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Harlem Strong Mental Health Coalition

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MH task-sharing training
Supervision
Learning Collaborative
Technology Intervention
Sponsored by
City University of New York, School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stress-related Problem focused on measuring Task-sharing, Implementation research, Collaborative care, Behavior Activation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Harlem Congregation for Community ImprovementRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Education and Resources

Multisector Collaborative Care

Multisector Collaborative Care and Technology

Arm Description

Education 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 (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.

MCC sites will be randomized to receive an additional technology-based implementation tool to evaluate impact on implementation and consumer outcomes.

Outcomes

Primary Outcome Measures

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).
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).
Housing Security
% of participants who experience housing insecurity. Housing 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.
Employment Security
% of participants who experience employment insecurity. Employment insecurity is defined by meeting criteria such as currently not working, working only part-time or intermittently over the past few months, or not receiving payment for work they have performed.
Food Security
% of participants who experience food insecurity. Food insecurity is defined by meeting criteria such as not having enough to eat often or sometimes, and/or cannot afford to purchase enough food to meet their basic nutritional needs.
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.
Mental Health Service Linkage
% of successful MH linkages (connecting with MH navigator or MH referrals).

Secondary Outcome Measures

Program Adoption
% of delivering MH care components during the Supported Implementation when implementation support is provided (% of MH care components delivered - screening, assessment, education, referral).
Program Sustainment
% 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 Facilitators
The 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.
Provider Attitude towards Adopting Evidence-Based Practices (EBPAS)
The 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.
Partnerships with Coalition Members
Partnerships 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.

Full Information

First Posted
January 26, 2023
Last Updated
April 17, 2023
Sponsor
City University of New York, School of Public Health
Collaborators
Harlem Congregation for Community Improvement, Inc., Healthfirst
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1. Study Identification

Unique Protocol Identification Number
NCT05833555
Brief Title
Harlem Strong Mental Health Coalition
Official Title
Harlem Strong Mental Health Coalition: A Multi-sector Community-Engaged Collaborative for System Transformation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City University of New York, School of Public Health
Collaborators
Harlem Congregation for Community Improvement, Inc., Healthfirst

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress-related Problem, Depression, Anxiety, Mental Health Wellness
Keywords
Task-sharing, Implementation research, Collaborative care, Behavior Activation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education and Resources
Arm Type
Active Comparator
Arm Description
Education 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.
Arm Title
Multisector Collaborative Care
Arm Type
Experimental
Arm Description
Multisector 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.
Arm Title
Multisector Collaborative Care and Technology
Arm Type
Experimental
Arm Description
MCC sites will be randomized to receive an additional technology-based implementation tool to evaluate impact on implementation and consumer outcomes.
Intervention Type
Behavioral
Intervention Name(s)
MH task-sharing training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Supervision
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Learning Collaborative
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Technology Intervention
Intervention Description
To be determined by community crowdsourcing after the first phase of implementation of the multisector collaborative care for MH task-sharing.
Primary Outcome Measure Information:
Title
Depression - PHQ-9
Description
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).
Time Frame
6-12 months
Title
Anxiety - GAD-7
Description
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).
Time Frame
6-12 months
Title
Housing Security
Description
% of participants who experience housing insecurity. Housing 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.
Time Frame
6-12 months
Title
Employment Security
Description
% of participants who experience employment insecurity. Employment insecurity is defined by meeting criteria such as currently not working, working only part-time or intermittently over the past few months, or not receiving payment for work they have performed.
Time Frame
6-12 months
Title
Food Security
Description
% of participants who experience food insecurity. Food insecurity is defined by meeting criteria such as not having enough to eat often or sometimes, and/or cannot afford to purchase enough food to meet their basic nutritional needs.
Time Frame
6-12 months
Title
Reach of Screening
Description
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.
Time Frame
0-24 months
Title
Mental Health Service Linkage
Description
% of successful MH linkages (connecting with MH navigator or MH referrals).
Time Frame
0-24 months
Secondary Outcome Measure Information:
Title
Program Adoption
Description
% of delivering MH care components during the Supported Implementation when implementation support is provided (% of MH care components delivered - screening, assessment, education, referral).
Time Frame
0-12 months
Title
Program Sustainment
Description
% 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).
Time Frame
24 months
Title
Implementation Barriers and Facilitators
Description
The 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.
Time Frame
12, 24 months
Title
Provider Attitude towards Adopting Evidence-Based Practices (EBPAS)
Description
The 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.
Time Frame
0, 6, 12, 24 months
Title
Partnerships with Coalition Members
Description
Partnerships 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.
Time Frame
0, 6, 12, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thinh Vu, MSc
Phone
646-309-7981
Email
thinh.vu@sph.cuny.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Levine, LCSW
Phone
917-549-6155
Email
Deborah.levine@cuny.sph.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Ngo, PhD
Organizational Affiliation
CUNY Graduate School of Public Health and Health Policy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harlem Congregation for Community Improvement
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malcolm Punter, Ed.D
Phone
212-281-4887
Ext
205
Email
mpunter@hcci.org
First Name & Middle Initial & Last Name & Degree
Malcolm Punter, Ed.D

12. IPD Sharing Statement

Learn more about this trial

Harlem Strong Mental Health Coalition

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