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NCT Number: NCT07387146

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.

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Key information

Conditions

Stress Service Utilization

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cultura Y Arte Nativa De Las Americas

San Francisco, California, 94110, United States

Location status: Recruiting

Location contact

Jaime Smith

CONTACT

[email protected]

951-827-0741

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Generalized Self-Efficacy Scale (GSES)

    Time frame: Baseline, Week 12, and Week 24

    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.

  2. PROMIS General Self-Efficacy Short Form (4a)

    Time frame: Baseline, Weeks 12, and Week 24

    PROMIS GSE (4 items): 1-5 scale; sum or convert to PROMIS T-score.

  3. Services Use and Benefits

    Time frame: Baseline, Week 12, Week 24

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jaime Smith

CONTACT

[email protected]

951-827-0741

Lisa Fortuna

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of California, Riverside

Other

Collaborators

  • Cultura y Arte Nativa de las Americas (CANA)
  • Native American Health Center

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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