<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/NCT02220179</url>
  </required_header>
  <id_info>
    <org_study_id>DK-res-care</org_study_id>
    <nct_id>NCT02220179</nct_id>
  </id_info>
  <brief_title>Resilience for Children and Young People in Foster Care and Residential Care in Denmark</brief_title>
  <official_title>Resilience for Children and Young People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poul Bak</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TRYG Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this project we invite 9.000 children and young persons in Denmark and their foster&#xD;
      parents and staff at the residential institutions to participate in a cluster randomized&#xD;
      controlled intervention study where we aim to test the effectiveness of a web based knowledge&#xD;
      and inspiration program about resilience for children, adolescents and adults (called&#xD;
      myresilience.org). The complete CONSORT trial protocol is available at&#xD;
      http://myresilience.org/ at the subsite 'about us'.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite&#xD;
      'about us'.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</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>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>National Test in Danish Reading</measure>
    <time_frame>Outcome data will be collected on the average 2 years after intervention</time_frame>
    <description>The National test in danish reading is a standard performance test which is mandatory for all danish student. It is administered for every other year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The frequency of Care collapse</measure>
    <time_frame>Outcome data will be collected on the average 2 years after intervention</time_frame>
    <description>All incidents of collapse in a care relation is registered by the danish authorities. The informations in this register are used for this outcome measure.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Questionnaire data</measure>
    <time_frame>data collected august 2015</time_frame>
    <description>Se the trial CONSORT protocol at http://myresilience.org/ at the subsite 'about us'</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">9000</enrollment>
  <condition>Children and Adolescents in Foster Care and Residential Care</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>service as usual</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are offered access to the web based resilience program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are offered access to the web based resilience program and are also invited to join a short introduction course about the program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Resilience Program</intervention_name>
    <description>Se the CONSORT trial protocol at http://myresilience.org/ at the subsite 'about us'</description>
    <arm_group_label>Intervention group 1</arm_group_label>
    <arm_group_label>Intervention group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All children and adolescents registered in foster care in Denmark on august 11th 2014.&#xD;
&#xD;
          -  All children and adolescents registered in residential care in Denmark on august 11th&#xD;
             2014.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Request for legal protection against contacts from researchers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>23 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Poul L Bak, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aarhus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>http://myresilience.org/</url>
    <description>Find the CONSORT trial protocol on the subsite 'about us'</description>
  </link>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>June 1, 2015</last_update_submitted>
  <last_update_submitted_qc>June 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Aarhus</investigator_affiliation>
    <investigator_full_name>Poul Bak</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <!-- 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/NCT02220179
org study id: DK-res-care
nct id: NCT02220179
lead sponsor: 
collaborator: 
has dmc: No
In this project we invite 9.000 children and young persons in Denmark and their foster
      parents and staff at the residential institutions to participate in a cluster randomized
      controlled intervention study where we aim to test the effectiveness of a web based knowledge
      and inspiration program about resilience for children, adolescents and adults (called
      myresilience.org). The complete CONSORT trial protocol is available at
      http://myresilience.org/ at the subsite 'about us'.
The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite
      'about us'.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: National Test in Danish Reading
time frame: Outcome data will be collected on the average 2 years after intervention
description: The National test in danish reading is a standard performance test which is mandatory for all danish student. It is administered for every other year.
measure: The frequency of Care collapse
time frame: Outcome data will be collected on the average 2 years after intervention
description: All incidents of collapse in a care relation is registered by the danish authorities. The informations in this register are used for this outcome measure.
measure: Questionnaire data
time frame: data collected august 2015
description: Se the trial CONSORT protocol at http://myresilience.org/ at the subsite 'about us'
arm group label: control
arm group type: No Intervention
description: service as usual
arm group label: Intervention group 1
arm group type: Experimental
description: Participants are offered access to the web based resilience program
arm group label: Intervention group 2
arm group type: Experimental
description: Participants are offered access to the web based resilience program and are also invited to join a short introduction course about the program
intervention type: Behavioral
intervention name: The Resilience Program
description: Se the CONSORT trial protocol at http://myresilience.org/ at the subsite 'about us'
arm group label: Intervention group 1
arm group label: Intervention group 2
criteria: 
gender: All
minimum age: N/A
maximum age: 23 Years
healthy volunteers: No
last name: Poul L Bak, MD
role: Principal Investigator
affiliation: University of Aarhus
facility: 
country: Denmark
url: http://myresilience.org/
description: Find the CONSORT trial protocol on the subsite 'about us'
responsible party type: Sponsor-Investigator
investigator affiliation: University of Aarhus
investigator full name: Poul Bak
investigator title: MD