Community Health Worker Navigation to Support Mental Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorUniversity of California, Riverside
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Score below 14 on the Perceived Stress Scale (PSS), indicating low perceived stress and ineligibility for enrollment.
Marked emotional dysregulation such that engagement is not feasible
Significant physical dishevelment suggesting acute impairment
Apparent intoxication from alcohol or other substances
Trial design
Design model
Crossover
Treatments tested in this trial
Protocolized Promotora-Led Navigation
BehavioralParticipants 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Wait-List Control Arm - Treatment as UsualNo intervention 0 interventions
Group B: Protocolized Promotora-Led NavigationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Perceived Stress Scale (PSS-10)
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.
Time frame
Baseline, Week 12, Week 242
Depression Patient Health Questionnaire-9 (PHQ-9)
PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
Time frame
Baseline, Week 12, Week 24Secondary outcomes
1
Generalized Self-Efficacy Scale (GSES)
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.
Time frame
Baseline, Week 12, and Week 242
PROMIS General Self-Efficacy Short Form (4a)
PROMIS GSE (4 items): 1-5 scale; sum or convert to PROMIS T-score.
Time frame
Baseline, Weeks 12, and Week 243
Services Use and Benefits
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).
Time frame
Baseline, Week 12, Week 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Riverside
Lead sponsor
Cultura y Arte Nativa de las Americas (CANA)
Collaborator
Native American Health Center
Collaborator
Source ClinicalTrials.gov