NCT06712147

Brief Summary

The goal of this clinical trial is to increase and strengthen connections between Latinx 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 6, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

November 26, 2024

Last Update Submit

July 27, 2025

Conditions

Keywords

mental healthpromotores de saludhelp-seekingcommunity resources

Outcome Measures

Primary Outcomes (1)

  • Attitudes Toward Seeking Professional Psychological Help Scale - Short Form

    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

Secondary Outcomes (4)

  • Mental Health Service Use

    3 month follow up and 6 month follow up.

  • Attitudes Toward Seeking Professional Psychological Help Scale - Short Form

    1 week follow up and 3 month follow up.

  • General Self-Efficacy Scale

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

  • Treatment Expectation Questionnaire

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

Study Arms (2)

Mental health use, education, and skill-building

EXPERIMENTAL

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).

Behavioral: Overcoming Life's Hurdles: Mental health education

Resources in the community

ACTIVE COMPARATOR

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).

Behavioral: Overcoming Life's Hurdles: Resources in the community

Interventions

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.

Mental health use, education, and skill-building

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.

Resources in the community

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Persons from the same household
  • First degree family member

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Jennifer A Newberry, MD, JD, MSc

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Emergency Medicine

Study Record Dates

First Submitted

November 26, 2024

First Posted

December 2, 2024

Study Start

January 6, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations