Community Health Worker Navigation to Support Mental Health

NCT07387146 | Recruiting

• 1 other identifier: OT2OD035895
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Generalized Self-Efficacy Scale (GSES)

  Baseline, Week 12, and Week 24

• PROMIS General Self-Efficacy Short Form (4a)

  Baseline, Weeks 12, and Week 24

• Services Use and Benefits

  Baseline, Week 12, Week 24

Study Arms (2)

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

Interventions

Protocolized Promotora-Led Navigation BEHAVIORAL

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.

Protocolized Promotora-Led Navigation

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Cultura Y Arte Nativa De Las Americas

San Francisco, California, 94110, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 38991816 BACKGROUND

Central Study Contacts

Jaime Smith

CONTACT

951-827-0741; jaime.smith@medsch.ucr.edu

Lisa Fortuna

CONTACT

lisa.fortuna@medsch.ucr.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 4, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): September 19, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)