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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
817
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Connecticut
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New Haven、Connecticut、アメリカ、05611
- Yale University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
12年～18年 (子、大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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介入なし：Control
Controls wait-listed for the intervention, matched for age and urban residence
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Psychosocial Stress: Insecurity (Regional Measure)
時間枠：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)
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mental Health Difficulties: Regional Measure
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Posttraumatic stress symptoms
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
捜査官
- 主任研究者：catherine panter-brick, PhD、Yale University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年4月1日
一次修了 (実際)
2016年9月1日
研究の完了 (実際)
2017年4月1日
試験登録日
最初に提出
2016年12月21日
QC基準を満たした最初の提出物
2017年1月4日
最初の投稿 (見積もり)
2017年1月6日
学習記録の更新
投稿された最後の更新 (実際)
2021年1月15日
QC基準を満たした最後の更新が送信されました
2021年1月13日
最終確認日
2021年1月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
We are sharing the anonymized dataset with project collaborators, but only with other researchers upon explicit request.
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
ストレス、心理の臨床試験
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Chinese University of Hong Kong積極的、募集していないうつ | 不安 | オンライン セルフヘルプ Transdiagnostic Psychological Intervention香港
Advancing Adolescentsの臨床試験
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Woebot HealthChildren's Hospital of The King's Daughters完了