Community Health Worker Navigation to Support Mental Health

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 Overview

• Status: Recruiting
• Conditions: Stress; Service Utilization
• Intervention / Treatment: Behavioral: Protocolized Promotora-Led Navigation

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jaime Smith; Phone Number: 951-827-0741; Email: jaime.smith@medsch.ucr.edu
• Study Contact Backup: Name: Lisa Fortuna; Email: lisa.fortuna@medsch.ucr.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Recruiting
      • Cultura Y Arte Nativa De Las Americas
      • Contact: Jaime Smith; Phone Number: 951-827-0741; Email: jaime.smith@medsch.ucr.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Wait-List Control Arm - Treatment as Usual; 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.
Experimental: Protocolized Promotora-Led Navigation	Behavioral: Protocolized Promotora-Led Navigation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, Week 12, Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	Baseline, Week 12, Week 24

Collaborators and Investigators

• Sponsor: University of California, Riverside
• Collaborators: Cultura y Arte Nativa de las Americas (CANA); Native American Health Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): September 19, 2028

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: OT2OD035895 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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