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A Psychosocial Program Impact Evaluation in Jordan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03012451
Recruitment Status : Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : January 9, 2020
Sponsor:
Collaborators:
Queen Margaret University
University of Western Ontario, Canada
Harvard University
University of Florida
Information provided by (Responsible Party):
Yale University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stress, Psychological Mental Health Impairment Behavioral: Advancing Adolescents Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 817 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Measuring the Health and Wellbeing Impacts of a Scalable Program of Psychosocial Intervention for Refugee Youth
Study Start Date : April 2015
Actual Primary Completion Date : September 2016
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: Advancing Adolescents
Received structured eight-week psychosocial sessions
Behavioral: Advancing Adolescents
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.

No Intervention: Control
Controls wait-listed for the intervention, matched for age and urban residence



Primary Outcome Measures :
  1. Psychosocial Stress: Insecurity (Regional Measure) [ Time Frame: 11 weeks ]
    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.

  2. Psychosocial stress: Distress (Regional Measure) [ Time Frame: 11 weeks ]
    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.

  3. Psychosocial Stress (International Measure) [ Time Frame: 11 weeks ]
    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).


Secondary Outcome Measures :
  1. Mental Health Difficulties: Regional Measure [ Time Frame: 11 weeks ]
    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.

  2. Mental Health Difficulties: International Measure [ Time Frame: 11 weeks ]
    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).

  3. Prosocial Behavior: International Measure [ Time Frame: 11 weeks ]
    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.

  4. Resilience: Cross-cultural Measure [ Time Frame: 11 weeks ]
    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.

  5. Biological Stress: Cortisol [ Time Frame: 11 weeks ]
    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.

  6. Biological Stress: Cell-mediated Immune Function [ Time Frame: 11 weeks ]
    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.

  7. Cognitive function [ Time Frame: 11 weeks ]
    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.


Other Outcome Measures:
  1. Posttraumatic stress symptoms [ Time Frame: 11 weeks ]
    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).

  2. Genetic markers of trauma and/or stress [ Time Frame: 11 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012451


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 05611
Sponsors and Collaborators
Yale University
Queen Margaret University
University of Western Ontario, Canada
Harvard University
University of Florida
Investigators
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Principal Investigator: catherine panter-brick, PhD Yale University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03012451    
Other Study ID Numbers: 1502015359
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are sharing the anonymized dataset with project collaborators, but only with other researchers upon explicit request.
Keywords provided by Yale University:
Stress
Insecurity
Mental Health
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms