- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06771167
Building Community Resilience Program (BCR)
NYC Community Engagement Alliance (NYCEAL) Against COVID-19 Disparities
Study Overview
Status
Intervention / Treatment
Detailed Description
BCR Study Design and Methods: To incorporate adequacy and plausibility, approaches in public health research often move beyond randomized trials to better support evaluation and public health decision-making, while being responsive to the three hallmarks of sound study design: minimizing selection and information bias, controlling confounding, and ruling out chance. BCR will leverage a quasi-experimental approach to evaluate the impact of the proposed intervention on participating NYCEAL CBOs' CHWs. The researchers will employ a pre-post non-equivalent waitlist control group design to proactively minimize logistical barriers, maximize feasibility of implementing the intervention, and reduce ethical concerns of depriving communities of beneficial interventions. The waitlist control sites (the second cohort of CBOs receiving the educational workshops) are expected to have similar sociodemographic characteristics and health burdens as the intervention sites. Data collection in the second cohort of sites will allow the researchers to examine whether observed changes in outcomes are attributable to the intervention and ensure that all of the partnering CBO sites have access to BCR educational workshops for CHWs and frontline workers. The researchers will assess impact using an outcomes survey co-developed with NYCEAL CBO partners (not individuals receiving the intervention). The researchers will conduct surveys via RedCap at pre- and 6-month post-intervention timepoints with CHWs at BCR sites (for both cohorts). The primary outcome for the CHW intervention is burnout (Mini-Z burnout scale), which is closely linked to workforce retention, work quality, and client interactions. Secondary outcomes include validated measures for resilience, stress, worker wellbeing, and job satisfaction. BCR intervention sites were chosen based on interest, history of collaboration, readiness, capacity and interest in promoting resilience, and consequently overall good health at the organizational level, and as they serve priority populations in high disparity neighborhoods (and the wellbeing of these sites is important for continuing the work of supporting local communities).
The BCR educational workshops will take place over two years, with two cohorts of six CBOs each (12 CBOs total). Both cohorts will be recruited simultaneously, with the second cohort serving as a waitlist control group during the first year. To improve CHW resilience and wellbeing, during each BCR cycle, the 6 participating CBOs will send groups of four to six CHWs to participate in the program (48-72 CHWs over the 2 cycles). Each cohort will receive six virtual, hour-long, evidence-based interactive workshops, delivered once per month over a six-month period. The first cohort will receive the intervention in year 1, while the second cohort will receive the intervention in year 2.
Topics include: 1) realistic optimism ("Build Your Hope"); 2) active coping and facing fears ("Face Your Fears"); 3) self-care ("Mind Your Body"); 4) social support and networks ("Mind Your Circle"); 5) building our "why" ("Mind Your Purpose"); and 6) addressing social justice ("Mind Your Community"). DePierro and an experienced social worker will co-facilitate the interactive, skills based workshops. They will include information in lay format about the importance of resilience factors and activities that result in the development of resilience plans. For example, activities to support the development of "utilizing social support networks"include building/mapping a social support network tree that allows people to take stock of the areas of support needed to further cultivate, and develop action-oriented SMART goals that address specific needs. Workshop participants will also have free access to a mobile app (Wellness Hub) that was developed by DePierro they can use to reinforce these topics through maintenance activities.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Devin Madden, PhD, MPH
- Phone Number: 212-659-9552
- Email: devin.madden@mountsinai.org
Study Contact Backup
- Name: Nita Vangeepuram, MD, MPH
- Email: nita.vangeepuram@mssm.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Recruiting
- Icahn School of Medicine at Mount Sinai
-
Contact:
- Devin Madden, MPH, PhD
- Phone Number: 212-659-9552
- Email: devin.madden@mountsinai.org
-
Contact:
- Rachel Reich, BA
- Email: rachel.reich@mountsinai.org
-
Principal Investigator:
- Carol Horowitz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able to consent
- Able to fill out the screening RedCap short survey
- Have access to a computer or smart gadget that will allow participant to be able to join the zoom call
- English speaking
- Living in NYC (5 boroughs)
- 18+ years of age (no upper bound age limit)
- Working with an NYCEAL CBO participating in BCR programming
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Incapacitated to an extent that they are unable to comprehend a conversation or communicate effectively in a group setting
- Unable to consent to be part of the study
- Does not have access to a computer or smart gadget that will allow participant to be able to join the zoom call
- Does not speak English
- Not living in NYC
- Not 18+ years of age
- Not working with an NYCEAL CBO participating in BCR programming
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Intervention Group (First Cohort)
The first cohort of up to 36 participants will complete two surveys: a baseline survey within one month before the workshops begin, and a post-test survey within one month after the final workshop (approximately 8 months total from first to last survey)
|
To improve CHW resilience and wellbeing, during each BCR cycle, the 6 participating CBOs will send groups of four to six CHWs to six virtual, hour-long, evidence-based interactive workshops (48-72 CHWs over the 2 cycles).
|
|
Experimental: Waitlist Group (Second Cohort)
The second cohort of up to 36 participants will complete four surveys: two surveys in year 1 (matching the timing of the first cohort's surveys to serve as a control group), and two additional surveys in year 2 when they receive the intervention (a baseline survey within one month before their workshops begin, and a post-test survey within one month after their final workshop).
|
To improve CHW resilience and wellbeing, during each BCR cycle, the 6 participating CBOs will send groups of four to six CHWs to six virtual, hour-long, evidence-based interactive workshops (48-72 CHWs over the 2 cycles).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini-Z Burnout Scale Score
Time Frame: Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
|
The Mini Z Burnout Inventory score measures burnout and is calculated by summing responses from all 10 questions, with possible scores ranging from 10 to 50.
Higher scores indicate a more positive and joyful work environment, with scores of 40 or above representing a joyful workplace.
|
Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Mount Sinai Resilience Scale Scores
Time Frame: Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
|
The Mount Sinai Resilience Scale (MSRS) measures resilience with scores ranging from 0 to 144.
Scores of 45 or higher may indicate average or above-average resilience levels.
Higher scores indicate higher level of resilience.
|
Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
|
|
NIOSH Worker Well-being Questionnaire - Stress
Time Frame: Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
|
The stress measure consists of 4 selected items from the NIOSH Worker Well-being Questionnaire (WellBQ).
The overall stress score is calculated as the average of these 4 items, with scores above the midpoint indicating high stress levels.
Responses are indicated on a 7-item Likert scale from.
Full scale from 1-7.
Higher scores indicate stronger feelings of collegial support.
|
Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
|
|
NIOSH Worker Well-being Questionnaire - Collegial Support
Time Frame: Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
|
Collegial Support is measured using 9 items from the NIOSH Worker Well-being Questionnaire (WellBQ).
Responses are indicated on a 5 point Likert scale with '1' being "Strongly Disagree", '4' being "Strongly Agree", and '5' being "Does not apply".
Full scale from 1-5.
Higher scores indicate stronger feelings of collegial support.
|
Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
|
|
NIOSH Worker Well-being Questionnaire - Meaningful Work
Time Frame: Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
|
Meaningful work is measured using 2 selected items from the NIOSH Worker Well-being Questionnaire (WellBQ).
Responses are indicated on a 5 point Likert scale with '1' being "Strongly Disagree", '4' being "Strongly Agree", and '5' being "Does not apply".
Full scale from 1-4.
Higher scores indicate stronger feelings of engaging in meaningful work.
|
Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
|
|
NIOSH Worker Well-being Questionnaire - Fair/Equitable Compensation
Time Frame: Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
|
Fair/equitable job compensation is measured using 1 selected items from the NIOSH Worker Well-being Questionnaire (WellBQ).
The response is indicated on a 5 point Likert scale with '1' being "Strongly Disagree", '4' being "Strongly Agree", and '5' being "Does not apply".
Higher scores indicate stronger feelings of fair compensation.
|
Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
|
|
NIOSH Worker Well-being Questionnaire - Job Security
Time Frame: Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
|
Job security is measured using 1 selected items from the NIOSH Worker Well-being Questionnaire (WellBQ).
The response is indicated on a 5 point Likert scale with '1' being "Strongly Disagree", '4' being "Strongly Agree", and '5' being "Does not apply".
Higher scores indicate stronger feelings of job security.
|
Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Carol Horowitz, MD, MPH, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 21-0396
- HL158287 (Other Grant/Funding Number: NYU's MPI NIH CEAL)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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