<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/NCT01677832</url>
  </required_header>
  <id_info>
    <org_study_id>201201062RIB</org_study_id>
    <nct_id>NCT01677832</nct_id>
  </id_info>
  <brief_title>Executive Functions and Self-Regulation Among Children With and Without ADHD in Germany and Taiwan</brief_title>
  <official_title>Neuronal Correlates of Executive Functions and Self-Regulation Among Children and Adolescents With and Without ADHD in Germany and Taiwan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Health Research Institutes, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children and adolescents with ADHD are impulsive and have difficulties in regulating their&#xD;
      behaviors. It has been suggested that a core deficit in inhibitory control may account for&#xD;
      dysfunctional behaviors associated with this disorder. Previous research has shown that&#xD;
      medication and the self-regulation strategy of making implementation intentions (i.e.,&#xD;
      if-then plans) are effective in enhancing children's inhibitory control, which is reflected&#xD;
      in the behavioral as well as electrophysiological (e.g., Electroencephalogram; EEG) data on a&#xD;
      Go/NoGo task in children with ADHD. As suggested by earlier research, however, forming&#xD;
      implementation intentions may have different effects on people who are embedded in different&#xD;
      cultures.&#xD;
&#xD;
      The aim of the present study is to compare the effects of medication and the self-regulation&#xD;
      of forming implementation intentions by assessing the behavioral performance and&#xD;
      corresponding brain activity during a Go/NoGo task in children and adolescents with and&#xD;
      without ADHD under two different cultural contexts. Further, this study also aims at&#xD;
      investigating the potential moderating effects of culture on making if-then plans. More&#xD;
      important, as we know, this will be the first study to compare the effectiveness of forming&#xD;
      implementation intentions on children and adolescents with ADHD in a cross-cultural way,&#xD;
      which is meaningful for researchers to explore the degree of its application and expected to&#xD;
      provide clinical psychologists an alternative perspective for ADHD treatment in the near&#xD;
      future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For a deeper understanding of the mechanism underlying the effects of MPH and implementation&#xD;
      intentions, neurophysiological data (with a special interest on the P300 component) during a&#xD;
      Go/NoGo task will be assessed additionally to the behavioral performance (i.e., response&#xD;
      times and error rates). Meanwhile, the information may contribute to a better understanding&#xD;
      of a potential influence of culture on the effect of implementation intentions. The effect&#xD;
      may be equally effective in the cultures, but the underlying processes might still differ. On&#xD;
      the other hand, differences between the two cultural groups might be explained by different&#xD;
      neurophysiological activity during the tasks.&#xD;
&#xD;
      Two primary research questions arise: (1) Are MPH and implementation intentions (i.e.,&#xD;
      if-then plans) effective in enhancing the performance of executive function tasks measured by&#xD;
      the Go/NoGo task in children and adolescents with ADHD compared with those without ADHD&#xD;
      within each culture? (2) Does culture play a role in moderating the effect of implementation&#xD;
      intentions on executive function tasks in children and adolescents with ADHD, respectively?&#xD;
      Based on the research questions, two hypotheses are formulated. First, after the treatment of&#xD;
      MPH and the self-regulation strategy of forming implementation intentions, it would result in&#xD;
      less inhibition errors and more increased amplitudes of NoGo P300 and NoGominusGo P300 in&#xD;
      children and adolescents with ADHD. Second, participants with ADHD in Taiwan may benefit more&#xD;
      from the self-regulation strategy, which is reflected in more increased amplitudes of NoGo&#xD;
      P300 and NoGominusGo P300 than found in their counterparts in Germany. However, since this is&#xD;
      the first study to compare the effects of forming implementation intentions in a&#xD;
      cross-cultural way, this latter analysis is more exploratory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Actual">December 31, 2014</completion_date>
  <primary_completion_date type="Actual">December 31, 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">180</enrollment>
  <condition>Attention-Deficit/Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>ADHD/Taiwan</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Control/Taiwan</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>ADHD/Germany</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Control/Germany</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited respectively in Germany and Taiwan using the same&#xD;
        standardized procedures according to the protocol. Children and adolescents with and&#xD;
        without ADHD between the ages 10 to 14, with an IQ full score ≥ 80, will participate in&#xD;
        this study. Participants with ADHD have to meet the criteria of ICD-10 (WHO, 1991) before&#xD;
        enrolment. They are diagnosed with ADHD combined subtype and have no comorbid disorders.&#xD;
        None of the controls are clinically diagnosed with any disorders and take any medication.&#xD;
        Both samples should be matched according to the variables: gender, IQ, and socio-economic&#xD;
        status (SES).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with ADHD have to meet the criteria of ICD-10 (WHO, 1991) before&#xD;
             enrolment.&#xD;
&#xD;
          -  Participants with ADHD are diagnosed with ADHD combined subtype.&#xD;
&#xD;
          -  Ages range from 10 to 14 when we conduct the study.&#xD;
&#xD;
          -  IQ full score ≥ 80.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subjects will be excluded from the study if they currently meet criteria or have a&#xD;
             history of the following condition as defined by DSM-IV: Schizophrenia,&#xD;
             Schizoaffective Disorder, Organic Psychosis, Mental Retardation, or Pervasive&#xD;
             Developmental Disorder. Moreover, the subjects will be excluded from the control group&#xD;
             if have a history of the following condition as defined by DSM-IV: ADHD or ASD in&#xD;
             addition to the above exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Shur-Fen Gau, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital &amp; College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan Univeristy Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>September 1, 2021</last_update_submitted>
  <last_update_submitted_qc>September 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Taiwan University Hospital</investigator_affiliation>
    <investigator_full_name>Statistical Center, NTUHCTC</investigator_full_name>
    <investigator_title>Susan Shur-Fen Gau</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT01677832
org study id: 201201062RIB
nct id: NCT01677832
lead sponsor: 
collaborator: 
has dmc: Yes
Children and adolescents with ADHD are impulsive and have difficulties in regulating their
      behaviors. It has been suggested that a core deficit in inhibitory control may account for
      dysfunctional behaviors associated with this disorder. Previous research has shown that
      medication and the self-regulation strategy of making implementation intentions (i.e.,
      if-then plans) are effective in enhancing children's inhibitory control, which is reflected
      in the behavioral as well as electrophysiological (e.g., Electroencephalogram; EEG) data on a
      Go/NoGo task in children with ADHD. As suggested by earlier research, however, forming
      implementation intentions may have different effects on people who are embedded in different
      cultures.

      The aim of the present study is to compare the effects of medication and the self-regulation
      of forming implementation intentions by assessing the behavioral performance and
      corresponding brain activity during a Go/NoGo task in children and adolescents with and
      without ADHD under two different cultural contexts. Further, this study also aims at
      investigating the potential moderating effects of culture on making if-then plans. More
      important, as we know, this will be the first study to compare the effectiveness of forming
      implementation intentions on children and adolescents with ADHD in a cross-cultural way,
      which is meaningful for researchers to explore the degree of its application and expected to
      provide clinical psychologists an alternative perspective for ADHD treatment in the near
      future.
For a deeper understanding of the mechanism underlying the effects of MPH and implementation
      intentions, neurophysiological data (with a special interest on the P300 component) during a
      Go/NoGo task will be assessed additionally to the behavioral performance (i.e., response
      times and error rates). Meanwhile, the information may contribute to a better understanding
      of a potential influence of culture on the effect of implementation intentions. The effect
      may be equally effective in the cultures, but the underlying processes might still differ. On
      the other hand, differences between the two cultural groups might be explained by different
      neurophysiological activity during the tasks.

      Two primary research questions arise: (1) Are MPH and implementation intentions (i.e.,
      if-then plans) effective in enhancing the performance of executive function tasks measured by
      the Go/NoGo task in children and adolescents with ADHD compared with those without ADHD
      within each culture? (2) Does culture play a role in moderating the effect of implementation
      intentions on executive function tasks in children and adolescents with ADHD, respectively?
      Based on the research questions, two hypotheses are formulated. First, after the treatment of
      MPH and the self-regulation strategy of forming implementation intentions, it would result in
      less inhibition errors and more increased amplitudes of NoGo P300 and NoGominusGo P300 in
      children and adolescents with ADHD. Second, participants with ADHD in Taiwan may benefit more
      from the self-regulation strategy, which is reflected in more increased amplitudes of NoGo
      P300 and NoGominusGo P300 than found in their counterparts in Germany. However, since this is
      the first study to compare the effects of forming implementation intentions in a
      cross-cultural way, this latter analysis is more exploratory.
observational model: Other
time perspective: Other
arm group label: ADHD/Taiwan
arm group label: Control/Taiwan
arm group label: ADHD/Germany
arm group label: Control/Germany
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 14 Years
healthy volunteers: No
last name: Susan Shur-Fen Gau, MD, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital & College of Medicine
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Taiwan University Hospital
investigator full name: Statistical Center, NTUHCTC
investigator title: Susan Shur-Fen Gau
mesh term: Attention Deficit Disorder with Hyperactivity