MHE3 Clinical Trial - Overcoming Obstacles

A Promotora-centric Community Collaborative to Improve Connections to Mental Health Service

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.

Study Overview

• Status: Recruiting
• Conditions: Counseling; Mental Health Services; Community Health Services; Community Mental Health Services; Preventive Health Services; Hispanic or Latino; Community Networks; Community Participation
• Intervention / Treatment: Behavioral: Overcoming Life's Hurdles: Mental health education; Behavioral: Overcoming Life's Hurdles: Resources in the community

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Principal Investigator; Phone Number: (312) 209-3083; Email: newberry@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: Overcoming Life's Hurdles: Mental health education; 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.
Active Comparator: 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).	Behavioral: Overcoming Life's Hurdles: Resources in the community; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental Health Service Use	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	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	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	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.

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Jennifer A Newberry, MD, JD, MSc, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: mental health; help-seeking; community resources; promotores de salud
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being
• Other Study ID Numbers: 77672; 5R01MD018201-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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 Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No