<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/NCT02220140</url>
  </required_header>
  <id_info>
    <org_study_id>DK-res-adhd</org_study_id>
    <nct_id>NCT02220140</nct_id>
  </id_info>
  <brief_title>Resilience for Young People With ADHD - a Randomized Controlled Trial of a Brief Intervention Program.</brief_title>
  <official_title>Resilience for Young People With Attention Deficit Hyperactivity Disorder (ADHD) - a Randomized Controlled Trial of a Brief Intervention Program.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</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 8.000 young persons (age 18-27) in Denmark and to participate in a&#xD;
      randomized controlled intervention study where we aim to test the effectiveness of a web&#xD;
      based knowledge and inspiration program about resilience for children, adolescents and adults&#xD;
      (called 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">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adult ADHD Self-Report Scale (ASRS-v1.1)</measure>
    <time_frame>Follow-up will be on the average 1 year after intervention</time_frame>
    <description>The Symptom Checklist is an instrument consisting of the eighteen Diagnostic and Statistical Manual criteria (DSM-IV). Six of the eighteen questions were found to be the most predictive of symptoms consistent with ADHD. These six questions are the basis for the ASRS v1.1. The measure is a number score.&#xD;
The ASRS-v1.1 will be administered to all participants before and 1 year after the intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The 12-item General Health Questionnaire (GHQ-12)</measure>
    <time_frame>Follow-up will be on the average 1 year after intervention</time_frame>
    <description>The GHQ-12 is a widely used standard Health Questionnaire. The GHQ-12 will be administered to all participants before and 1 year after the intervention.&#xD;
The measure is a number score.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Youth education attrition</measure>
    <time_frame>December 2016</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">8000</enrollment>
  <condition>ADHD</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</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are offered access to the web based resilience program and are invited to join a short introduction course.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Resilience Program</intervention_name>
    <description>See the CONSORT trial protocol at http://myresilience.org/ at the subsite 'about us'.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A random sample with 8.000 patients registered in the Danish National Patient Register:&#xD;
&#xD;
          -  Age 18-27&#xD;
&#xD;
          -  ADHD diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Request for legal protection against contacts from researchers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>27 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Poul L Bak</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aarhus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University</name>
      <address>
        <city>Aarhus</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>http://myresilience.org/</url>
    <description>See the CONSORT trial protocol at the subsite 'about us'</description>
  </link>
  <verification_date>May 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</responsible_party_type>
  </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/NCT02220140
org study id: DK-res-adhd
nct id: NCT02220140
lead sponsor: 
collaborator: 
has dmc: No
In this project we invite 8.000 young persons (age 18-27) in Denmark and to participate in a
      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: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Adult ADHD Self-Report Scale (ASRS-v1.1)
time frame: Follow-up will be on the average 1 year after intervention
description: The Symptom Checklist is an instrument consisting of the eighteen Diagnostic and Statistical Manual criteria (DSM-IV). Six of the eighteen questions were found to be the most predictive of symptoms consistent with ADHD. These six questions are the basis for the ASRS v1.1. The measure is a number score.
The ASRS-v1.1 will be administered to all participants before and 1 year after the intervention.
measure: The 12-item General Health Questionnaire (GHQ-12)
time frame: Follow-up will be on the average 1 year after intervention
description: The GHQ-12 is a widely used standard Health Questionnaire. The GHQ-12 will be administered to all participants before and 1 year after the intervention.
The measure is a number score.
measure: Youth education attrition
time frame: December 2016
arm group label: Control
arm group type: No Intervention
description: Service as usual
arm group label: Intervention group
arm group type: Experimental
description: Participants are offered access to the web based resilience program and are invited to join a short introduction course.
intervention type: Behavioral
intervention name: The Resilience Program
description: See the CONSORT trial protocol at http://myresilience.org/ at the subsite 'about us'.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 27 Years
healthy volunteers: No
last name: Poul L Bak
role: Principal Investigator
affiliation: University of Aarhus
facility: 
country: Denmark
url: http://myresilience.org/
description: See the CONSORT trial protocol at the subsite 'about us'
responsible party type: Sponsor