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临床试验/NCT04785339
NCT04785339撤回不适用

Latinx Acculturative Stress Intervention Development and Implementation (REACH Equity CDA)

Duke University0 个研究点开始时间: 2022年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Acculturative Stress as measured by the Hispanic Stress Inventory-2

研究概览

简要总结

The overarching aim of the study is to garner empirical support for intervention components that can reduce acculturative stress in Latinx immigrants. Informed by our review of the literature and our prior research, we hypothesize that we can target the following mechanisms in a modularized group intervention format, as detailed below. These are preliminary areas targeted by the intervention, but may be updated based on feedback from the Community Advisory Board, Community Consultation Studio, and Duke Health key informants.

详细描述

As health disparities widen for Latinx immigrants, there is an urgent unmet public health need to develop an evidence-based interventions reducing stress experienced by this population that can be easily scalable across diverse clinical settings and geographically distinct immigrant communities. Thus, the purpose of this study is to develop and pilot test a novel group acculturative stress intervention for Latinx immigrants.

Study activities Aim 1: Co-develop an acculturation stress intervention for adult Latinx immigrants to decrease stress, increase resilience, and prevent declines in mental and physical health.

Aim 2: Examine the preliminary clinical impact, feasibility, and acceptability of a group acculturative stress in Latinx immigrants and collect information to inform subsequent implementation.

Aim 2a: Conduct pilot testing of the group intervention in Latinx immigrant participants (N=24-30)to evaluate its preliminary clinical impact from baseline to post-assessment on stress, resilience, and health outcomes (e.g., depression, anxiety, self-rated health).

Aim 2b: Characterize the inner and outer context, facilitators, barriers, intent to adopt, and resources across the Duke University Health System through multiple stakeholder interviews with providers and administrators (n=8-10).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

入选标准

  • 18 years old,
  • Latinx/Hispanic Self identifying
  • Immigrant (born outside of the US)

排除标准

  • Active suicidal ideation (i.e., imminent SI in the last 12 months AND ≥1 suicide attempts in the last 10 years)
  • Unmanaged severe mental illness (i.e., psychotic disorder, manic symptoms, eating disorder, substance use disorder)

结局指标

主要结局

Acculturative Stress as measured by the Hispanic Stress Inventory-2

时间窗: 10 weeks

Hispanic Stress Inventory-2 is 24 item questionnaire asking about stress on a scale of 1 to 5, where 1 is not stressed and 5 is very stressed".

Perceived Stress as measured by the Perceived Stress Scale

时间窗: 10 weeks

The Perceived Stress scale is a 23-item questionnaire asking about stress on a scale of 1 to 5, where 1 is not stressed and 5 is extremely stressed.

Dispositional resilience as measured by the Resiliency Scale

时间窗: 10 weeks

Resilience scale is a 25-item questionnaire asking resilience on a scale of 1 to 7, where 1 is disagree and 7 is strongly agree.

Coping strategies as measured by the Brief COPE Scale

时间窗: 10 weeks

Brief COPE Scale is a 24-item questionnaire asking coping on a scale of 1 to 4, where is not at all and 4 is a lot.

Ethnic Identity as measured by the Multigroup Ethnic Identity Measure

时间窗: 10 weeks

MEI is a 12-item questionnaire asking about Hispanic identity on a scale of 1 to 7, where 1 is strongly disagree and 7 is strongly agree.

Familism as measured by Familism Scale.

时间窗: 10 weeks

Familism Scale is a 15 -item questionnaire asking about family welfare concern on a scale of 1 to 6, where 1 is strongly disagree and 6 is don't know.

Social Support as measured by Social Support Questionnaire

时间窗: 10 weeks

Social Support Questionnaire is 16-item questionnaire asking about social support on a scale of 1 to 5, where 1 is Never and 5 is always.

次要结局

  • Anxiety symptoms as measured by GAD-7(10 weeks)
  • Depression symptoms as measured by PHQ-9(10 weeks)
  • Sleep Disturbance as measured by Sleep Disturbance(10 weeks)
  • Drug Use as measured by Drug Abuse screening Test (DAST)(10 weeks)
  • Self-reported Physical Health as measured by Physical activity.(10 weeks)
  • Self-reported Physical Health as measured by Short Form Health Survey(10 weeks.)
  • Self-reported Physical Health as measured by Self-Rated Health(10 weeks)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

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