RecruitingNot ApplicableNCT07387146

Community Health Worker Navigation to Support Mental Health


Sponsor

University of California, Riverside

Enrollment

80 participants

Start Date

Apr 16, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Inclusion Criteria3

  • 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 Criteria10

  • 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).

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Interventions

BEHAVIORALProtocolized 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.


Locations(1)

Cultura Y Arte Nativa De Las Americas

San Francisco, California, United States

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NCT07387146


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