<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/NCT03822598</url>
  </required_header>
  <id_info>
    <org_study_id>16/54571</org_study_id>
    <nct_id>NCT03822598</nct_id>
  </id_info>
  <brief_title>Promoting Asylum-seeking and Refugee Children's Coping With Trauma</brief_title>
  <official_title>Implementation and Evaluation of Teaching Recovery Techniques (TRT) Among Asylum-seeking and Refugee Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian Institute of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Tromso</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bergen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian Directorate of Children, Youth, and Family Affairs</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian Directorate of Immigration</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian Directorate of Integration and Diversity</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian Institute of Public Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A short term trauma-focused cognitive- behavioral program to reduce trauma-related mental&#xD;
      health problems among asylum-seeking and refugee children.&#xD;
&#xD;
      The main hypothesis of the study is that the TRT program significantly improves mental health&#xD;
      (i.e. reduces symptoms of post-traumatic symptoms, depression and generalized anxiety and&#xD;
      increases perceived quality of life (Qol) in the intervention group compared to the&#xD;
      waiting-list control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Teaching Recovery Techniques (TRT) was developed by Children and War Foundation&#xD;
      (www.childrenandwarfoundation.org ) as a tool to support children in coping with their mental&#xD;
      reactions to being exposed to war and catastrophes. TRT has proven to be effective in&#xD;
      reducing trauma-related mental health symptoms in such contexts. However, it has never been&#xD;
      used with children experiencing all the uncertainties and stress of an asylum-seeking&#xD;
      context, or with refugee children in high-income countries. The main aim of the present study&#xD;
      is therefore to implement and evaluate the TRT among asylum-seeking and refugee children in&#xD;
      the context of four different care conditions: 1)asylum-seeking children who arrived&#xD;
      accompanied by a legal care-taker 2) asylum-seeking children less than 15 years in care&#xD;
      centers administered by the Child Welfare Services 3) asylum-seeking children 15 years and&#xD;
      older living in asylum centers regulated by the Directorate of Immigration 4) Former&#xD;
      unaccompanied asylum-seeking children who have been granted residence (refugees) and are&#xD;
      resettled in a municipality in Norway.&#xD;
&#xD;
      Based on Power analyses, the target group is 40 children in each care condition (total n =&#xD;
      160) &gt; 9 years speaking Arabic, Tigrinya, Somali, Dari, or Pashto.&#xD;
&#xD;
      The study employs a randomized clustered experimental design that includes a waiting list&#xD;
      control group, which will receive the TRT when the intervention group has completed the&#xD;
      program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 20, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Two stages of recruitment: 1) We recruited asylum reception centers and refugee resettlement municipalities located all over Norway 2) Invite asylum-seeking and refugee children in these institutions to participate, and assigning them by intstitution to control and intervention conditions. The intervention groups started implementing TRT between late September and late October. The control groups started implementing TRT between medio November and beginning of February.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Children's Revised Impact of Event Scale (CRIES-13)</measure>
    <time_frame>Change in CRIES-13 scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.</time_frame>
    <description>Self-reported symptoms of intrusion, hyperarousal and avoidance. ' The participants check how often during the last week they had each symptom from &quot;never&quot; (0); &quot;rarely&quot; (1) &quot;sometimes&quot; (3) and &quot;frequently&quot; (5)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Screen for Child Anxiety Related Disorders (SCARED). 9 items tapping symptoms of generalized anxiety disorder, and 7 items tapping symptoms of social anxiety</measure>
    <time_frame>Change in SCARED-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.</time_frame>
    <description>Measures if children have perceived each anxiety symptom over the last three months from &quot;not true, or hardly ever true&quot; (0), &quot;somewhat true or sometimes true&quot; (1) &quot;very true or often true&quot; (2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cantril Ladder</measure>
    <time_frame>Change in scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.</time_frame>
    <description>Measures current subjective well-being on a ladder With 11 steps from &quot;worst possible life&quot; (0) to &quot;best possible life&quot; (10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montgomery-Aasberg Depression Scale, MADRS</measure>
    <time_frame>Change in MADRS-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.</time_frame>
    <description>9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life over the last three days. Each item is scored between 0 (not a problem for me) and 3 (affects me very much), with three intermediate levels (0.5, 1.5, 2.5).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Mental Health Disorder</condition>
  <condition>Post-Traumatic Stress Disorder in Adolescence</condition>
  <condition>Depression</condition>
  <condition>Social Anxiety</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Teaching Recovery Techniques implemented 1- 3 weeks after recruitment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Delayed implementation of Teaching Recovery Techniques (after the experimental group has completed the program)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Teaching Recovery Techniques, TRT</intervention_name>
    <description>TRT is a , low-threshold, group based, manual driven short term intervention to reduce trauma-related mental health problems. The program is based on principles from trauma-focused cognitive-behavioral therapy</description>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_label>Wait-list control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Accompanied asylum-seeking children living in reception centers,&#xD;
&#xD;
          -  Unaccompanied asylum-seeking children living in reception centers&#xD;
&#xD;
          -  Unaccompanied refugee minors who have been granted residence&#xD;
&#xD;
        Children in the target Groups reported symptoms of post-traumatic stress above clinical&#xD;
        cut-off on Children's Revised Impact of Event Scale, 8 items&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychosis,&#xD;
&#xD;
          -  Mental disabilities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bergen Municipality</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nordre Land municipality</name>
      <address>
        <city>Dokka</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drammen Municipality</name>
      <address>
        <city>Drammen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Engerdal Municipality</name>
      <address>
        <city>Drevsjø</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fredrikstad municipality</name>
      <address>
        <city>Fredrikstad</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gjøvik municipality</name>
      <address>
        <city>Gjøvik</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ringerike Municipality</name>
      <address>
        <city>Hønefoss</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grue municipality</name>
      <address>
        <city>Kirkenær</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levanger municipality</name>
      <address>
        <city>Leira</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyngdal municipality</name>
      <address>
        <city>Lyngdal</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyngdal municipality</name>
      <address>
        <city>Lyng</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bærum municipality</name>
      <address>
        <city>Rud</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salten municipality</name>
      <address>
        <city>Sjøvegan</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stavanger municipality</name>
      <address>
        <city>Stavanger</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trondheim municipality</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vadsø municipality</name>
      <address>
        <city>Vadsø</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Norwegian Institute of Public Health</investigator_affiliation>
    <investigator_full_name>Brit Oppedal</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Teaching Recovery Techniques</keyword>
  <keyword>Asylum-seeking children</keyword>
  <keyword>Refugee children</keyword>
  <keyword>Low-threshold intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>It is not yet known if there will be a plan to make Individual Patient Data (IPD) available. If IPD are to be shared, we follow the regulations of the Norwegian Institute of Public Health</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03822598/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03822598
org study id: 16/54571
nct id: NCT03822598
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A short term trauma-focused cognitive- behavioral program to reduce trauma-related mental
      health problems among asylum-seeking and refugee children.

      The main hypothesis of the study is that the TRT program significantly improves mental health
      (i.e. reduces symptoms of post-traumatic symptoms, depression and generalized anxiety and
      increases perceived quality of life (Qol) in the intervention group compared to the
      waiting-list control group.
Teaching Recovery Techniques (TRT) was developed by Children and War Foundation
      (www.childrenandwarfoundation.org ) as a tool to support children in coping with their mental
      reactions to being exposed to war and catastrophes. TRT has proven to be effective in
      reducing trauma-related mental health symptoms in such contexts. However, it has never been
      used with children experiencing all the uncertainties and stress of an asylum-seeking
      context, or with refugee children in high-income countries. The main aim of the present study
      is therefore to implement and evaluate the TRT among asylum-seeking and refugee children in
      the context of four different care conditions: 1)asylum-seeking children who arrived
      accompanied by a legal care-taker 2) asylum-seeking children less than 15 years in care
      centers administered by the Child Welfare Services 3) asylum-seeking children 15 years and
      older living in asylum centers regulated by the Directorate of Immigration 4) Former
      unaccompanied asylum-seeking children who have been granted residence (refugees) and are
      resettled in a municipality in Norway.

      Based on Power analyses, the target group is 40 children in each care condition (total n =
      160) > 9 years speaking Arabic, Tigrinya, Somali, Dari, or Pashto.

      The study employs a randomized clustered experimental design that includes a waiting list
      control group, which will receive the TRT when the intervention group has completed the
      program.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Two stages of recruitment: 1) We recruited asylum reception centers and refugee resettlement municipalities located all over Norway 2) Invite asylum-seeking and refugee children in these institutions to participate, and assigning them by intstitution to control and intervention conditions. The intervention groups started implementing TRT between late September and late October. The control groups started implementing TRT between medio November and beginning of February.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Children's Revised Impact of Event Scale (CRIES-13)
time frame: Change in CRIES-13 scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
description: Self-reported symptoms of intrusion, hyperarousal and avoidance. ' The participants check how often during the last week they had each symptom from "never" (0); "rarely" (1) "sometimes" (3) and "frequently" (5)
measure: Screen for Child Anxiety Related Disorders (SCARED). 9 items tapping symptoms of generalized anxiety disorder, and 7 items tapping symptoms of social anxiety
time frame: Change in SCARED-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
description: Measures if children have perceived each anxiety symptom over the last three months from "not true, or hardly ever true" (0), "somewhat true or sometimes true" (1) "very true or often true" (2)
measure: Cantril Ladder
time frame: Change in scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
description: Measures current subjective well-being on a ladder With 11 steps from "worst possible life" (0) to "best possible life" (10)
measure: Montgomery-Aasberg Depression Scale, MADRS
time frame: Change in MADRS-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
description: 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life over the last three days. Each item is scored between 0 (not a problem for me) and 3 (affects me very much), with three intermediate levels (0.5, 1.5, 2.5).
arm group label: Intervention group
arm group type: Experimental
description: Teaching Recovery Techniques implemented 1- 3 weeks after recruitment
arm group label: Wait-list control group
arm group type: Active Comparator
description: Delayed implementation of Teaching Recovery Techniques (after the experimental group has completed the program)
intervention type: Behavioral
intervention name: Teaching Recovery Techniques, TRT
description: TRT is a , low-threshold, group based, manual driven short term intervention to reduce trauma-related mental health problems. The program is based on principles from trauma-focused cognitive-behavioral therapy
arm group label: Intervention group
arm group label: Wait-list control group
criteria: 
gender: All
minimum age: 8 Years
maximum age: 20 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Norwegian Institute of Public Health
investigator full name: Brit Oppedal
investigator title: Principal Investigator
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
mesh term: Mental Disorders
sharing ipd: Undecided
ipd description: It is not yet known if there will be a plan to make Individual Patient Data (IPD) available. If IPD are to be shared, we follow the regulations of the Norwegian Institute of Public Health
provided document: 