Stress-related ProblemNCT05833555
Harlem Strong Mental Health Coalition
A study testing MH task-sharing training, Supervision and Learning Collaborative in people with Stress-related Problem and Depression, Anxiety, run by City University of New York, School of Public Health at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress-related Problem, Depression, Anxiety, Mental Health Wellness
- What is being tested?
- MH task-sharing training, Supervision and Learning Collaborative
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Apr 2023to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
CUNY Graduate School of Public Health and Health Policy
New York, New York, 10025
Victoria K Ngo, PhD, 626-780-7899, victoria.ngo@sph.cuny.edu
- Recruiting
Harlem Congregation for Community Improvement
New York, New York, 10025
Malcolm Punter, Ed.D, 212-281-4887 ext. 205, mpunter@hcci.org
Malcolm Punter, Ed.D
About this study
Official title: Harlem Strong Mental Health Coalition: A Multi-sector Community-Engaged Collaborative for System Transformation
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.
Read the 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).
- Being tested
- MH task-sharing training, Supervision, Learning Collaborative, Technology Intervention
- Keywords
- Task-sharing, Implementation research, Collaborative care, Behavior Activation
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MH task-sharing trainingBehavioural
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.
SupervisionBehavioural
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.
Learning CollaborativeBehavioural
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.
Technology InterventionOther
To be determined by community crowdsourcing after the first phase of implementation of the multisector collaborative care for MH task-sharing.
| Study group | Role | What they receive |
|---|---|---|
| Education and Resources | Active comparator | 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. Receives: Behavioral: MH task-sharing training |
| Multisector Collaborative Care | Experimental | 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. Receives: Behavioral: MH task-sharing training; Behavioral: Supervision; Behavioral: Learning Collaborative |
| Multisector Collaborative Care and Technology | Experimental | MCC sites will be randomized to receive an additional technology-based implementation tool to evaluate impact on implementation and consumer outcomes. Receives: Behavioral: MH task-sharing training; Behavioral: Supervision; Behavioral: Learning Collaborative; Other: Technology Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 0-24 months
Mental Health Service Linkage
% of successful MH linkages (connecting with MH navigator or MH referrals).
Measured: 0-24 months
Secondary outcomes (8)
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).
Measured: 0-12 months
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).
Measured: 24 months
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.
Measured: 12, 24 months
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.
Measured: 0, 6, 12, 24 months
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.
Measured: 0, 6, 12, 24 months
Housing Security
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.
Measured: 6-12 months
Employment Security
% of participants who experience employment insecurity.
Measured: 6-12 months
Food Insecurity
% of participants who experience food insecurity.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start5 Apr 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress-related ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City University of New York, School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Harlem Congregation for Community Improvement, Inc., Healthfirst
- Responsible party
- Principal investigator, Victoria Ngo, City University of New York, School of Public Health
- Investigators
- Victoria K Ngo, PhD, Principal investigator, City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833555
- Sponsor's protocol ID
- U01OD033245
- Status last verified
- May 2026
- First submitted
- 26 Jan 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39300414
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harlem Strong Mental Health Coalition: A Multi-sector Community-Engaged Collaborative for System Transformation
- ClinicalTrials.gov ID
- NCT05833555
- Acronym / sponsor ID
- U01OD033245
- Keywords
- Task-sharing, Implementation research, Collaborative care, Behavior Activation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- City University of New York, School of Public HealthUniversity, hospital or other
- Collaborators
- Harlem Congregation for Community Improvement, Inc., Healthfirst
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education and Resources | Active comparator | Behavioral: MH task-sharing trainingEducation 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 | Experimental | Behavioral: MH task-sharing training, Behavioral: Supervision, Behavioral: Learning CollaborativeMultisector 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 | Experimental | Behavioral: MH task-sharing training, Behavioral: Supervision, Behavioral: Learning Collaborative, Other: Technology InterventionMCC sites will be randomized to receive an additional technology-based implementation tool to evaluate impact on implementation and consumer outcomes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MH task-sharing trainingProviders 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. | Behavioural | Education and Resources, Multisector Collaborative Care, Multisector Collaborative Care and Technology |
| SupervisionAdditionally, 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. | Behavioural | Multisector Collaborative Care, Multisector Collaborative Care and Technology |
| Learning CollaborativeA learning collaborative with multidisciplinary teams from various healthcare organizations will support continuous quality improvement and develop develop structured approach to improve provision of care. | Behavioural | Multisector Collaborative Care, Multisector Collaborative Care and Technology |
| Technology InterventionTo be determined by community crowdsourcing after the first phase of implementation of the multisector collaborative care for MH task-sharing. | Other | Multisector Collaborative Care and Technology |
Primary outcome
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).
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).
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.
Mental Health Service Linkage
Time frame: 0-24 months
% of successful MH linkages (connecting with MH navigator or MH referrals).
8 secondary outcomes
Program Adoption
Time frame: 0-12 months
Program Sustainment
Time frame: 24 months
Implementation Barriers and Facilitators
Time frame: 12, 24 months
Provider Attitude towards Adopting Evidence-Based Practices (EBPAS)
Time frame: 0, 6, 12, 24 months
Partnerships with Coalition Members
Time frame: 0, 6, 12, 24 months
Housing Security
Time frame: 6-12 months
Employment Security
Time frame: 6-12 months
Food Insecurity
Time frame: 6-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Derived from this study: PubMed 39300414Ngo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victoria K Ngo, PhD principal investigator
City University of New York
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MH task-sharing training, Supervision and Learning Collaborative in people with Stress-related Problem and Depression, Anxiety, run by City University of New York, School of Public Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Srividhya Sharma, PhD, MPH (347-395-7943, Srividhya.Sharma@sph.cuny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression - PHQ-9 (time frame: 6-12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05833555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.