Community Health Worker Navigation to Support Mental Health (NCT07387146) | Clinical Trial Compass
RecruitingNot Applicable
Community Health Worker Navigation to Support Mental Health
United States80 participantsStarted 2026-04-16
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …