Community Health Worker Navigation to Support Mental Health

University of California (UC), Riverside

Status: Begins enrollment this month

Conditions: Service Utilization; Stress

Treatments: Behavioral: Protocolized Promotora-Led Navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT07387146

OT2OD035895 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Wait-List Control Arm - Treatment as Usual

No Intervention group

Description:

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 group

Treatment:

Behavioral: Protocolized Promotora-Led Navigation