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

NCT05092542 | Active Not Recruiting DMC

• 2 other identifiers: 07521R01MH127733
• Study Type: interventional
• Target: 1,212
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Issue; Mental Health Disorder; Stress, Emotional; Economic Problems

Keywords

Latinx immigrant; African refugee

Outcome Measures

Primary Outcomes (6)

• Psychological Distress

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

  All 7 timepoints over 36 months

• Psychological Distress

  PHQ-9

  All 7 timepoints over 36 months

• Psychological Distress

  GAD-7

  All 7 timepoints over 36 months

• Physical Health

  WHODAS-2

  All 7 timepoints over 36 months

• Daily Stressors

  Perceived Stress Scale

  All 7 timepoints over 36 months

• Economic Precarity

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

  All 7 timepoints over 36 months

Secondary Outcomes (6)

• Access to Resources

  All 7 timepoints over 36 months

• Social Support

  All 7 timepoints over 36 months

• Cultural Connectedness

  All 7 timepoints over 36 months

• Health Services Use

  All 7 timepoints over 36 months

• English Proficiency

  All 7 timepoints over 36 months

Study Arms (3)

Random Sample of Latinx Immigrants

NO INTERVENTION

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

Refugee & Immigrant Well-being Project (RIWP) Intervention

EXPERIMENTAL

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)

Treatment-as-usual Waitlist Control Group

NO INTERVENTION

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

Interventions

Refugee and Immigrant Well-being Project (RIWP) BEHAVIORAL

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

Also known as: Refugee Well-being Project (RWP), Immigrant Well-being Project (IWP)

Refugee & Immigrant Well-being Project (RIWP) Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Mental Disorders; Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: October 25, 2021
• Study Start: October 18, 2021
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 6 months of the end of data collection in Year 4
• 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.

Locations

US (1)