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 range
18 Years – 120 Years
Sex
ALL
See this in plain English?
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.