Clinical trial NCT06771167: Building Community Resilience Program
Official title: NYC Community Engagement Alliance (NYCEAL) Against COVID-19 Disparities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Resilience, Psychological
Burnout, Psychological
Stress, Psychological
Keywords: Resilience
Community Health Workers
Burnout
Emotional Well-Being
Educational Workshops
Community-Based Organizations
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The researchers will employ a quasi-experimental 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.
Primary purpose: PREVENTION

Brief summary: Established in 2021, NYCEAL consists of approximately 40 organizational partners and 120 Community Health Workers (CHWs). Over the next four years (2024-2028), NYCEAL will work with this network to implement the following intervention: Building Community Resilience Program (BCR). To assess the impact of this intervention, an implementation research framework will be used, and pre- and post-surveys conducted, and other process evaluation measures collected. Changes in outcomes measures such as stress, resilience, overall wellbeing, and other related outcomes for participants in the BCR program will be measured for community healthcare workers and/or frontline workers that receive educational workshops.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mini-Z Burnout Scale Score
timeFrame: Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
Secondary outcomes:
measure: The Mount Sinai Resilience Scale Scores
timeFrame: Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
measure: NIOSH Worker Well-being Questionnaire - Stress
timeFrame: Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
measure: NIOSH Worker Well-being Questionnaire - Collegial Support
timeFrame: Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
measure: NIOSH Worker Well-being Questionnaire - Meaningful Work
timeFrame: Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
measure: NIOSH Worker Well-being Questionnaire - Fair/Equitable Compensation
timeFrame: Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
measure: NIOSH Worker Well-being Questionnaire - Job Security
timeFrame: Baseline (within one month before workshops begin) and post-test (within one month after workshops end at 6 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Carol Horowitz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: