<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/NCT03760627</url>
  </required_header>
  <id_info>
    <org_study_id>2000024279</org_study_id>
    <nct_id>NCT03760627</nct_id>
  </id_info>
  <brief_title>Evaluation of A Mindfulness Resiliency Training Program for Refugees Living in Jordan</brief_title>
  <official_title>Evaluation of A Mindfulness Resiliency Training Program for Refugees Living in Jordan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To estimate the efficacy of a structured, scalable and replicable psychosocial intervention&#xD;
      targeting refugees living in Jordan, Amman who have been forced to flee their homes due to&#xD;
      regional conflicts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed to examine the effects of the Mindfulness Resiliency Training Program&#xD;
      (MRTP) conducted at Collateral Repair Project (CRP) on the resilience of refugees. The study&#xD;
      group and the control group will be recruited from refugees currently residing in Amman,&#xD;
      Jordan who are participating in the MRTP at CRP, an ongoing program independent of our study.&#xD;
&#xD;
      In order to assess the effect of the MRTP on participant resiliency, the three survey tools&#xD;
      described above will be used:&#xD;
&#xD;
        1. the Strength and Difficulties Questionnaire (SDQ) as a measure of the individual's&#xD;
           degree of traumatization and&#xD;
&#xD;
        2. the Child and Youth Resiliency Measure (CYRM-12) (for adolescents) or the Adult&#xD;
           Resiliency Measure (ARM-12) (for adults) as a measure of resiliency&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 2020</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>Crossover Assignment</intervention_model>
    <intervention_model_description>This is a stepped wedge cluster randomized trial design. The design involves random and sequential crossover of clusters from control to intervention until all clusters are exposed. The controls from the previous session who were available for the parallel portion of the study, will later become the treatment group while another control group is recruited for them, which in turn will become an intervention group and so forth.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess Mindfulness Resiliency Adolescents</measure>
    <time_frame>2 months</time_frame>
    <description>In order to assess the effect of the Mindfulness Resiliency Training Program (MRTP) on participant resiliency, the Child and Youth Resiliency Measurement (CYRM-12) 12 question assessment tool for adolescents will be used to measure an increase in scores from baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess Mindfulness Resiliency Adolescents</measure>
    <time_frame>6 months</time_frame>
    <description>In order to assess the effect of the MRTP on participant resiliency, the CYRM-12 for adolescents will be used to measure an increase in scores from baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess Mindfulness Resiliency Adults</measure>
    <time_frame>2 months</time_frame>
    <description>In order to assess the effect of the MRTP on participant resiliency, the Adult Resiliency Measurement 12 question assessment tool (ARM-12) will be used to measure an improvement in score from pre-intervention baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess Mindfulness Resiliency Adults</measure>
    <time_frame>6 months</time_frame>
    <description>In order to assess the effect of the MRTP on participant resiliency, the Adult Resiliency Measurement tool (ARM-12) will be used to measure an improvement in score from pre-intervention baseline.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)</condition>
  <condition>Mental Health Wellness 1</condition>
  <condition>War-Related Trauma</condition>
  <arm_group>
    <arm_group_label>Refugees Mindfulness Resiliency Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Collateral Repair Project (CRP) will conduct a Mindfulness Resiliency Training Program (MRTP) for refugees residing in Amman, Jordan. A small support group will demonstrate to participants techniques that they can use to self-manage their own stress and trauma.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control group will receive the training after the study group at 2 months and the control group will then become the study group for the new session. A new group of 20 participants will be recruited who will act as a control for that session. The surveys from the control group will be compared with the study group at 0 and 2 months. Each session will last for two months. The control group will receive the training at the end of the two months. This process will be repeated for a total of nine sessions over a total period of 12 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Refugees Mindfulness Resiliency Training</intervention_name>
    <description>The intervention consists of meditation, guided imagery, yoga and exercise, biofeedback; self-expression in words, drawings, and movement; and small group support to demonstrate to participants techniques that they can use to self-manage their own stress and trauma.</description>
    <arm_group_label>Refugees Mindfulness Resiliency Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Resiliency Training</intervention_name>
    <description>The intervention consists of meditation, guided imagery, yoga and exercise, biofeedback; self-expression in words, drawings, and movement; and small group support to demonstrate to participants techniques that they can use to self-manage their own stress and trauma.</description>
    <arm_group_label>Control arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who will be recruited in the study are adult and adolescent (13-19 years)&#xD;
             refugees, Syrian and non-Syrians, who are currently residing in Amman, Jordan who will&#xD;
             be participating in the MRTP at CRP.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Jordanian refugees residing in Amman, Jordan.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saquib Lakhani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Prachi Syngal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Collateral repair Project</name>
      <address>
        <city>Amman</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>October 19, 2021</last_update_submitted>
  <last_update_submitted_qc>October 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>War-Related Injuries</mesh_term>
    <mesh_term>Personality Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT03760627
org study id: 2000024279
nct id: NCT03760627
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To estimate the efficacy of a structured, scalable and replicable psychosocial intervention
      targeting refugees living in Jordan, Amman who have been forced to flee their homes due to
      regional conflicts.
The study is designed to examine the effects of the Mindfulness Resiliency Training Program
      (MRTP) conducted at Collateral Repair Project (CRP) on the resilience of refugees. The study
      group and the control group will be recruited from refugees currently residing in Amman,
      Jordan who are participating in the MRTP at CRP, an ongoing program independent of our study.

      In order to assess the effect of the MRTP on participant resiliency, the three survey tools
      described above will be used:

        1. the Strength and Difficulties Questionnaire (SDQ) as a measure of the individual's
           degree of traumatization and

        2. the Child and Youth Resiliency Measure (CYRM-12) (for adolescents) or the Adult
           Resiliency Measure (ARM-12) (for adults) as a measure of resiliency
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This is a stepped wedge cluster randomized trial design. The design involves random and sequential crossover of clusters from control to intervention until all clusters are exposed. The controls from the previous session who were available for the parallel portion of the study, will later become the treatment group while another control group is recruited for them, which in turn will become an intervention group and so forth.
primary purpose: Supportive Care
masking: Single (Participant)
measure: Assess Mindfulness Resiliency Adolescents
time frame: 2 months
description: In order to assess the effect of the Mindfulness Resiliency Training Program (MRTP) on participant resiliency, the Child and Youth Resiliency Measurement (CYRM-12) 12 question assessment tool for adolescents will be used to measure an increase in scores from baseline.
measure: Assess Mindfulness Resiliency Adolescents
time frame: 6 months
description: In order to assess the effect of the MRTP on participant resiliency, the CYRM-12 for adolescents will be used to measure an increase in scores from baseline.
measure: Assess Mindfulness Resiliency Adults
time frame: 2 months
description: In order to assess the effect of the MRTP on participant resiliency, the Adult Resiliency Measurement 12 question assessment tool (ARM-12) will be used to measure an improvement in score from pre-intervention baseline.
measure: Assess Mindfulness Resiliency Adults
time frame: 6 months
description: In order to assess the effect of the MRTP on participant resiliency, the Adult Resiliency Measurement tool (ARM-12) will be used to measure an improvement in score from pre-intervention baseline.
arm group label: Refugees Mindfulness Resiliency Training
arm group type: Experimental
description: The Collateral Repair Project (CRP) will conduct a Mindfulness Resiliency Training Program (MRTP) for refugees residing in Amman, Jordan. A small support group will demonstrate to participants techniques that they can use to self-manage their own stress and trauma.
arm group label: Control arm
arm group type: Placebo Comparator
description: The control group will receive the training after the study group at 2 months and the control group will then become the study group for the new session. A new group of 20 participants will be recruited who will act as a control for that session. The surveys from the control group will be compared with the study group at 0 and 2 months. Each session will last for two months. The control group will receive the training at the end of the two months. This process will be repeated for a total of nine sessions over a total period of 12 months.
intervention type: Behavioral
intervention name: Refugees Mindfulness Resiliency Training
description: The intervention consists of meditation, guided imagery, yoga and exercise, biofeedback; self-expression in words, drawings, and movement; and small group support to demonstrate to participants techniques that they can use to self-manage their own stress and trauma.
arm group label: Refugees Mindfulness Resiliency Training
intervention type: Behavioral
intervention name: Mindfulness Resiliency Training
description: The intervention consists of meditation, guided imagery, yoga and exercise, biofeedback; self-expression in words, drawings, and movement; and small group support to demonstrate to participants techniques that they can use to self-manage their own stress and trauma.
arm group label: Control arm
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Saquib Lakhani, MD
role: Principal Investigator
affiliation: Yale University
last name: Prachi Syngal, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: Jordan
responsible party type: Sponsor
mesh term: Substance-Related Disorders
mesh term: War-Related Injuries
mesh term: Personality Disorders