StressNCT07387146
Community Health Worker Navigation to Support Mental Health
A study testing Protocolized Promotora-Led Navigation in people with Stress and Service Utilization, run by University of California, Riverside at 1 site in United States.
Trial summary
This pilot study tests the feasibility and preliminary impact of a protocolized promotora-led navigation intervention to improve behavioral health access among Latinx and Native American underserved adults. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Stress, Service Utilization
- What is being tested?
- Protocolized Promotora-Led Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2026to 19 Sep 2028
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are 18 years of age or older
- Speak either English or Spanish
- Report moderate or higher perceived stress, defined as scoring 14 or above on the Perceived Stress Scale (PSS)
Who cannot join
- Score below 14 on the Perceived Stress Scale (PSS), indicating low perceived stress and ineligibility for enrollment.
- Endorse suicidal ideation on PHQ-9 item 9 (any score > 0) and score at moderate to high risk on the Columbia Suicide Severity Rating Scale (C-SSRS) as assessed by the study psychiatrist/PI.
- Report verbal or written suicidal ideation to any study team member. Exhibit any indication of suicidality or threats of harm to others reported or observed by research staff.
- Score 16 or higher on the AUDIT, indicating severe alcohol use. Score 6 or higher on the DAST-10, indicating severe drug use. Arrive at screening intoxicated, impairing informed consent capacity or ability to participate.
- Present to the screening or interview space with any of the following concerning clinical signs:
- Marked emotional dysregulation such that engagement is not feasible
Show all 10Show fewer
- Significant physical dishevelment suggesting acute impairment
- Apparent intoxication from alcohol or other substances
- Possible hallucinations or other signs of psychosis
- Any indication that psychological status may compromise safe participation Are unable to complete the screening process due to any of the above concerns (screening will be halted and the participant will be referred for appropriate support).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lisa Fortuna contact
United States1 site, 1 recruiting
- Recruiting
Cultura Y Arte Nativa De Las Americas
San Francisco, California, 94110
Jaime Smith, 951-827-0741, jaime.smith@medsch.ucr.edu
About this study
This pilot study tests the feasibility and preliminary impact of a protocolized promotora-led navigation intervention to improve behavioral health access among Latinx and Native American underserved adults. The study is embedded within a community cultural center, leveraging a trusted and culturally grounded environment for recruitment and intervention delivery. Participants will be randomized 1:1 to receive either the promotora navigation intervention or a treatment-as-usual (TAU) condition consisting of cultural resources and promotora-supported wait-list control. The TAU group will continue to receive any usual care during the study period and will be offered the protocolized navigation intervention after completing follow-up assessments. Primary outcomes include feasibility, acceptability, and preliminary changes in behavioral health access, stress reduction, self-efficacy, and wellbeing.
- Conditions
- Stress, Service Utilization
- Being tested
- Protocolized Promotora-Led Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocolized Promotora-Led NavigationBehavioural
Participants in this group will receive the CAPAZ protocolized navigation intervention, in which trained promotoras-supported by the Lead Study Navigator and the Principal Investigator (PI)-deliver structured, individualized health navigation. The intervention will follow a defined protocol that includes behavioral health screening, care coordination, and facilitated referrals to mental health services, primary care, and social-cultural or community resources as needed. The model also allows participants to integrate cultural and traditional healing practices into their care plan. Each participant will receive up to six promotora sessions over 12 weeks, focusing on improving access to care, stress reduction, and overall wellbeing.
| Study group | Role | What they receive |
|---|---|---|
| Wait-List Control Arm - Treatment as Usual | No intervention | Promotora Support for Cultural Healing Practices: Participants assigned to the wait-list control condition will receive standard promotora support as typically provided through CANA's Indigenous Peoples Cultural Arts Healing Center and the Native American Health Center (NAHC), which may include general health promotion, wellness education, and linkage to cultural healing resources. After completing the 12-week wait-list period and follow-up assessment, participants in this group will be offered the full CAPAZ protocolized navigation intervention. |
| Protocolized Promotora-Led Navigation | Experimental | Not described Receives: Behavioral: Protocolized Promotora-Led Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS-10)
Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
- Scores ranging from 0-13 would be considered low stress.
- Scores ranging from 14-26 would be considered moderate stress.
- Scores ranging from 27-40 would be considered high perceived stress.
Measured: Baseline, Week 12, Week 24
Depression Patient Health Questionnaire-9 (PHQ-9)
PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
Measured: Baseline, Week 12, Week 24
Secondary outcomes (3)
Generalized Self-Efficacy Scale (GSES)
The General Self-Efficacy Scale measures ones perceived self-efficacy or belief in their ability to cope with different situations and accomplish goals. For each item there is a four choice response scoring from 1-4 and then summed to give a total score with the higher the score the higher the individual's sense of self-efficacy. GSE (10 items): 1-4 scale; sum (10-40); higher = greater self-efficacy.
Measured: Baseline, Week 12, and Week 24
PROMIS General Self-Efficacy Short Form (4a)
PROMIS GSE (4 items): 1-5 scale; sum or convert to PROMIS T-score.
Measured: Baseline, Weeks 12, and Week 24
Services Use and Benefits
These researcher-designed measure document services used through navigator referral, degree of difficulty in accessing services, and self-rating of perceived improvement. The measure is available in English and Spanish. Purpose: To understand your experiences using community, cultural, and health services, and the benefits of support from a promotora or community health worker (CHW).
Measured: Baseline, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start16 Apr 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion19 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Riverside
- Sponsor type
- University, hospital or other
- Collaborators
- Cultura y Arte Nativa de las Americas (CANA), Native American Health Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387146
- Sponsor's protocol ID
- OT2OD035895
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alfaro A, Alfaro E, Coto E, Gomez C, Montejo D, Pozo H, Pena R, Rivera C, Cibrian JGR, Rodriguez M, Salazar D, Sierra R, Ulloa J, Uribe V, Flores P, Camarena A. Somos Esenciales, We are Essential: Our Mental Health is Essential. Research for, by and of the Latinx Community in the Mission District during the Pandemic. Acad Pediatr. 2024 Jul;24(5S):95-97. doi: 10.1016/j.acap.2024.01.025.
PubMed 38991816
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Worker Navigation to Support Mental Health
- ClinicalTrials.gov ID
- NCT07387146
- Acronym / sponsor ID
- OT2OD035895
- Conditions
- Stress, Service Utilization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, RiversideUniversity, hospital or other
- Collaborators
- Cultura y Arte Nativa de las Americas (CANA), Native American Health Center
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 19 Sep 2028 (estimated)
- First posted
- 4 Feb 2026 (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.
This pilot study tests the feasibility and preliminary impact of a protocolized promotora-led navigation intervention to improve behavioral health access among Latinx and Native American underserved adults. The study is embedded within a community cultural center, leveraging a trusted and culturally grounded environment for recruitment and intervention delivery. Participants will be randomized 1:1 to receive either the promotora navigation intervention or a treatment-as-usual (TAU) condition consisting of cultural resources and promotora-supported wait-list control. The TAU group will continue to receive any usual care during the study period and will be offered the protocolized navigation intervention after completing follow-up assessments. Primary outcomes include feasibility, acceptability, and preliminary changes in behavioral health access, stress reduction, self-efficacy, and wellbeing.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait-List Control Arm - Treatment as Usual | No intervention | –Promotora Support for Cultural Healing Practices: Participants assigned to the wait-list control condition will receive standard promotora support as typically provided through CANA's Indigenous Peoples Cultural Arts Healing Center and the Native American Health Center (NAHC), which may include general health promotion, wellness education, and linkage to cultural healing resources. After completing the 12-week wait-list period and follow-up assessment, participants in this group will be offered the full CAPAZ protocolized navigation intervention. |
| Protocolized Promotora-Led Navigation | Experimental | Behavioral: Protocolized Promotora-Led Navigation |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are 18 years of age or older
Key exclusion criteria (10 listed)
- Score below 14 on the Perceived Stress Scale (PSS), indicating low perceived stress and ineligibility for enrollment.
- Endorse suicidal ideation on PHQ-9 item 9 (any score > 0) and score at moderate to high risk on the Columbia Suicide Severity Rating Scale (C-SSRS) as assessed by the study psychiatrist/PI.
- Report verbal or written suicidal ideation to any study team member. Exhibit any indication of suicidality or threats of harm to others reported or observed by research staff.
- Score 16 or higher on the AUDIT, indicating severe alcohol use. Score 6 or higher on the DAST-10, indicating severe drug use. Arrive at screening intoxicated, impairing informed consent capacity or ability to participate.
- Present to the screening or interview space with any of the following concerning clinical signs:
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 |
|---|---|---|
| Protocolized Promotora-Led NavigationParticipants in this group will receive the CAPAZ protocolized navigation intervention, in which trained promotoras-supported by the Lead Study Navigator and the Principal Investigator (PI)-deliver structured, individualized health navigation. The intervention will follow a defined protocol that includes behavioral health screening, care coordination, and facilitated referrals to mental health services, primary care, and social-cultural or community resources as needed. The model also allows participants to integrate cultural and traditional healing practices into their care plan. Each participant will receive up to six promotora sessions over 12 weeks, focusing on improving access to care, stress reduction, and overall wellbeing. | Behavioural | Protocolized Promotora-Led Navigation |
Primary outcome
Perceived Stress Scale (PSS-10)
Time frame: Baseline, Week 12, Week 24
Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. * Scores ranging from 0-13 would be considered low stress. * Scores ranging from 14-26 would be considered moderate stress. * Scores ranging from 27-40 would be considered high perceived stress.
Depression Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, Week 12, Week 24
PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
3 secondary outcomes
Generalized Self-Efficacy Scale (GSES)
Time frame: Baseline, Week 12, and Week 24
PROMIS General Self-Efficacy Short Form (4a)
Time frame: Baseline, Weeks 12, and Week 24
Services Use and Benefits
Time frame: Baseline, Week 12, Week 24
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 4 May 2026.
- Background: PubMed 38991816Alfaro A, Alfaro E, Coto E, Gomez C, Montejo D, Pozo H, Pena R, Rivera C, Cibrian JGR, Rodriguez M, Salazar D, Sierra R, Ulloa J, Uribe V, Flores P, Camarena A. Somos Esenciales, We are Essential: Our Mental Health is Essential. Research for, by and of the Latinx Community in the Mission District during the Pandemic. Acad Pediatr. 2024 Jul;24(5S):95-97. doi: 10.1016/j.acap.2024.01.025.
- Individual participant dataSharing planned: No
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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.
Lisa Fortuna contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocolized Promotora-Led Navigation in people with Stress and Service Utilization, run by University of California, Riverside 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 10 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: looking for participants now, as of the sponsor's last update on 4 May 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?
Contact Jaime Smith (951-827-0741, jaime.smith@medsch.ucr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS-10) (time frame: Baseline, Week 12, Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07387146, which also lists 1 linked publication.
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 4 May 2026.