Mental Health ServicesNCT06712147
MHE3 Clinical Trial - Overcoming Obstacles
A study testing Overcoming Life's Hurdles: Mental health education and Overcoming Life's Hurdles: Resources in the community in people with Mental Health Services and Community Mental Health Services, run by Stanford University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Services, Community Mental Health Services, Community Health Services
- What is being tested?
- Overcoming Life's Hurdles: Mental health education and Overcoming Life's Hurdles: Resources in the community
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Persons from the same household
- First degree family member
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Mental Health Services, Community Mental Health Services, Community Health Services, Preventive Health Services, Counseling, Community Networks
- Being tested
- Overcoming Life's Hurdles: Mental health education, Overcoming Life's Hurdles: Resources in the community
- Keywords
- mental health, promotores de salud, help-seeking, community resources
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overcoming Life's Hurdles: Mental health educationBehavioural
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.
Overcoming Life's Hurdles: Resources in the communityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Overcoming Life's Hurdles: Resources in the community |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month follow up
Secondary outcomes (4)
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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week follow up, 3 month follow up, and 6-month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start6 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health ServicesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Jennifer A. Newberry, Stanford University
- Investigators
- Jennifer A Newberry, MD, JD, MSc, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712147
- Sponsor's protocol ID
- 77672
- Other IDs
- 5R01MD018201-03
- Status last verified
- Mar 2026
- First submitted
- 26 Nov 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Promotora-centric Community Collaborative to Improve Connections to Mental Health Service
- ClinicalTrials.gov ID
- NCT06712147
- Acronym / sponsor ID
- 77672
- Conditions
- Mental Health Services, Community Mental Health Services, Community Health Services, Preventive Health Services, Counseling, Community Networks
- Keywords
- mental health, promotores de salud, help-seeking, community resources
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental health use, education, and skill-building | Experimental | Behavioral: Overcoming Life's Hurdles: Mental health educationParticipants 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 comparator | Behavioral: Overcoming Life's Hurdles: Resources in the communityParticipants 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Persons from the same household
- First degree family member
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overcoming Life's Hurdles: Mental health educationThe 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. | Behavioural | Mental health use, education, and skill-building |
| Overcoming Life's Hurdles: Resources in the communityThe 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. | Behavioural | Resources in the community |
Primary outcome
Attitudes Toward Seeking Professional Psychological Help Scale - Short Form
Time frame: 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.
4 secondary outcomes
Mental Health Service Use
Time frame: 3 month follow up and 6 month follow up.
Attitudes Toward Seeking Professional Psychological Help Scale - Short Form
Time frame: 1 week follow up and 3 month follow up.
General Self-Efficacy Scale
Time frame: 1 week follow up, 3 month follow up, and 6-month follow up.
Treatment Expectation Questionnaire
Time frame: 1 week follow up, 3 month follow up, and 6-month follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer A Newberry, MD, JD, MSc principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overcoming Life's Hurdles: Mental health education and Overcoming Life's Hurdles: Resources in the community in people with Mental Health Services and Community Mental Health Services, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attitudes Toward Seeking Professional Psychological Help Scale - Short Form (time frame: 6 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.