<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/NCT01660425</url>
  </required_header>
  <id_info>
    <org_study_id>ADHD-TEAM-02</org_study_id>
    <secondary_id>2486738</secondary_id>
    <nct_id>NCT01660425</nct_id>
  </id_info>
  <brief_title>Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support</brief_title>
  <official_title>Enhancement of Psychosocial Functioning, Quality of Life, Satisfaction With Medication and Medication Compliance of Methylphenidate Treatment by Psychosocial Intervention and Support</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cologne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shire</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>
      The main purpose of this study is to evaluate the effectiveness of a parenting enhancement&#xD;
      training (PET) for parents with children diagnosed with Attention Deficit-/Hyperactivity&#xD;
      Disorder (ADHD) who are already medicated with methylphenidate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main purpose of this study is to evaluate the effectiveness of a parenting enhancement&#xD;
      training (PET) for parents with children diagnosed with Attention Deficit-/Hyperactivity&#xD;
      Disorder (ADHD) already medicated with methylphenidate (MPH). This particular PET was&#xD;
      developed at the Department of Child and Adolescent Psychiatry and Psychotherapy at the&#xD;
      University of Cologne and has already been evaluated in several studies. MPH treatment has&#xD;
      been proven to be efficacious in the reduction of ADHD symptoms. However, despite optimal&#xD;
      titration a substantial percentage of children still suffer from residual symptoms and&#xD;
      impairment in psychosocial functioning. Therefore, there is still room for improvement in&#xD;
      satisfaction with medication. Moreover, a substantial rate of patients with good treatment&#xD;
      effects fails to comply with medication during the course of treatment. This parenting&#xD;
      enhancement training (PET) mainly conducted via written materials and telephone support will&#xD;
      be introduced in patients already treated with MPH. Effects are expected on symptoms of ADHD&#xD;
      as well as on comorbid oppositional symptoms. Further outcome parameters are satisfaction&#xD;
      with medication and medication compliance of MPH treatment, psychosocial functioning as well&#xD;
      as parenting skills. Parenting skills are a main focus of the PET and ADHD symptoms shall be&#xD;
      improved through improving parenting skills. Besides focusing on symptoms, recent research&#xD;
      often focuses on improvement of quality of life and impairment in psychosocial functioning&#xD;
      (e. g. family, school, leisure time) as well. Not only suffer patients from the main&#xD;
      symptoms. Many patients suffer as well from the symptoms' consequences, which is often an&#xD;
      overall impairment. Satisfaction with medication and medication compliance are fundamental&#xD;
      conditions for the success of a long term medical therapy. However, many studies show a lack&#xD;
      of compliance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">March 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating</measure>
    <time_frame>baseline, six months, 12 months; 16 months (control group)</time_frame>
    <description>The WFIRS-P is used for the assessment of psychosocial functioning of children diagnosed with ADHD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-ADHS), parent rating</measure>
    <time_frame>baseline, six months, 12 months; 16 months (control group)</time_frame>
    <description>The FBB-ADHS is used to assess symptoms of ADHD according to DSM-IV and ICD-10 rated by a parent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent rating</measure>
    <time_frame>baseline, six months, 12 months; 16 months (control group)</time_frame>
    <description>The Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV) is used to assess symptoms of ODD and some of the symptoms of Conduct Disorders according to ICD-10 and DSM-IV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Individual Problem Checklist (IPC), parent rating</measure>
    <time_frame>baseline, six months, 12 months; 16 months</time_frame>
    <description>The IPC assesses individual problems as defined together with the parents. It represents the individual problems which were aimed to reduce with the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Satisfaction with Medication Scale (SAMS), parent rating</measure>
    <time_frame>baseline, six months, 12 months; 16 months (control group)</time_frame>
    <description>The SAMS is used to assess parents' satisfaction with the medication of their child as well as with the effects of medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in &quot;Compliance Scale&quot;, parent rating</measure>
    <time_frame>baseline, six months, 12 months; 16 months (control group)</time_frame>
    <description>Newly developed parent questionnaire consisting of five items to assess the medication compliance of the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire to assess adverse effects of medication, taken from the Day Profile of ADHD Symptoms (DAYAS)</measure>
    <time_frame>baseline, six months, 12 months; 16 months (control group)</time_frame>
    <description>Subscale of the Day Profile of ADHD Symptoms (DAYAS) which assesses in 11 items the most frequent side effects of ADHD medication</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Attention Deficit-/Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>treatment as usual with MPH</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the first twelve months of intervention the children receive treatment as usual with MPH and do not get any further intervention. Afterwards, the families get the opportunity to take part in the program which is then conducted for a duration of four months. Measurements are performed at the beginning of the program, after six moths, after 12 months and additionally after 16 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychosocial intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Parenting Enhancement Training as a form of psychosocial intervention is a guided program. Parents get the opportunity to discuss written information with a therapist in 20 minutes telephone calls. 14 telephone calls are offered. The whole intervention lasts for a period of one year. Booklets are mailed via post within the first 4 months. First 9 telephone calls are also within the first 4 months, usually every two weeks. Telephone calls 10 and 11 are within 5th or 6th month, telephone calls 12 to 14 are within 7th to 12th month with a two monthly time period in between.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhancement with psychosocial intervention</intervention_name>
    <arm_group_label>Psychosocial intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The child attends school and is aged 6 to 12&#xD;
&#xD;
          -  Primary diagnosis of ADHD&#xD;
&#xD;
          -  Medication with methylphenidate in stable doses for at least two months&#xD;
&#xD;
          -  Currently, no change of medication is planned&#xD;
&#xD;
          -  The parents are motivated to participate in the parenting enhancement training&#xD;
&#xD;
          -  The parents have a command of written and spoken German&#xD;
&#xD;
          -  Psychosocial impairment measured with WFIRS-P&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - the family takes presumably part in psychotherapy with an intensive parenting training&#xD;
        component during the duration of the intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manfred Doepfner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cologne</affiliation>
  </overall_official>
  <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>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <last_update_submitted>March 12, 2014</last_update_submitted>
  <last_update_submitted_qc>March 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 13, 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 Childhood and Adolescence Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Attention deficit-/hyperactivity disorder</keyword>
  <keyword>parenting enhancement training</keyword>
  <keyword>guided self-help</keyword>
  <keyword>methylphenidate</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/NCT01660425
org study id: ADHD-TEAM-02
secondary id: 2486738
nct id: NCT01660425
lead sponsor: 
collaborator: 
has dmc: No
The main purpose of this study is to evaluate the effectiveness of a parenting enhancement
      training (PET) for parents with children diagnosed with Attention Deficit-/Hyperactivity
      Disorder (ADHD) who are already medicated with methylphenidate.
The main purpose of this study is to evaluate the effectiveness of a parenting enhancement
      training (PET) for parents with children diagnosed with Attention Deficit-/Hyperactivity
      Disorder (ADHD) already medicated with methylphenidate (MPH). This particular PET was
      developed at the Department of Child and Adolescent Psychiatry and Psychotherapy at the
      University of Cologne and has already been evaluated in several studies. MPH treatment has
      been proven to be efficacious in the reduction of ADHD symptoms. However, despite optimal
      titration a substantial percentage of children still suffer from residual symptoms and
      impairment in psychosocial functioning. Therefore, there is still room for improvement in
      satisfaction with medication. Moreover, a substantial rate of patients with good treatment
      effects fails to comply with medication during the course of treatment. This parenting
      enhancement training (PET) mainly conducted via written materials and telephone support will
      be introduced in patients already treated with MPH. Effects are expected on symptoms of ADHD
      as well as on comorbid oppositional symptoms. Further outcome parameters are satisfaction
      with medication and medication compliance of MPH treatment, psychosocial functioning as well
      as parenting skills. Parenting skills are a main focus of the PET and ADHD symptoms shall be
      improved through improving parenting skills. Besides focusing on symptoms, recent research
      often focuses on improvement of quality of life and impairment in psychosocial functioning
      (e. g. family, school, leisure time) as well. Not only suffer patients from the main
      symptoms. Many patients suffer as well from the symptoms' consequences, which is often an
      overall impairment. Satisfaction with medication and medication compliance are fundamental
      conditions for the success of a long term medical therapy. However, many studies show a lack
      of compliance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating
time frame: baseline, six months, 12 months; 16 months (control group)
description: The WFIRS-P is used for the assessment of psychosocial functioning of children diagnosed with ADHD.
measure: Change in Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-ADHS), parent rating
time frame: baseline, six months, 12 months; 16 months (control group)
description: The FBB-ADHS is used to assess symptoms of ADHD according to DSM-IV and ICD-10 rated by a parent.
measure: Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent rating
time frame: baseline, six months, 12 months; 16 months (control group)
description: The Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV) is used to assess symptoms of ODD and some of the symptoms of Conduct Disorders according to ICD-10 and DSM-IV.
measure: Change in Individual Problem Checklist (IPC), parent rating
time frame: baseline, six months, 12 months; 16 months
description: The IPC assesses individual problems as defined together with the parents. It represents the individual problems which were aimed to reduce with the treatment.
measure: Change in Satisfaction with Medication Scale (SAMS), parent rating
time frame: baseline, six months, 12 months; 16 months (control group)
description: The SAMS is used to assess parents' satisfaction with the medication of their child as well as with the effects of medication.
measure: Change in "Compliance Scale", parent rating
time frame: baseline, six months, 12 months; 16 months (control group)
description: Newly developed parent questionnaire consisting of five items to assess the medication compliance of the patient
measure: Questionnaire to assess adverse effects of medication, taken from the Day Profile of ADHD Symptoms (DAYAS)
time frame: baseline, six months, 12 months; 16 months (control group)
description: Subscale of the Day Profile of ADHD Symptoms (DAYAS) which assesses in 11 items the most frequent side effects of ADHD medication
arm group label: treatment as usual with MPH
arm group type: No Intervention
description: In the first twelve months of intervention the children receive treatment as usual with MPH and do not get any further intervention. Afterwards, the families get the opportunity to take part in the program which is then conducted for a duration of four months. Measurements are performed at the beginning of the program, after six moths, after 12 months and additionally after 16 months.
arm group label: Psychosocial intervention
arm group type: Active Comparator
description: Parenting Enhancement Training as a form of psychosocial intervention is a guided program. Parents get the opportunity to discuss written information with a therapist in 20 minutes telephone calls. 14 telephone calls are offered. The whole intervention lasts for a period of one year. Booklets are mailed via post within the first 4 months. First 9 telephone calls are also within the first 4 months, usually every two weeks. Telephone calls 10 and 11 are within 5th or 6th month, telephone calls 12 to 14 are within 7th to 12th month with a two monthly time period in between.
intervention type: Behavioral
intervention name: Enhancement with psychosocial intervention
arm group label: Psychosocial intervention
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Manfred Doepfner, PhD
role: Principal Investigator
affiliation: University of Cologne
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 Childhood and Adolescence Psychiatry
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity