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MHE3 Clinical Trial - Overvindelse af forhindringer

2. oktober 2026 opdateret af: Jennifer A. Newberry, Stanford University

Et Promotora-centreret fællesskabssamarbejde for at forbedre forbindelserne til mental sundhedstjeneste

The goal of this clinical trial is to increase and strengthen connections between Latino/a individuals and mental health services. Through this intervention, the investigators aim to improve mental health literacy, decrease stigma, increase coping skills, and increase mental health help seeking, even before they are in crisis. Participants will be asked to participate in six educational sessions hosted by Promotores de Salud.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

154

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • California
      • Palo Alto, California, Forenede Stater, 94304
        • Stanford University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • Has heritage or self-identifies as Hispanic and/or Latino/a
  • Must speak English or Spanish
  • Primary residence is in 95116, 95122, 95127, 95112, 95111, 95121,95148, or 95133 zip codes

Exclusion criteria:

  • Persons from the same household
  • First degree family member

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Mental health use, education, and skill-building

Participants randomly assigned to this arm will attend a 6 week educational series that will cover topics around mental health.

Data will be collected form participants at baseline (before the start of the first session), 1 week after the last session, and at 3- and 6- months after the sessions (follow ups).

The intervention group will cover educational topics around mental health including: mental health literacy, individual coping skills, stigma reduction strategies, resources for mental health support, and mental health rights.

Aktiv komparator: Resources in the community

Participants randomly assigned to this arm will attend a 6 week educational series that will cover topics on resources in the community.

Data will be collected form participants at baseline (before the start of the first session), 1 week after the last session, and at 3- and 6- months after the sessions (follow ups).

The control group will cover topics including: mental health resources in the community, violence (i.e. domestic violence), employment and education opportunities, housing and tenant rights, immigration and acculturation, and community team building and empowerment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Attitudes Toward Seeking Professional Psychological Help Scale - Short Form
Tidsramme: 6 month follow up

The ATSPPH-SF is scored 0 to 30. Items are rated on a Likert scale (e.g., strongly disagree to strongly agree), with higher scores indicating greater openness to seeking psychological help.

6 month follow up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mental Health Service Use
Tidsramme: 3 month follow up and 6 month follow up.

Measured through a study-specific, 9-item questionnaire. Self-rated mental health status question will use a multiple choice semantic differential scale ("excellent" to "poor"). Number of poor mental health days in the past month will use a numerical scale (0 to 30 days). Mental health help-seeking questions related to wanting, tried, and successfully seeing a mental health professional will use select all that apply time point response options ("never", "in the past 3 months", "within the last 4- 6 months", "over a year ago").

3 month follow up and 6 month follow up.
Attitudes Toward Seeking Professional Psychological Help Scale - Short Form
Tidsramme: 1 week follow up and 3 month follow up.

The ATSPPH-SF is scored 0 to 30. Items are rated on a Likert scale (e.g., strongly disagree to strongly agree), with higher scores indicating greater openness to seeking psychological help.

1 week follow up and 3 month follow up.
General Self-Efficacy Scale
Tidsramme: 1 week follow up, 3 month follow up, and 6-month follow up.

Measured through a 10-item questionnaire; assesses the strength of an individuals belief of their ability to respond to novel or difficult situations to deal with any associated obstacles or setbacks. Items are rated on a 4-point Likert scale (e.g., 1 = Not at all true to 4 = Exactly true), with higher scores indicating stronger self-efficacy.

1 week follow up, 3 month follow up, and 6-month follow up.
Treatment Expectation Questionnaire
Tidsramme: 1 week follow up, 3 month follow up, and 6-month follow up.

Measured through a 6 item questionnaire; measure's a participants expectations about the effectiveness of their treatment. Items are rated on a Likert scale (e.g., from "not at all" to "very much"), and higher scores indicate stronger positive expectations about the treatment.

1 week follow up, 3 month follow up, and 6-month follow up.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Jennifer A Newberry, MD, JD, MSc, Stanford University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. januar 2025

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

26. november 2024

Først indsendt, der opfyldte QC-kriterier

26. november 2024

Først opslået (Faktiske)

2. december 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. oktober 2026

Sidst verificeret

1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 77672
  • 5R01MD018201-03 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Data will be made available through presentations at national scientific meetings, publishing in peer reviewed journals, and uploading the processed data to publicly accessible servers, as appropriate. The investigators will conform with the HIPAA Privacy Rule under which protected health information may be used or disclosed by covered entities for research purposes and protect against the involuntary release of data that could identify research participants as stated in the confidentiality statement.

In accordance with guidelines set by NIH's Policy for Data Management and Sharing, data from this study will be made publicly available through Stanford's Digital Repository (SDR) and the Center for Open Science's OSF repository.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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