Clinical trial NCT05092542: Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Official title: Multilevel Community-Based Mental Health Intervention to Address Structural Inequities and Adverse Disparate Consequences of COVID-19 Pandemic on Latinx Immigrant and African Refugees
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Issue
Mental Health Disorder
Stress, Emotional
Economic Problems
Keywords: Latinx immigrant
African refugee
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-10-25
Enrollment: 1212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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).
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* All Latinx immigrants and African refugees aged 18 and older residing in New Mexico will be eligible to participate.

Exclusion Criteria:

* For the random sample of 1000 Latinx immigrants, exclusion criteria will be having used the services of one of the four community-based partner organizations serving Latinx immigrants within the past year (at time of study enrollment). For the 240 Latinx immigrants and 60 African refugees recruited through the five community-based organizations, exclusion criteria will be severe cognitive functioning problems or mental illness that is so severe as to impede participation in a group and that warrants immediate individual treatment.

Primary outcomes:
measure: Psychological Distress
timeFrame: All 7 timepoints over 36 months
measure: Psychological Distress
timeFrame: All 7 timepoints over 36 months
measure: Psychological Distress
timeFrame: All 7 timepoints over 36 months
measure: Physical Health
timeFrame: All 7 timepoints over 36 months
measure: Daily Stressors
timeFrame: All 7 timepoints over 36 months
measure: Economic Precarity
timeFrame: All 7 timepoints over 36 months
Secondary outcomes:
measure: Access to Resources
timeFrame: All 7 timepoints over 36 months
measure: Social Support
timeFrame: All 7 timepoints over 36 months
measure: Cultural Connectedness
timeFrame: All 7 timepoints over 36 months
measure: Health Services Use
timeFrame: All 7 timepoints over 36 months
measure: English Proficiency
timeFrame: All 7 timepoints over 36 months
measure: Discrimination
timeFrame: All 7 timepoints over 36 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
References: