RIWP+: Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers

Sponsor
University of New Mexico (Other)
Overall Status
Recruiting
CT.gov ID
NCT05092542
Collaborator
National Institute of Mental Health (NIMH) (NIH)
1,200
1
3
57.4
20.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Refugee and Immigrant Well-being Project (RIWP)
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1200 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
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).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).
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 18, 2021
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Jul 31, 2026

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Random Sample of Latinx Immigrants

random sample comparison group of Latinx immigrants who are NOT randomly assigned to a treatment condition

Experimental: Refugee & Immigrant Well-being Project (RIWP) Intervention

6-month mental health intervention that pairs university students with newcomers to engage in mutual learning, resource mobilization, and social change efforts

Behavioral: Refugee and Immigrant Well-being Project (RIWP)
6-month mental health intervention that pairs university students with newcomers to engage in mutual learning, resource mobilization, and social change efforts
Other Names:
  • Refugee Well-being Project (RWP)
  • Immigrant Well-being Project (IWP)
  • No Intervention: Treatment-as-usual Waitlist Control Group

    participants recruited from community-based organizations receive usual services from community-based organizations and may participate in RIWP intervention in Year 3

    Outcome Measures

    Primary Outcome Measures

    1. Psychological Distress [All 5 timepoints over 32 months]

      DSM Level 1 Cross-Cutting Symptom Measure-Adult and COVID-19 and Mental Health Impacts Scale (from PhenX Toolkit)

    2. Psychological Distress [All 5 timepoints over 32 months]

      PHQ-9

    3. Psychological Distress [All 5 timepoints over 32 months]

      GAD-7

    4. Physical Health [All 5 timepoints over 32 months]

      WHODAS-2

    5. Daily Stressors [All 5 timepoints over 32 months]

      Perceived Stress Scale

    6. Economic Precarity [All 5 timepoints over 32 months]

      Job Insecurity General Social Survey 2018 Questions and RAND American Life Panel Impacts of COVID-19 Survey

    Secondary Outcome Measures

    1. Access to Resources [All 5 timepoints over 32 months]

      Satisfaction with Resources Scale

    2. Social Support [All 5 timepoints over 32 months]

      Medical Outcomes Study Social Support Survey, 8-item version

    3. Cultural Connectedness [All 5 timepoints over 32 months]

      Language, Identity, and Behavior Acculturation Scale

    4. Health Services Use [All 5 timepoints over 32 months]

      Composite International Diagnostic Interview (selected questions)

    5. English Proficiency [All 5 timepoints over 32 months]

      4 items about understanding, reading, speaking, and writing

    6. Discrimination [All 5 timepoints over 32 months]

      Experience of Discrimination (EOD) Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of New Mexico Albuquerque New Mexico United States 87131

    Sponsors and Collaborators

    • University of New Mexico
    • National Institute of Mental Health (NIMH)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of New Mexico
    ClinicalTrials.gov Identifier:
    NCT05092542
    Other Study ID Numbers:
    • 07521
    • R01MH127733
    First Posted:
    Oct 25, 2021
    Last Update Posted:
    Jun 1, 2022
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of New Mexico
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 1, 2022