<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/NCT01660464</url>
  </required_header>
  <id_info>
    <org_study_id>ADHD-Team-03</org_study_id>
    <nct_id>NCT01660464</nct_id>
  </id_info>
  <brief_title>Guided Self-Help for Parents of Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)</brief_title>
  <official_title>Guided Self-Help for Parents of Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD): A Feasibility and Effectiveness Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cologne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cologne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cognitive-behavioral based guided self-help for parents of adolescents with&#xD;
      Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and&#xD;
      effectiveness study. The treatment is offered under routine-care conditions of the&#xD;
      health-care system in Germany. Practicability, treatment participation and effectiveness is&#xD;
      documented and tested in a one-group pre-test/post-test design.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Self-directed interventions may overcome many of the barriers associated with accessing&#xD;
      face-to-face services, as there is lowered stigma and significantly reduced or eliminated&#xD;
      cost, transport, and timing difficulties. Families can complete self-directed programs at&#xD;
      home, in their own time and at their own pace. Furthermore self-administered programs are&#xD;
      often very cost-effective and their use can ease the financial burden of mental health of the&#xD;
      community. These parenting programs can be particularly effective by reaching the populace.&#xD;
      Moreover in primary care settings where financial resources, time and expertise might be&#xD;
      lacking to provide behavioral interventions, self-directed programs might be a promising tool&#xD;
      for disseminating effective parenting interventions more widely.&#xD;
&#xD;
      Bibliotherapy is one form of self-directed therapy. In bibliotherapy a selected book is&#xD;
      thought to meet the specific need of the person to be treated and reading is used as the&#xD;
      therapeutic technique. In opposition to pure self-help programs, bibliotherapy in terms of&#xD;
      guided self-help provides patients (or parents) with written instructions as well as&#xD;
      therapeutic contacts at regular intervals. During these contacts, problems and questions can&#xD;
      be discussed to give further support. Self-help interventions have already proven to be&#xD;
      effective for adults with anxiety or affective disorders as well as for depressive&#xD;
      adolescents. However there has only been little research concerning the reduction of&#xD;
      children's and adolescent´s behaviour problems through parental self-help programs under&#xD;
      minimal contact conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>Total score of the Symptom Checklist Attention-Deficit/Hyperactivity Disorder (SCL-ADHD, Döpfner, Görtz-Dorten &amp; Lehmkuhl, 2008</measure>
    <time_frame>1 year</time_frame>
    <description>Questionnaire assesses the diagnostic criteria of DSM-IV and ICD-10 for ADHD. Informant is participating parent.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Strengths &amp; Difficulties Questionnaire (SDQ)</measure>
    <time_frame>1 year</time_frame>
    <description>Questionnaire assesses comorbid symptoms. Informant is the participating parent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Questionnaire KINDL (Ravens-Sieberer &amp; Bullinger, 2000)</measure>
    <time_frame>1 year</time_frame>
    <description>Questionnaire assesses child´s quality of life. Informant is participating parent.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Attention-Deficit/Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>ADHD-Team</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT Based Self-help Workbook + Counseling Telepho</intervention_name>
    <description>Over a period of 12 months parents work through 8 self-help booklets and additionally receive 14 counseling telephone calls. The intervention has a cognitive-behavioral foundation. Primary purpose of counseling telephone calls is to clarify contents of the booklets and support parents in managing their homework assignments accompanied with each booklet.</description>
    <arm_group_label>ADHD-Team</arm_group_label>
    <other_name>Guided self help</other_name>
    <other_name>behavioral treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescent with a diagnosis of ADHD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Language or reading difficulties of participating parent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne</name>
      <address>
        <city>Cologne</city>
        <state>NRW</state>
        <zip>D-50931</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <last_update_submitted>April 14, 2014</last_update_submitted>
  <last_update_submitted_qc>April 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 15, 2014</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 Child and Adolescent Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Program evaluation</keyword>
  <keyword>ADHD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</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/NCT01660464
org study id: ADHD-Team-03
nct id: NCT01660464
lead sponsor: 
collaborator: 
has dmc: No
Cognitive-behavioral based guided self-help for parents of adolescents with
      Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and
      effectiveness study. The treatment is offered under routine-care conditions of the
      health-care system in Germany. Practicability, treatment participation and effectiveness is
      documented and tested in a one-group pre-test/post-test design.
Self-directed interventions may overcome many of the barriers associated with accessing
      face-to-face services, as there is lowered stigma and significantly reduced or eliminated
      cost, transport, and timing difficulties. Families can complete self-directed programs at
      home, in their own time and at their own pace. Furthermore self-administered programs are
      often very cost-effective and their use can ease the financial burden of mental health of the
      community. These parenting programs can be particularly effective by reaching the populace.
      Moreover in primary care settings where financial resources, time and expertise might be
      lacking to provide behavioral interventions, self-directed programs might be a promising tool
      for disseminating effective parenting interventions more widely.

      Bibliotherapy is one form of self-directed therapy. In bibliotherapy a selected book is
      thought to meet the specific need of the person to be treated and reading is used as the
      therapeutic technique. In opposition to pure self-help programs, bibliotherapy in terms of
      guided self-help provides patients (or parents) with written instructions as well as
      therapeutic contacts at regular intervals. During these contacts, problems and questions can
      be discussed to give further support. Self-help interventions have already proven to be
      effective for adults with anxiety or affective disorders as well as for depressive
      adolescents. However there has only been little research concerning the reduction of
      children's and adolescent´s behaviour problems through parental self-help programs under
      minimal contact conditions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Total score of the Symptom Checklist Attention-Deficit/Hyperactivity Disorder (SCL-ADHD, Döpfner, Görtz-Dorten & Lehmkuhl, 2008
time frame: 1 year
description: Questionnaire assesses the diagnostic criteria of DSM-IV and ICD-10 for ADHD. Informant is participating parent.
measure: Strengths & Difficulties Questionnaire (SDQ)
time frame: 1 year
description: Questionnaire assesses comorbid symptoms. Informant is the participating parent.
measure: Quality of Life Questionnaire KINDL (Ravens-Sieberer & Bullinger, 2000)
time frame: 1 year
description: Questionnaire assesses child´s quality of life. Informant is participating parent.
arm group label: ADHD-Team
arm group type: Experimental
description: Intervention
intervention type: Behavioral
intervention name: CBT Based Self-help Workbook + Counseling Telepho
description: Over a period of 12 months parents work through 8 self-help booklets and additionally receive 14 counseling telephone calls. The intervention has a cognitive-behavioral foundation. Primary purpose of counseling telephone calls is to clarify contents of the booklets and support parents in managing their homework assignments accompanied with each booklet.
arm group label: ADHD-Team
other name: Guided self help
other name: behavioral treatment
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Cologne
investigator full name: Manfred Doepfner
investigator title: Leading psychologist at the Department of Child and Adolescent Psychiatry
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity