<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/NCT02218996</url>
  </required_header>
  <id_info>
    <org_study_id>ID416</org_study_id>
    <nct_id>NCT02218996</nct_id>
  </id_info>
  <brief_title>Treatment of Anxiety Disorders for Children and Adolescents in Regular Outpatient Clinics</brief_title>
  <acronym>TADCAROC</acronym>
  <official_title>Treatment of Anxiety Disorders for Children and Adolescents in Regular Outpatient Clinics (TADCAROC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Helse Vest</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helse Stavanger HF</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the content of the treatment being delivered for&#xD;
      anxiety disorders for children and adolescents in the regular outpatient clinics in western&#xD;
      Norway. The study will also collect data before and after treatment to evaluate the result of&#xD;
      the treatment. Furthermore, as part of the study we aim to collect normative data on two&#xD;
      questionnaires used to identify anxiety symptoms and the extent to which anxiety interfere&#xD;
      with daily functioning. We also aim to develop a quality indicator for anxiety treatment that&#xD;
      can be used to monitor treatment in the regular outpatient service, based on the results of&#xD;
      the current study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Anticipated">December 31, 2029</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2028</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The Anxiety Disorder Interview Schedule for Diagnostic and Statistical Manual (DSM-IV), child and parent versions (ADIS- C/P; Silverman &amp; Albano, 1996).</measure>
    <time_frame>The primary outcome measure will be administered pre-treatment, post treatment (an expected average of 20 weeks) and at ten year follow-up.</time_frame>
    <description>Diagnostic interview for anxiety disorders and other comorbid disorders. For the 10-year follow-up we anticipate to use another version of the diagnostic interview schedule based on revised diagnostic criteria for anxiety disorders.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Children's Anxiety Life Interference Scale (CALIS; Lyneham et al., 2013)</measure>
    <time_frame>This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Screen for Child Anxiety Related Emotional Disorders (SCARED; Birmaher et al., 1999).</measure>
    <time_frame>This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spence Children's Anxiety Scale (SCAS; Spence, 1998)</measure>
    <time_frame>This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)</measure>
    <time_frame>This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Mood &amp; Feeling Questionaire (SMFQ; Angold et al., 1995).</measure>
    <time_frame>This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impressions (CGI; Guy, 1976).</measure>
    <time_frame>The outcome measure will be administered pre-treatment, post treatment (an expected average of 20 weeks) and at ten year follow-up.</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Anxiety Disorders</condition>
  <arm_group>
    <arm_group_label>Psychosocial treatment</arm_group_label>
    <description>Children and adolescents with anxiety disorders</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Psychosocial treatment</intervention_name>
    <description>Regular psychosocial treatment in clinical outpatient service.</description>
    <arm_group_label>Psychosocial treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children/adolescents from 7-17 years old referred to ordinary outpatient mental health&#xD;
        service.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of an anxiety disorder (including PTSD and OCD) based on the&#xD;
             diagnostic interview ADIS (ADIS-C/P; Silverman &amp; Albano, 1996).&#xD;
&#xD;
          -  The anxiety disorder is the patients primary diagnosis.&#xD;
&#xD;
          -  Informed concent is given.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient is in need for other primary treatment intervention (e.g., psychosis,&#xD;
             suicidality risk)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jon F Bjaastad, D. Psych</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Psychiatry, Stavanger University Hospital, N-4068 Stavanger, Norway</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BUPA Helse Stavanger</name>
      <address>
        <city>Stavanger</city>
        <state>Rogaland</state>
        <zip>4011</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <keyword>Children</keyword>
  <keyword>Adolescent</keyword>
  <keyword>Effectiveness</keyword>
  <keyword>Outpatient</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02218996
org study id: ID416
nct id: NCT02218996
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to examine the content of the treatment being delivered for
      anxiety disorders for children and adolescents in the regular outpatient clinics in western
      Norway. The study will also collect data before and after treatment to evaluate the result of
      the treatment. Furthermore, as part of the study we aim to collect normative data on two
      questionnaires used to identify anxiety symptoms and the extent to which anxiety interfere
      with daily functioning. We also aim to develop a quality indicator for anxiety treatment that
      can be used to monitor treatment in the regular outpatient service, based on the results of
      the current study.
observational model: Case-Control
time perspective: Prospective
measure: The Anxiety Disorder Interview Schedule for Diagnostic and Statistical Manual (DSM-IV), child and parent versions (ADIS- C/P; Silverman & Albano, 1996).
time frame: The primary outcome measure will be administered pre-treatment, post treatment (an expected average of 20 weeks) and at ten year follow-up.
description: Diagnostic interview for anxiety disorders and other comorbid disorders. For the 10-year follow-up we anticipate to use another version of the diagnostic interview schedule based on revised diagnostic criteria for anxiety disorders.
measure: Children's Anxiety Life Interference Scale (CALIS; Lyneham et al., 2013)
time frame: This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
measure: The Screen for Child Anxiety Related Emotional Disorders (SCARED; Birmaher et al., 1999).
time frame: This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
measure: Spence Children's Anxiety Scale (SCAS; Spence, 1998)
time frame: This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
measure: The Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)
time frame: This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks)
measure: Short Mood & Feeling Questionaire (SMFQ; Angold et al., 1995).
time frame: This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks)
measure: Clinical Global Impressions (CGI; Guy, 1976).
time frame: The outcome measure will be administered pre-treatment, post treatment (an expected average of 20 weeks) and at ten year follow-up.
arm group label: Psychosocial treatment
description: Children and adolescents with anxiety disorders
intervention type: Other
intervention name: Psychosocial treatment
description: Regular psychosocial treatment in clinical outpatient service.
arm group label: Psychosocial treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: No
last name: Jon F Bjaastad, D. Psych
role: Principal Investigator
affiliation: Division of Psychiatry, Stavanger University Hospital, N-4068 Stavanger, Norway
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Anxiety Disorders
sharing ipd: No