MHE3 Clinical Trial - Overcoming Obstacles
A Promotora-centric Community Collaborative to Improve Connections to Mental Health Service
2 other identifiers
interventional
192
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
1 active site
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
CompletedFirst Posted
Study publicly available on registry
December 2, 2024
CompletedStudy Start
First participant enrolled
January 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedJuly 29, 2025
July 1, 2025
1.2 years
November 26, 2024
July 27, 2025
Conditions
Keywords
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
EXPERIMENTALParticipants 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).
Resources in the community
ACTIVE COMPARATORParticipants 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).
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.
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer A Newberry, MD, JD, MSc
Stanford University
Central Study Contacts
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
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
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.