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| Name | Class |
|---|---|
| Cultura y Arte Nativa de las Americas (CANA) | UNKNOWN |
| Native American Health Center | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wait-List Control Arm - Treatment as Usual | No Intervention | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protocolized Promotora-Led Navigation | Behavioral | 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 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale (PSS-10) | Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
| Baseline, Week 12, Week 24 |
| 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. | Baseline, Week 12, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Are 18 years of age or older
Exclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaime Smith | Contact | 951-827-0741 | jaime.smith@medsch.ucr.edu | |
| Lisa Fortuna | Contact | lisa.fortuna@medsch.ucr.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cultura Y Arte Nativa De Las Americas | Recruiting | San Francisco | California | 94110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38991816 | Background | 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. |
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| Baseline, Week 12, and Week 24 |
| PROMIS General Self-Efficacy Short Form (4a) | PROMIS GSE (4 items): 1-5 scale; sum or convert to PROMIS T-score. | Baseline, Weeks 12, and Week 24 |
| 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). | Baseline, Week 12, Week 24 |