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Intervento per affrontare le diverse conseguenze sulla salute mentale della pandemia di COVID-19 sui latini e sui nuovi arrivati ​​africani (RIWP+)

4 novembre 2026 aggiornato da: University of New Mexico

Intervento di salute mentale multilivello basato sulla comunità per affrontare le disuguaglianze strutturali e le conseguenze avverse disparate della pandemia di COVID-19 sugli immigrati latini e sui rifugiati africani

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1212

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87131
        • University of New Mexico

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Random Sample of Latinx Immigrants

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

Sperimentale: 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

Altri nomi:
  • Progetto per il benessere dei rifugiati (RWP)
  • Progetto Benessere Immigrati (IWP)
Nessun intervento: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Psychological Distress
Lasso di tempo: 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
Lasso di tempo: All 7 timepoints over 36 months

PHQ-9

All 7 timepoints over 36 months
Psychological Distress
Lasso di tempo: All 7 timepoints over 36 months

GAD-7

All 7 timepoints over 36 months
Physical Health
Lasso di tempo: All 7 timepoints over 36 months

WHODAS-2

All 7 timepoints over 36 months
Daily Stressors
Lasso di tempo: All 7 timepoints over 36 months

Perceived Stress Scale

All 7 timepoints over 36 months
Economic Precarity
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Access to Resources
Lasso di tempo: All 7 timepoints over 36 months

Satisfaction with Resources Scale

All 7 timepoints over 36 months
Social Support
Lasso di tempo: All 7 timepoints over 36 months

Medical Outcomes Study Social Support Survey, 8-item version

All 7 timepoints over 36 months
Cultural Connectedness
Lasso di tempo: All 7 timepoints over 36 months

Language, Identity, and Behavior Acculturation Scale

All 7 timepoints over 36 months
Health Services Use
Lasso di tempo: All 7 timepoints over 36 months

Composite International Diagnostic Interview (selected questions)

All 7 timepoints over 36 months
English Proficiency
Lasso di tempo: All 7 timepoints over 36 months

4 items about understanding, reading, speaking, and writing

All 7 timepoints over 36 months
Discrimination
Lasso di tempo: All 7 timepoints over 36 months

Experience of Discrimination (EOD) Scale

All 7 timepoints over 36 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

18 ottobre 2021

Completamento primario (Effettivo)

31 luglio 2025

Completamento dello studio (Stimato)

30 dicembre 2026

Date di iscrizione allo studio

Primo inviato

22 ottobre 2021

Primo inviato che soddisfa i criteri di controllo qualità

22 ottobre 2021

Primo Inserito (Effettivo)

25 ottobre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 07521
  • R01MH127733 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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