- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03012451
A Psychosocial Program Impact Evaluation in Jordan
2021년 1월 13일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
817
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Connecticut
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New Haven, Connecticut, 미국, 05611
- Yale University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
12년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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간섭 없음: Control
Controls wait-listed for the intervention, matched for age and urban residence
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Psychosocial Stress: Insecurity (Regional Measure)
기간: 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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mental Health Difficulties: Regional Measure
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Posttraumatic stress symptoms
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
협력자
수사관
- 수석 연구원: catherine panter-brick, PhD, Yale University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 4월 1일
기본 완료 (실제)
2016년 9월 1일
연구 완료 (실제)
2017년 4월 1일
연구 등록 날짜
최초 제출
2016년 12월 21일
QC 기준을 충족하는 최초 제출
2017년 1월 4일
처음 게시됨 (추정)
2017년 1월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 1월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 1월 13일
마지막으로 확인됨
2021년 1월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
We are sharing the anonymized dataset with project collaborators, but only with other researchers upon explicit request.
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
스트레스, 심리적에 대한 임상 시험
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Goethe UniversityLudwig-Maximilians - University of Munich완전한
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Istituto Auxologico ItalianoUniversity of Bergen; Catholic University of the Sacred Heart; University of Liege; University... 그리고 다른 협력자들완전한우울증 | 불안 장애 | 스트레스 | 사회적 격리 | Covid-19 Pandemic Psychological 영향이탈리아
Advancing Adolescents에 대한 임상 시험
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Urban InstituteRubicon Programs알려지지 않은