Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05092542 |
| Other study ID # |
07521 |
| Secondary ID |
R01MH127733 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 18, 2021 |
| Est. completion date |
July 31, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
University of New Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study tests the effectiveness of a community-based peer advocacy, mutual learning, and
social support intervention (Refugee and Immigrant Well-being Project) to reduce several
negative consequences of the COVID-19 pandemic that are disproportionately impacting Latinx
and Black populations: psychological distress, financial problems, and daily stressors. In
partnership with five community-based organizations that focus on mental health, legal,
education, and youth issues with Latinx immigrants and African refugees, we will also be able
to examine the effects of people's involvement with community-based organizations and local
and state policy changes on their mental health, economic stability, stressors, and social
support. This is important not only for Latinx and Black populations and the large number of
immigrants and refugees in the United States and worldwide, but also because the intervention
model and what we learn from this study have the potential to alleviate mental health
disparities experienced by other marginalized populations who face unequal access to social
and material resources, disproportionate exposure to trauma and stress, and worse
consequences of the COVID-19 pandemic.
Description:
The goal of this study is to test a multilevel approach to reduce adverse consequences of the
COVID-19 pandemic with disparate impacts on Latinx and Black immigrants and refugees by
observing and implementing three nested levels of intervention: 1) an efficacious 6-month
peer advocacy and mutual learning model (Refugee and Immigrant Well-being Project, RIWP); 2)
engagement with community-based organizations (CBOs); and 3) structural policy changes
expected to be enacted in response to the pandemic, such as a state disaster relief proposal
for mixed status Latinx families and expanded statewide health insurance coverage. This
community-based participatory research (CBPR) study builds on a long-standing collaboration
with five community-based organizations (CBOs) that focus on mental health, education, legal
issues, and system change efforts to improve the well-being of Latinx immigrants and African
refugees. By including 240 Latinx immigrants and 60 African refugees recruited from CBO
partners who are randomly assigned to treatment-as-usual CBO involvement or the RIWP
intervention and a random sample comparison group of 900 Latinx immigrants, this mixed
methods longitudinal waitlist control group design study with five time points over 28 months
will test the effectiveness of the RIWP intervention and engagement with CBOs to reduce
psychological distress, daily stressors, and economic precarity and increase protective
factors (social support, critical awareness of/access to resources, English proficiency,
cultural connectedness, and mental health service use). This study will also test the ability
of the RIWP intervention and engagement with CBOs to increase access to the direct benefits
of structural interventions (local/state relief-related policies) for Latinx and Black
immigrants and refugees. Mechanisms of intervention effectiveness will be explored by testing
mediating relationships between primary outcomes and protective factors. Investigators will
also track local/state policy changes and obtain preliminary quantitative estimates of
effects of these structural interventions on psychological distress, stressors, and economic
precarity using propensity score matching. Qualitative interview data from a purposive
subsample of participants and CBO staff will enable additional exploration of mechanisms of
change, the effects of policy interventions on individuals, how CBOs contribute to enacting
policies and helping people benefit from them, and the context of RIWP implementation at each
site. This research is innovative and significant because it employs cutting-edge research
design and intervention strategies to advance the science of multilevel mental health
interventions that aim to understand and address underlying structural inequities and
resulting mental health disparities that have been highlighted and exacerbated by the
pandemic. Thus, this study will contribute not only to reducing the disparate adverse mental
health, behavioral, and socioeconomic consequences of the COVID-19 pandemic but also to
eliminating mental health disparities among Latinx and Black populations.
