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Interventie om ongelijksoortige gevolgen voor de geestelijke gezondheid van COVID-19-pandemie op Latinx en Afrikaanse nieuwkomers aan te pakken (RIWP+)

4 november 2026 bijgewerkt door: University of New Mexico

Op de gemeenschap gebaseerde interventie voor geestelijke gezondheidszorg op meerdere niveaus om structurele ongelijkheden en nadelige ongelijksoortige gevolgen van de COVID-19-pandemie op Latinx-immigranten en Afrikaanse vluchtelingen aan te pakken

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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

1212

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87131
        • University of New Mexico

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Random Sample of Latinx Immigrants

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

Experimenteel: 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

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

Andere namen:
  • Project Welzijn Vluchtelingen (RWP)
  • Project Welzijn Immigranten (IWP)
Geen tussenkomst: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Psychological Distress
Tijdsspanne: All 7 timepoints over 36 months

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
Tijdsspanne: All 7 timepoints over 36 months

PHQ-9

All 7 timepoints over 36 months
Psychological Distress
Tijdsspanne: All 7 timepoints over 36 months

GAD-7

All 7 timepoints over 36 months
Physical Health
Tijdsspanne: All 7 timepoints over 36 months

WHODAS-2

All 7 timepoints over 36 months
Daily Stressors
Tijdsspanne: All 7 timepoints over 36 months

Perceived Stress Scale

All 7 timepoints over 36 months
Economic Precarity
Tijdsspanne: All 7 timepoints over 36 months

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

All 7 timepoints over 36 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Access to Resources
Tijdsspanne: All 7 timepoints over 36 months

Satisfaction with Resources Scale

All 7 timepoints over 36 months
Social Support
Tijdsspanne: All 7 timepoints over 36 months

Medical Outcomes Study Social Support Survey, 8-item version

All 7 timepoints over 36 months
Cultural Connectedness
Tijdsspanne: All 7 timepoints over 36 months

Language, Identity, and Behavior Acculturation Scale

All 7 timepoints over 36 months
Health Services Use
Tijdsspanne: All 7 timepoints over 36 months

Composite International Diagnostic Interview (selected questions)

All 7 timepoints over 36 months
English Proficiency
Tijdsspanne: All 7 timepoints over 36 months

4 items about understanding, reading, speaking, and writing

All 7 timepoints over 36 months
Discrimination
Tijdsspanne: All 7 timepoints over 36 months

Experience of Discrimination (EOD) Scale

All 7 timepoints over 36 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 oktober 2021

Primaire voltooiing (Werkelijk)

31 juli 2025

Studie voltooiing (Geschat)

30 december 2026

Studieregistratiedata

Eerst ingediend

22 oktober 2021

Eerst ingediend dat voldeed aan de QC-criteria

22 oktober 2021

Eerst geplaatst (Werkelijk)

25 oktober 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2026

Laatste update ingediend die voldeed aan QC-criteria

4 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 07521
  • R01MH127733 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

Within 6 months of the end of data collection in Year 4

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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