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临床试验/NCT06627764
NCT06627764招募中不适用

SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Immigrant Families

Duke University2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年6月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
2
主要终点
Change in Parent Acculturative stress as measured by the Hispanic Stress Inventory (HSI-2) Immigrant Version

研究概览

简要总结

This study aims to prevent syndemic health conditions by decreasing acculturative stress and promoting resilience via SER Familia (Salud, Estrés y Resilencia en Familias/ Health, Stress, and Resilience in Families), a family-based intervention. SER Familia is a six-session intervention co-developed and delivered by community health workers (CHWs) that uses strategies to reduce acculturative stress, promote resilience, improve parent-child and family level health, while simultaneously helping families maintain strong social networks and better navigate community resources to address social determinants of health (SDOH). More specifically, investigators aim to: 1) Examine the efficacy of SER Familia to prevent or reduce the syndemic comprised of substance abuse, IPV, HIV risk, depression, and anxiety among Parents and Youth; and 2) Identify how individual, family, and community mechanisms of change related to acculturative stress and resilience mediates the effect of SER Familia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible participants must identify as Hispanic/Latino/a/x/e,
  • be a first generation immigrant parent or parental figure (Parent)
  • have a child (Youth) aged 12-17
  • speak English and/or Spanish

排除标准

  • Families planning to move within two years will be excluded

研究组 & 干预措施

Familia SER (Salud, Estrés y Resilencia) Group

Experimental

Participants will attend six intervention sessions.

干预措施: SER Familia (Behavioral)

Control Group

No Intervention

Participants will not receive SER Familia sessions.

结局指标

主要结局

Change in Parent Acculturative stress as measured by the Hispanic Stress Inventory (HSI-2) Immigrant Version

时间窗: From Enrollment to end of treatment at 6 weeks

The immigrant version of the HSI-2 includes 10 stress subscales. For each item, participants indicated whether they had experienced the stressor (Yes / No). If participants reported experiencing a stressor, then they rated how stressful the event was on a 5-point Likert scale (1= Not at all worried / tense; 2 = A little worried / tense; 3 = Moderately worried / tense; 4 = Very worried/ tense; 5 = Extremely worried/ tense). The total score ranges from 94 to 470, where a higher score indicates greater stress.

Change in Youth Acculturative stress as measured by the Hispanic Stress Inventory - Adolescent (HSI-A)

时间窗: From Enrollment to end of treatment at 6 weeks

The HSI-A includes 8 stress subscales. For each item, participants indicated whether they had experienced the stressor (Yes / No). If participants reported experiencing a stressor, then they rated how stressful the event was on a 5-point Likert scale (1= Not at all worried / tense; 2 = A little worried / tense; 3 = Moderately worried / tense; 4 = Very worried/ tense; 5 = Extremely worried/ tense). The total score ranges from 72 to 360, where a higher score indicates greater stress.

Change in individual resilience as measured by the 25-item Resiliency Scale

时间窗: From Enrollment to end of treatment at 6 weeks

The Resiliency Scale uses a 7-point Likert scale to assess how much a respondent agrees or disagrees with statements. The possible total score ranges from 25 to 175, with higher scores indicating greater resilience. Scores above 145 indicate high resilience, 121 to 145 indicate moderate resilience, and below 120 indicate low resilience.

Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health

时间窗: From Enrollment to end of treatment at 6 weeks

The PROMIS Global Health score ranges from 10 to 50, where a higher score indicates better overall health.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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