<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03012451</url>
  </required_header>
  <id_info>
    <org_study_id>1502015359</org_study_id>
    <nct_id>NCT03012451</nct_id>
  </id_info>
  <brief_title>A Psychosocial Program Impact Evaluation in Jordan</brief_title>
  <official_title>Measuring the Health and Wellbeing Impacts of a Scalable Program of Psychosocial Intervention for Refugee Youth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Queen Margaret University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Western Ontario, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to deliver a robust pre-post evaluation of the wellbeing impacts of an&#xD;
      innovative, brief, and scalable psychosocial intervention, delivered to refugee youth living&#xD;
      in urban settlements in Jordan. The study was conducted using two waves of data collection:&#xD;
      the first featured an intervention and a matched control group, the second featured a full&#xD;
      randomized control trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will provide a robust evaluation of the Mercy Corps 'Advancing Adolescents, No&#xD;
      Lost Generation' program that targets stress alleviation in refugee youth (12-18 years) with&#xD;
      specific measures of psychosocial stress, biological stress, and cognitive function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Psychosocial Stress: Insecurity (Regional Measure)</measure>
    <time_frame>11 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychosocial stress: Distress (Regional Measure)</measure>
    <time_frame>11 weeks</time_frame>
    <description>Distress was measured with the Human Distress scale (Hamayel &amp; 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, &quot;To what extent have you felt worried,&quot; &quot;To what extent did you feel humiliated,&quot; and &quot;To what extent did you feel angry.&quot; Scores are presented as percentages (0-100%), with higher scores indicating greater distress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychosocial Stress (International Measure)</measure>
    <time_frame>11 weeks</time_frame>
    <description>Stress was measured using the Arabic version of the Perceived Stress Scale (Cohen, Karmarck, &amp; Mermelstein, 1983), validated with a Jordanian sample (Almadi, Cathers, Hamdan Mansour, &amp; Chow, 2012). This 14-item, 5-point Likert scale measures perceived stress over the last month, with higher scores indicating greater stress. Items include, &quot;How often have you been upset because of something that happened unexpectedly?&quot; and &quot;How often have you been able to control irritations in your life?&quot; (reverse-scored) (1 = Never, 5 = Very often).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mental Health Difficulties: Regional Measure</measure>
    <time_frame>11 weeks</time_frame>
    <description>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, &quot;During the last week I was upset&quot;, &quot;During the last week I was bored and hated my life&quot;, and &quot;During the last week, I was having a lot of headaches, stomach-aches, and nausea&quot; (1 = Rarely, 3 = Always). Higher scores indicate more symptoms of anxiety and depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental Health Difficulties: International Measure</measure>
    <time_frame>11 weeks</time_frame>
    <description>The Arabic version of the Strengths and Difficulties Questionnaire (SDQ), a brief screening tool for psychiatric difficulties (Alyahri &amp; 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 &amp; Goodman, 2006).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosocial Behavior: International Measure</measure>
    <time_frame>11 weeks</time_frame>
    <description>The Strengths and Difficulties Questionnaire (SDQ) Prosocial Score, which featured 5 items to assess prosociality was used. Items include &quot;I try to be nice to other people. I care about their feelings&quot; and &quot;I am helpful if someone is hurt, upset, or feeling sick&quot; (0 = Not true, 2 = Certainly true). Higher scores indicate greater prosociality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resilience: Cross-cultural Measure</measure>
    <time_frame>11 weeks</time_frame>
    <description>Resilience was measured using the CYRM-28 (Liebenberg et al., 2012; Ungar &amp; Liebenberg, 2011), which had been translated and culturally grounded for use into Arabic. Responses ranged from 1 (&quot;Not at all&quot;) to 5 (&quot;A lot&quot;), with higher scores indicating greater resilience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biological Stress: Cortisol</measure>
    <time_frame>11 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biological Stress: Cell-mediated Immune Function</measure>
    <time_frame>11 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>11 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Posttraumatic stress symptoms</measure>
    <time_frame>11 weeks</time_frame>
    <description>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 &gt;17 points is predictive of symptoms of posttraumatic stress disorder (http://www.childrenandwar.org).</description>
  </other_outcome>
  <other_outcome>
    <measure>Genetic markers of trauma and/or stress</measure>
    <time_frame>11 weeks</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">817</enrollment>
  <condition>Stress, Psychological</condition>
  <condition>Mental Health Impairment</condition>
  <arm_group>
    <arm_group_label>Advancing Adolescents</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Received structured eight-week psychosocial sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Controls wait-listed for the intervention, matched for age and urban residence</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Advancing Adolescents</intervention_name>
    <description>The &quot;Advancing Adolescents&quot; 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.</description>
    <arm_group_label>Advancing Adolescents</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible and enrolled in Mercy Corps Advancing Adolescents program&#xD;
&#xD;
          -  Syrian refugee and Jordanian host-community youth residing in 4 urban centers in&#xD;
             northern Jordan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not available for study recruitment (started sessions or deferred sessions before&#xD;
             study start date).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>catherine panter-brick, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>05611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.elrha.org/map-location/yale-psychosocial-call2/</url>
    <description>Save the Children Fund Enhancing Learning and Research for Humanitarian Assistance</description>
  </link>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress</keyword>
  <keyword>Insecurity</keyword>
  <keyword>Mental Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We are sharing the anonymized dataset with project collaborators, but only with other researchers upon explicit request.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03012451
org study id: 1502015359
nct id: NCT03012451
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Psychosocial Stress: Insecurity (Regional Measure)
time frame: 11 weeks
description: 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.
measure: Psychosocial stress: Distress (Regional Measure)
time frame: 11 weeks
description: 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.
measure: Psychosocial Stress (International Measure)
time frame: 11 weeks
description: 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).
measure: Mental Health Difficulties: Regional Measure
time frame: 11 weeks
description: 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.
measure: Mental Health Difficulties: International Measure
time frame: 11 weeks
description: 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).
measure: Prosocial Behavior: International Measure
time frame: 11 weeks
description: 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.
measure: Resilience: Cross-cultural Measure
time frame: 11 weeks
description: 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.
measure: Biological Stress: Cortisol
time frame: 11 weeks
description: 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.
measure: Biological Stress: Cell-mediated Immune Function
time frame: 11 weeks
description: 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.
measure: Cognitive function
time frame: 11 weeks
description: 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.
measure: Posttraumatic stress symptoms
time frame: 11 weeks
description: 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).
measure: Genetic markers of trauma and/or stress
time frame: 11 weeks
description: 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.
arm group label: Advancing Adolescents
arm group type: Experimental
description: Received structured eight-week psychosocial sessions
arm group label: Control
arm group type: No Intervention
description: Controls wait-listed for the intervention, matched for age and urban residence
intervention type: Behavioral
intervention name: Advancing Adolescents
description: 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.
arm group label: Advancing Adolescents
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: catherine panter-brick, PhD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
url: http://www.elrha.org/map-location/yale-psychosocial-call2/
description: Save the Children Fund Enhancing Learning and Research for Humanitarian Assistance
responsible party type: Sponsor
mesh term: Stress, Psychological
sharing ipd: No
ipd description: We are sharing the anonymized dataset with project collaborators, but only with other researchers upon explicit request.