A Psychosocial Program Impact Evaluation in Jordan
2021年1月13日 更新者：Yale University
Measuring the Health and Wellbeing Impacts of a Scalable Program of Psychosocial Intervention for Refugee Youth
The study aims to deliver a robust pre-post evaluation of the wellbeing impacts of an innovative, brief, and scalable psychosocial intervention, delivered to refugee youth living in urban settlements in Jordan.
The study was conducted using two waves of data collection: the first featured an intervention and a matched control group, the second featured a full randomized control trial.
研究概览
详细说明
This study will provide a robust evaluation of the Mercy Corps 'Advancing Adolescents, No Lost Generation' program that targets stress alleviation in refugee youth (12-18 years) with specific measures of psychosocial stress, biological stress, and cognitive function.
研究类型
介入性
注册 (实际的)
817
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Connecticut
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New Haven、Connecticut、美国、05611
- Yale University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
12年 至 18年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Eligible and enrolled in Mercy Corps Advancing Adolescents program
- Syrian refugee and Jordanian host-community youth residing in 4 urban centers in northern Jordan
Exclusion Criteria:
- Not available for study recruitment (started sessions or deferred sessions before study start date).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Advancing Adolescents
Received structured eight-week psychosocial sessions
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The "Advancing Adolescents" programme is a structured 8-week psychosocial intervention for adolescents in humanitarian crises, based on profound stress attunement processes.
It features three elements that are widely viewed as important to support youth adjustment in contexts of complex emergencies: (i) safety: establishment of a 'safe space' within the community as a base for activities and site of protection; (ii) support: facilitation of social support and self-expression; and (iii) structured activities: access to scheduled group activities.
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无干预：Control
Controls wait-listed for the intervention, matched for age and urban residence
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Psychosocial Stress: Insecurity (Regional Measure)
大体时间：11 weeks
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Insecurity was measured with The Human Insecurity (HI).
This tool was developed for use in the West Bank (Ziadni, Hammoudeh et al. 2011, Hamayel, Ghandour et al. 2014).
The 10-item scale is a 5-point Likert scale with scores expressed as percentages on a scale of 0-100.
The HI covers issues such as worries regarding inability to obtain daily life necessities, losing a source of income, fears about the future, and family safety.
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11 weeks
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Psychosocial stress: Distress (Regional Measure)
大体时间：11 weeks
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Distress was measured with the Human Distress scale (Hamayel & Ghandour, 2014), developed for use with conflict-affected adolescents in the West Bank.
The 12-item scale is a 5-point Likert scale with scores expressed as percentages on a scale of 0-100.
Sample items include, "To what extent have you felt worried," "To what extent did you feel humiliated," and "To what extent did you feel angry."
Scores are presented as percentages (0-100%), with higher scores indicating greater distress.
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11 weeks
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Psychosocial Stress (International Measure)
大体时间：11 weeks
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Stress was measured using the Arabic version of the Perceived Stress Scale (Cohen, Karmarck, & Mermelstein, 1983), validated with a Jordanian sample (Almadi, Cathers, Hamdan Mansour, & Chow, 2012).
This 14-item, 5-point Likert scale measures perceived stress over the last month, with higher scores indicating greater stress.
Items include, "How often have you been upset because of something that happened unexpectedly?"
and "How often have you been able to control irritations in your life?" (reverse-scored) (1 = Never, 5 = Very often).
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11 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mental Health Difficulties: Regional Measure
大体时间：11 weeks
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Mental health was assessed using the 21-item Arab Youth Mental Health questionnaire (Mahfoud et al., 2011; Mahkoul et al., 2011).
This measure includes questions such as, "During the last week I was upset", "During the last week I was bored and hated my life", and "During the last week, I was having a lot of headaches, stomach-aches, and nausea" (1 = Rarely, 3 = Always).
Higher scores indicate more symptoms of anxiety and depression.
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11 weeks
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Mental Health Difficulties: International Measure
大体时间：11 weeks
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The Arabic version of the Strengths and Difficulties Questionnaire (SDQ), a brief screening tool for psychiatric difficulties (Alyahri & Goodman, 2006) was used.
The 20 items include emotional, conduct, and hyperactivity symptom scores (range 0-40).
We summed score of the Arabic version of the SDQ subscales relating to hyperactivity, emotional symptoms, conduct problems, and peer problems (Alyahri & Goodman, 2006).
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11 weeks
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Prosocial Behavior: International Measure
大体时间：11 weeks
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The Strengths and Difficulties Questionnaire (SDQ) Prosocial Score, which featured 5 items to assess prosociality was used.
Items include "I try to be nice to other people.
I care about their feelings" and "I am helpful if someone is hurt, upset, or feeling sick" (0 = Not true, 2 = Certainly true).
Higher scores indicate greater prosociality.
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11 weeks
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Resilience: Cross-cultural Measure
大体时间：11 weeks
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Resilience was measured using the CYRM-28 (Liebenberg et al., 2012; Ungar & Liebenberg, 2011), which had been translated and culturally grounded for use into Arabic.
Responses ranged from 1 ("Not at all") to 5 ("A lot"), with higher scores indicating greater resilience.
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11 weeks
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Biological Stress: Cortisol
大体时间：11 weeks
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Cortisol was obtained from immunoassays of scalp hair cortisol that provide useful measures of the altered activity of the hypothalamic-pituitary-adrenal axis.
Scalp hair is collected non-invasively (~100 strands, 0.5 cm area).
This measure indicates chronic stress over the last month, and examined per individual for pre/post intervention levels.
These analyses are being undertaken by Professor van Uum at Western Ontario University.
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11 weeks
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Biological Stress: Cell-mediated Immune Function
大体时间：11 weeks
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Cell-mediated immune function was measured in field settings, using systemic suppression of immune function in response to chronic stress is measured via immunoassays for Epstein Barr Virus antibodies, in conjunction with C-Reactive Protein, from dried blood spots collected from pricking the finger with a sterile disposable lancet.
Three drops of blood on filter paper are dried at room temperature, then frozen until lab assay.
This measure reflects compromised immune response due to psychosocial stress over the past week, and examined per individual for pre/post intervention levels.
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11 weeks
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Cognitive function
大体时间：11 weeks
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Cognitive function was assessed using tablet-based cognitive skill tasks, testing hippocampal function (long term memory) and prefrontal executive function.
Children play short games (1-4 min each) during which they press the tablet in response to geometric shapes.
Responses during game play are recorded and used to measure cognitive function.
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11 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Posttraumatic stress symptoms
大体时间：11 weeks
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The Arabic version of the Child Revised Impact of Events Scale (CRIES-8, 4-point scale) was implemented to assess posttraumatic stress symptoms.
Analysis will be on dimensional scores, noting that CRIES >17 points is predictive of symptoms of posttraumatic stress disorder (http://www.childrenandwar.org).
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11 weeks
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Genetic markers of trauma and/or stress
大体时间：11 weeks
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Genetic and epigenetic analyses in DNA will be undertaken from cheek swab samples to investigate the biological signatures of altered expressions of trauma and/or psychosocial stress.
Whole-genome amplification of the extracted DNA will be used to generate maximum genetic data from the samples.
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11 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：catherine panter-brick, PhD、Yale University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年4月1日
初级完成 (实际的)
2016年9月1日
研究完成 (实际的)
2017年4月1日
研究注册日期
首次提交
2016年12月21日
首先提交符合 QC 标准的
2017年1月4日
首次发布 (估计)
2017年1月6日
研究记录更新
最后更新发布 (实际的)
2021年1月15日
上次提交的符合 QC 标准的更新
2021年1月13日
最后验证
2021年1月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
We are sharing the anonymized dataset with project collaborators, but only with other researchers upon explicit request.
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Advancing Adolescents的临床试验
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Woebot HealthChildren's Hospital of The King's Daughters完全的
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Zealand University HospitalUniversity of Copenhagen; Steno Diabetes Center Copenhagen; Holbaek Sygehus招聘中