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

Primary Purpose

Mental Health Issue, Mental Health Disorder, Stress, Emotional

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Refugee and Immigrant Well-being Project (RIWP)
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Health Issue focused on measuring Latinx immigrant, African refugee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of New Mexico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

Random Sample of Latinx Immigrants

Refugee & Immigrant Well-being Project (RIWP) Intervention

Treatment-as-usual Waitlist Control Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 22, 2021
Last Updated
June 16, 2023
Sponsor
University of New Mexico
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05092542
Brief Title
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Acronym
RIWP+
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue, Mental Health Disorder, Stress, Emotional, Economic Problems
Keywords
Latinx immigrant, African refugee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Random Sample of Latinx Immigrants
Arm Type
No Intervention
Arm Description
random sample comparison group of Latinx immigrants who are NOT randomly assigned to a treatment condition
Arm Title
Refugee & Immigrant Well-being Project (RIWP) Intervention
Arm Type
Experimental
Arm Description
6-month mental health intervention that pairs university students with newcomers to engage in mutual learning, resource mobilization, and social change efforts
Arm Title
Treatment-as-usual Waitlist Control Group
Arm Type
No Intervention
Arm Description
participants recruited from community-based organizations receive usual services from community-based organizations and may participate in RIWP intervention in Year 3
Intervention Type
Behavioral
Intervention Name(s)
Refugee and Immigrant Well-being Project (RIWP)
Other Intervention Name(s)
Refugee Well-being Project (RWP), Immigrant Well-being Project (IWP)
Intervention Description
6-month mental health intervention that pairs university students with newcomers to engage in mutual learning, resource mobilization, and social change efforts
Primary Outcome Measure Information:
Title
Psychological Distress
Description
DSM Level 1 Cross-Cutting Symptom Measure-Adult and COVID-19 and Mental Health Impacts Scale (from PhenX Toolkit)
Time Frame
All 5 timepoints over 32 months
Title
Psychological Distress
Description
PHQ-9
Time Frame
All 5 timepoints over 32 months
Title
Psychological Distress
Description
GAD-7
Time Frame
All 5 timepoints over 32 months
Title
Physical Health
Description
WHODAS-2
Time Frame
All 5 timepoints over 32 months
Title
Daily Stressors
Description
Perceived Stress Scale
Time Frame
All 5 timepoints over 32 months
Title
Economic Precarity
Description
Job Insecurity General Social Survey 2018 Questions and RAND American Life Panel Impacts of COVID-19 Survey
Time Frame
All 5 timepoints over 32 months
Secondary Outcome Measure Information:
Title
Access to Resources
Description
Satisfaction with Resources Scale
Time Frame
All 5 timepoints over 32 months
Title
Social Support
Description
Medical Outcomes Study Social Support Survey, 8-item version
Time Frame
All 5 timepoints over 32 months
Title
Cultural Connectedness
Description
Language, Identity, and Behavior Acculturation Scale
Time Frame
All 5 timepoints over 32 months
Title
Health Services Use
Description
Composite International Diagnostic Interview (selected questions)
Time Frame
All 5 timepoints over 32 months
Title
English Proficiency
Description
4 items about understanding, reading, speaking, and writing
Time Frame
All 5 timepoints over 32 months
Title
Discrimination
Description
Experience of Discrimination (EOD) Scale
Time Frame
All 5 timepoints over 32 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://s3.amazonaws.com/nda.nih.gov/Documents/NIMH+Data+Archive+Policy.pdf

Learn more about this trial

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

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