Community Health Worker Navigation to Support Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Perceived Stress Scale (PSS-10)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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).
研究组 & 干预措施
Wait-List Control Arm - Treatment as Usual
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
干预措施: Protocolized Promotora-Led Navigation (Behavioral)
结局指标
主要结局
Perceived Stress Scale (PSS-10)
时间窗: Baseline, Week 12, Week 24
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.
Depression Patient Health Questionnaire-9 (PHQ-9)
时间窗: Baseline, Week 12, Week 24
PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
次要结局
- Generalized Self-Efficacy Scale (GSES)(Baseline, Week 12, and Week 24)
- PROMIS General Self-Efficacy Short Form (4a)(Baseline, Weeks 12, and Week 24)
- Services Use and Benefits(Baseline, Week 12, Week 24)