Community Health Worker Navigation to Support Mental Health

Overview

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.

Interventions

• 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 par

Primary outcome measures

• Perceived Stress Scale (PSS-10) [Time frame: Baseline, Week 12, Week 24]
• Depression Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline, Week 12, Week 24]

Secondary outcome measures (3)

• 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• Cultura Y Arte Nativa De Las Americas — San Francisco

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. PMID 38991816

Identifiers

NCT: NCT07387146 · OT2OD035895

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗