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

Multilevel Community-Based Mental Health Intervention to Address Structural Inequities and Adverse Disparate Consequences of COVID-19 Pandemic on Latinx Immigrant and African Refugees

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stress, Emotional; Mental Health Disorder; Mental Health Issue; Economic Problems
• Intervention / Treatment: Behavioral: Refugee and Immigrant Well-being Project (RIWP)

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 Type: Interventional
• Enrollment (Actual): 1212
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Goodkind, PhD; Phone Number: 505-280-4391; Email: jgoodkin@unm.edu
• Study Contact Backup: Name: Julia Hess, PhD; Phone Number: 505-507-6043; Email: jmhess@salud.unm.edu

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological Distress	DSM Level 1 Cross-Cutting Symptom Measure-Adult and COVID-19 and Mental Health Impacts Scale (from PhenX Toolkit)	All 5 timepoints over 32 months
Psychological Distress	PHQ-9	All 5 timepoints over 32 months
Psychological Distress	GAD-7	All 5 timepoints over 32 months
Physical Health	WHODAS-2	All 5 timepoints over 32 months
Daily Stressors	Perceived Stress Scale	All 5 timepoints over 32 months
Economic Precarity	Job Insecurity General Social Survey 2018 Questions and RAND American Life Panel Impacts of COVID-19 Survey	All 5 timepoints over 32 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access to Resources	Satisfaction with Resources Scale	All 5 timepoints over 32 months
Social Support	Medical Outcomes Study Social Support Survey, 8-item version	All 5 timepoints over 32 months
Cultural Connectedness	Language, Identity, and Behavior Acculturation Scale	All 5 timepoints over 32 months
Health Services Use	Composite International Diagnostic Interview (selected questions)	All 5 timepoints over 32 months
English Proficiency	4 items about understanding, reading, speaking, and writing	All 5 timepoints over 32 months
Discrimination	Experience of Discrimination (EOD) Scale	All 5 timepoints over 32 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Latinx immigrant; African refugee
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Mental Disorders
• Other Study ID Numbers: 07521; R01MH127733 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

After all analyses are completed and presentations/publications are finalized, a de-identified dataset will be available to other researchers, communities, or providers, upon request. All requests would have to be approved by the Community Advisory Council and would have to demonstrate that the proposed use of the data would contribute to the reduction of mental health disparities (e.g., through improved detection, diagnosis, treatment or prevention of mental illness or through contributing to knowledge of these issues) and would not harm any individuals or communities (e.g., through naïve use of the data that might result in misrepresentation of the experiences of Latinx immigrants or African refugee individuals, families, or communities).

Also, the data will be entered and available through the NIMH Data Archive.

• IPD Sharing Time Frame: Within 6 months of the end of data collection in Year 4
• IPD Sharing Access Criteria: The NDA provides basic descriptive and aggregate summary information for general public use. Such summary information may include summary counts and general statistics on completed assessment instruments. Access to subject level datasets submitted and stored in the NDA will only be provided for research purposes through the completion of the NDA Data Use Certification: OMB Control Number: 0925-0667. For the majority of the data available in the NDA, Data Use Certifications will only be accepted from researchers who are sponsored by an institution registered in the NIH's eRA Commons with an active Federal-wide Assurance issued through the Office for Human Research Protections (OHRP). Additionally, the application must include a reason for access related to scientific investigation, scholarship or teaching, or other form of research.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No