 months
Anxiety - GAD-7
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).
6-12 months
Reach of Screening
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.
0-24 months
Mental Health Service Linkage
% of successful MH linkages (connecting with MH navigator or MH referrals).
0-24 months
Secondary Outcomes (8)
Program Adoption
0-12 months
Program Sustainment
24 months
Implementation Barriers and Facilitators
12, 24 months
Provider Attitude towards Adopting Evidence-Based Practices (EBPAS)
0, 6, 12, 24 months
Partnerships with Coalition Members
0, 6, 12, 24 months
- +3 more secondary outcomes
Study Arms (3)
Education and Resources
ACTIVE COMPARATOREducation and Resources (E\&R) involves online training through the E-Hub on delivery of basic MH task-shifting skills, such as screening, psychoeducation, and referral to MH care. A community directory along with training on community resources will be made available to all participants. Specifically, we will recommend that those identified to have common MH problems (PHQ-4≥3) are offered a single two-hour zoom-based group psychoeducation session about depression and anxiety, COVID-19 impact on MH, wellness and self-care skills, and directory of Harlem-based MH services and other community resources. Participants exhibiting higher level needs are referred to MH specialists.
Multisector Collaborative Care
EXPERIMENTALMultisector Collaborative Care (MCC) Model will consist of all resources offered in E\&R and additional trainings on skills related to working in a multisectoral team, care navigation, syndemic risks and coordination of services related to MH, social services, and health care.
Multisector Collaborative Care and Technology
EXPERIMENTALMCC sites will be randomized to receive an additional technology-based implementation tool to evaluate impact on implementation and consumer outcomes.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CUNY Graduate School of Public Health and Health Policy
New York, New York, 10025, United States
Harlem Congregation for Community Improvement
New York, New York, 10025, United States
Related Publications (1)
Ngo VK, Vu TT, Levine D, Punter MA, Beane SJ, Weiss MR, Wyka K, Florez-Arango JF, Zhou X. A multisector community-engaged collaborative for mental health integration in primary care and housing developments: Protocol for a stepped-wedge randomized controlled trial (the Harlem Strong Program). BMC Public Health. 2024 Sep 19;24(1):2554. doi: 10.1186/s12889-024-20026-6.
PMID: 39300414DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victoria K Ngo, PhD
City University of New York
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 26, 2023
First Posted
April 27, 2023
Study Start
April 5, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
August 12, 2024
Record last verified: 2024-08