<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/NCT02190370</url>
  </required_header>
  <id_info>
    <org_study_id>THICS-Study 3</org_study_id>
    <nct_id>NCT02190370</nct_id>
  </id_info>
  <brief_title>Efficacy of a Resources Activation Treatment on Tic-symptoms</brief_title>
  <official_title>Within Subject Design on the Efficacy of a Resources Activation Treatment Programme in Children and Adolescents With Tics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cologne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cologne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to evaluate the efficacy of a resources activation based&#xD;
      treatment programme in children and adolescents aged 8 to 18 years with tic disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main purpose of this study is to evaluate the efficacy of an intervention aimed at the&#xD;
      activation of resources for children and adolescents with tic disorders. The activation of&#xD;
      resources treatment programme was developed at Department of Child and Adolescent Psychiatry&#xD;
      and Psychotherapy at the University of Cologne and is currently evaluated in different&#xD;
      studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2013</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Symptom Checklist for Tic-Symptoms (FBB-TIC), parent rating</measure>
    <time_frame>Baseline (T0), after 8 weeks (T1), 16weeks (T2), 24weeks (T3)</time_frame>
    <description>The FBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-esteem (Harter-Scale-SBB)(self rating)</measure>
    <time_frame>T0, after 8 weeks (T1), 24weeks (T3)</time_frame>
    <description>The Harter-Scale is used to assess self-esteem</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Symptom Checklist for Tic-Symptoms (FBB-/SBB-TIC), Teacher-/self-rating</measure>
    <time_frame>Baseline (T0), after 8 weeks (T1), 16 weeks (T2), 24weeks (T3)</time_frame>
    <description>The SBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Symptom Checklist for Tic-Symptoms, clinical rating</measure>
    <time_frame>Baseline (T0), after 8 weeks (T1), 16weeks (T2), 24weeks (T3)</time_frame>
    <description>The Checklist is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by clinicians</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of comorbid ADHD Symptoms (FBB/SBB-ADHD), parent, teacher and self-rating</measure>
    <time_frame>T0, after 8 weeks (T1), 24 weeks (T3)</time_frame>
    <description>The Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-/SBB-ADHS) assess all symptom criteria according to DSM IV and ICD-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of comorbid OCD Symptoms (ZWIK-E), parent-rating</measure>
    <time_frame>T0, after 8 weeks (T1), 24weeks (T3)</time_frame>
    <description>The ZWIK assess OCD criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating</measure>
    <time_frame>T0, after 8 weeks (T1), 24weeks (T3)</time_frame>
    <description>The CBCL, TRF and YSR assess a variation of different criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tic-Symptoms (YGTSS-TIC), overall score</measure>
    <time_frame>Baseline (T0), after 8 weeks (T1),16weeks (T2), 24weeks (T3)</time_frame>
    <description>The YGTSS is used to assess Tic-Symptoms in a semi structured interview with parents and patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tic-Symptoms (observation)</measure>
    <time_frame>Between T1 and T3 up to 16 weeks, during each session/week</time_frame>
    <description>Tic symptoms are observed through video tapes and are rated through clinicians</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Tic-Disorder</condition>
  <arm_group>
    <arm_group_label>Resources activation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At first patients get informed about Tics in general. Through different exercises existing resources and skills are activated and strengthened. Feeling of self-esteem and self-respect are strengthened. Also the emotional awareness is strengthened. Relaxation methods are also introduced.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resources activation</intervention_name>
    <arm_group_label>Resources activation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  8-18 years&#xD;
&#xD;
          -  Diagnosis of chronic motor or vocal Tic (F95.1) or Tourette-Syndrome (F95.2)&#xD;
&#xD;
          -  YGTSS total score F95.2&gt;13, F95.1&gt;9&#xD;
&#xD;
          -  Tics are the main problems&#xD;
&#xD;
          -  IQ&gt;80&#xD;
&#xD;
          -  If medication, then has been stable for at least one months in medicated patients&#xD;
&#xD;
          -  No change in medication treatment is planned&#xD;
&#xD;
          -  Ability to participate in weekly outpatient treatment&#xD;
&#xD;
          -  Acceptance of randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Autism Spectrum Disorder or Psychosis&#xD;
&#xD;
          -  Parallel continuous psychotherapy of tics or comorbid&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manfred Döpfner, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Department of Childhood and Adolescent Psychiatry and Psychotherapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Cologne, Department of Childhood and Adolescent Psychiatry and Psychotherapy</name>
      <address>
        <city>Cologne</city>
        <zip>50931</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katrin Woitecki, Dr</last_name>
      <phone>(+49)221-478-97991</phone>
      <email>Tic-Ambulanz@uk-koeln.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Perri, D., Mandler, J. &amp; Döpfner, M. (2015). STARK - Supportive Therapie zur Aktivierung von Ressourcen. Göttingen: Hogrefe.</citation>
  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>April 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>March 14, 2017</last_update_submitted>
  <last_update_submitted_qc>March 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cologne</investigator_affiliation>
    <investigator_full_name>Manfred Doepfner</investigator_full_name>
    <investigator_title>Leading psychologist at the Department of Childhood and Adolescence Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Tic-Disorder, Tourette-Disorder, Resources activation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tics</mesh_term>
    <mesh_term>Tic 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/NCT02190370
org study id: THICS-Study 3
nct id: NCT02190370
lead sponsor: 
has dmc: No
The main purpose of this study is to evaluate the efficacy of a resources activation based
      treatment programme in children and adolescents aged 8 to 18 years with tic disorders.
The main purpose of this study is to evaluate the efficacy of an intervention aimed at the
      activation of resources for children and adolescents with tic disorders. The activation of
      resources treatment programme was developed at Department of Child and Adolescent Psychiatry
      and Psychotherapy at the University of Cologne and is currently evaluated in different
      studies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Symptom Checklist for Tic-Symptoms (FBB-TIC), parent rating
time frame: Baseline (T0), after 8 weeks (T1), 16weeks (T2), 24weeks (T3)
description: The FBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents
measure: Change in self-esteem (Harter-Scale-SBB)(self rating)
time frame: T0, after 8 weeks (T1), 24weeks (T3)
description: The Harter-Scale is used to assess self-esteem
measure: Change in Symptom Checklist for Tic-Symptoms (FBB-/SBB-TIC), Teacher-/self-rating
time frame: Baseline (T0), after 8 weeks (T1), 16 weeks (T2), 24weeks (T3)
description: The SBB-TIC is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by parents
measure: Change in Symptom Checklist for Tic-Symptoms, clinical rating
time frame: Baseline (T0), after 8 weeks (T1), 16weeks (T2), 24weeks (T3)
description: The Checklist is used to assess Tic-Symptoms according to DSM-IV and ICD-10 rated by clinicians
measure: Change of comorbid ADHD Symptoms (FBB/SBB-ADHD), parent, teacher and self-rating
time frame: T0, after 8 weeks (T1), 24 weeks (T3)
description: The Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-/SBB-ADHS) assess all symptom criteria according to DSM IV and ICD-10.
measure: Change of comorbid OCD Symptoms (ZWIK-E), parent-rating
time frame: T0, after 8 weeks (T1), 24weeks (T3)
description: The ZWIK assess OCD criteria.
measure: Change of comorbid Symptoms (CBCL/TRF/YSR), parent-/teacher-/self-rating
time frame: T0, after 8 weeks (T1), 24weeks (T3)
description: The CBCL, TRF and YSR assess a variation of different criteria.
measure: Change in Tic-Symptoms (YGTSS-TIC), overall score
time frame: Baseline (T0), after 8 weeks (T1),16weeks (T2), 24weeks (T3)
description: The YGTSS is used to assess Tic-Symptoms in a semi structured interview with parents and patients
measure: Change in Tic-Symptoms (observation)
time frame: Between T1 and T3 up to 16 weeks, during each session/week
description: Tic symptoms are observed through video tapes and are rated through clinicians
arm group label: Resources activation
arm group type: Experimental
description: At first patients get informed about Tics in general. Through different exercises existing resources and skills are activated and strengthened. Feeling of self-esteem and self-respect are strengthened. Also the emotional awareness is strengthened. Relaxation methods are also introduced.
intervention type: Behavioral
intervention name: Resources activation
arm group label: Resources activation
criteria: 
gender: All
minimum age: 8 Years
maximum age: 18 Years
healthy volunteers: No
last name: Manfred Döpfner, Prof. Dr.
role: Study Director
affiliation: Department of Childhood and Adolescent Psychiatry and Psychotherapy
facility: 
status: Recruiting
contact: 
country: Germany
citation: Perri, D., Mandler, J. & Döpfner, M. (2015). STARK - Supportive Therapie zur Aktivierung von Ressourcen. Göttingen: Hogrefe.
responsible party type: Principal Investigator
investigator affiliation: University of Cologne
investigator full name: Manfred Doepfner
investigator title: Leading psychologist at the Department of Childhood and Adolescence Psychiatry
mesh term: Tics
mesh term: Tic Disorders