Culture and Well-Being for Latinos: Study Protocol for Cultural-Social Engagement and Suicide Among Hispanics (K23MH125078)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Cultural-Social Engagement (A)
研究概览
简要总结
The proposed K23 study is an intervention study using an experimental therapeutics approach. This pilot RCT asks: "Does SOCIAL-ENGAGE increase cultural-social engagement and decrease suicide risk among Spanish-speaking adults?" We will first optimize a behavioral intervention - SOCIAL ENGAGE (S-ENGAGE) - for target engagement using human-centered design approaches with Spanish-speaking adults at risk for suicide (n=5) and then conduct a pilot RCT (n=60) to test target engagement (cultural-social engagement) and clinical impact (suicide risk) of S-ENGAGE with this population. The ultimate goal is for S-ENGAGE to be offered as a suicide prevention program for Hispanics at risk for suicide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Identify as Hispanic/Latino adult (age 18+);
- •Primary Spanish-Speaker;
- •Patient in the UR health system;
- •Low cultural-social engagement (i.e., score ≤ 2 on the adapted Berkman-Syme Social Network Index);
- •Elevated suicide risk (i.e., presence of passive or active suicide ideation in the past month on the Columbia-Suicide Severity Rating Scale [C-SSRS]).
排除标准
- •Medical or psychiatric comorbidities that impair ability to consent (e.g., active psychotic or manic episode, cognitive impairment).
研究组 & 干预措施
Social Engage (S-ENGAGE)
S-ENGAGE is a skills-based psychotherapy that focuses on helping patients engage in meaningful rewarding social activities. Subjects will receive 10 one-hour individual sessions of S-ENGAGE over 10 weeks.
干预措施: Social Engage (S-ENGAGE) (Behavioral)
The Healthy Lifestyles Education Program
The healthy lifestyles education program consists of a notebook containing evidence-based educational material on mental health, physical activity, and information on community resources. Study staff meet with participants once, individually, for 1 hour to review each section and answer questions participants might have.
干预措施: The Healthy Lifestyles Education Program (Behavioral)
结局指标
主要结局
Change in Cultural-Social Engagement (A)
时间窗: Baseline and 10 weeks
Average number of cultural-social interactions (measured via EMA), with greater number indicating greater cultural-social engagement (i.e., better outcome).
Change in Cultural-Social Engagement (B)
时间窗: Baseline and 10 weeks
Time spent in positive Spanish-language conversations (measured via passive monitoring of conversations), with more time indicating greater cultural-social engagement (i.e., better outcome).
Change in Cultural-Social Engagement (C)
时间窗: Baseline and 10 weeks
Number of visits to cultural-social settings outside the home (measured via GPS), with greater number indicating greater cultural-social engagement (i.e., better outcome).
Change in Cultural-Social Engagement (D)
时间窗: Baseline and 10 weeks
Self-reported feelings of belonging to Hispanic cultural groups (measured via EMA with the Interpersonal Needs Questionnaire), with greater scores indicating greater cultural-social engagement (i.e., better outcome).
次要结局
- Change in Suicide Risk (A)(Baseline and 10 weeks)
- Change in Suicide Risk (B)(Baseline and 10 weeks)
研究者
Caroline Silva
Assistant Professor
University of Rochester