<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/NCT03042338</url>
  </required_header>
  <id_info>
    <org_study_id>R34MH102499</org_study_id>
    <secondary_id>R34MH102499</secondary_id>
    <nct_id>NCT03042338</nct_id>
  </id_info>
  <brief_title>Central Executive Training for ADHD</brief_title>
  <acronym>CET</acronym>
  <official_title>Evaluating the Feasibility of Central Executive Training for Children With ADHD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Florida State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Feasibility study of Central Executive Training (CET) for ADHD. The goal of the current&#xD;
      project is to develop and assess the feasibility, acceptability, engagement, and usability of&#xD;
      a novel, central executive (CE) working memory training intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the core study is to develop a central executive training (CET) intervention for&#xD;
      children with attention-deficit/hyperactivity disorder (ADHD) and examine its feasibility,&#xD;
      acceptability, engagement, and usability. This will involve early developmental work on&#xD;
      software and treatment manuals followed by evaluation of the feasibility of enrolling,&#xD;
      retaining, and treating ADHD children with CET. An evidence-informed intervention targeting&#xD;
      central executive functioning in children with ADHD has the potential to result in clinically&#xD;
      significant improvements in ADHD symptoms relative to extant behavioral treatments and&#xD;
      capacity-based (short-term memory) training interventions. The long-term goal is to develop&#xD;
      an efficacious and acceptable CET intervention with the potential for generalized&#xD;
      improvements in, or normalization of, ADHD-related impairments in peer, family, and academic&#xD;
      functioning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 31, 2017</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rapport visuospatial/phonological working memory test</measure>
    <time_frame>Approximately 10 minute task administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session</time_frame>
    <description>Outcome: stimuli correct</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parent-reported ADHD symptoms (ADHD-5 rating scale)</measure>
    <time_frame>Parent questionnaire requiring approximately 15 minutes to complete, administered to parent while child is completing the 3 hour post-treatment testing session occurring within 2 weeks of last intervention session</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Kaufman Test of Educational Achievement-3 (KTEA3) Reading Comprehension</measure>
    <time_frame>Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)</time_frame>
    <description>Growth scale value (GSV)</description>
  </other_outcome>
  <other_outcome>
    <measure>NIH List Sorting</measure>
    <time_frame>Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)</time_frame>
    <description>Assessing feasibility of this test as possible primary outcomes for follow-up trial</description>
  </other_outcome>
  <other_outcome>
    <measure>Teacher ADHD symptom ratings (ADHD-5 rating scale)</measure>
    <time_frame>Teacher questionnaire requiring approximately 15 minutes to complete, mailed to teacher within 2 weeks of child's last intervention session</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Inhibition test</measure>
    <time_frame>Approximately 10 minute task administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session</time_frame>
    <description>Stop-signal and go/no-go scores will be combined via weighted average (factor score). Divergent validity (expected to improve more in comparison condition than experimental condition).</description>
  </other_outcome>
  <other_outcome>
    <measure>Kaufman Test of Educational Achievement-3 (KTEA3) Listening Comprehension</measure>
    <time_frame>Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)</time_frame>
    <description>Growth scale value (GSV)</description>
  </other_outcome>
  <other_outcome>
    <measure>Kaufman Test of Educational Achievement-3 (KTEA3) Math Concepts and Applications</measure>
    <time_frame>Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)</time_frame>
    <description>Growth scale value (GSV)</description>
  </other_outcome>
  <other_outcome>
    <measure>Kaufman Test of Educational Achievement-3 (KTEA3) Reading Fluency</measure>
    <time_frame>Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)</time_frame>
    <description>Growth scale value (GSV)</description>
  </other_outcome>
  <other_outcome>
    <measure>Kaufman Test of Educational Achievement-3 (KTEA3) Math Fluency</measure>
    <time_frame>Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)</time_frame>
    <description>Growth scale value (GSV)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>Central Executive Training1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Training tasks targeting working memory</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Central Executive Training2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Training tasks targeting inhibitory control and response speed</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CET: Central Executive Training</intervention_name>
    <description>CET: Central Executive Training</description>
    <arm_group_label>Central Executive Training1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CET: Comparison Executive Training</intervention_name>
    <description>CET: Comparison Executive Training</description>
    <arm_group_label>Central Executive Training2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children ages 8-12 with principal ADHD diagnoses (via K-SADS)&#xD;
&#xD;
          -  parent Behavior Assessment System for Children (BASC) Attention Problems or&#xD;
             Hyperactivity subscale or ADHD-5 in clinical/borderline range based on age and gender&#xD;
&#xD;
          -  teacher BASC Attention Problems or Hyperactivity subscale or ADHD-5 scale in&#xD;
             clinical/borderline range based on age and gender.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  gross neurological, sensory, or motor impairment, history of a seizure disorder, or&#xD;
             psychosis, bipolar disorders, substance use, or intellectual disability disorders&#xD;
&#xD;
          -  non-English speaking child or parent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Florida State University</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Florida State University</investigator_affiliation>
    <investigator_full_name>Michael J. Kofler</investigator_full_name>
    <investigator_title>Associate Professor</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03042338/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03042338
org study id: R34MH102499
secondary id: R34MH102499
nct id: NCT03042338
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Feasibility study of Central Executive Training (CET) for ADHD. The goal of the current
      project is to develop and assess the feasibility, acceptability, engagement, and usability of
      a novel, central executive (CE) working memory training intervention.
The goal of the core study is to develop a central executive training (CET) intervention for
      children with attention-deficit/hyperactivity disorder (ADHD) and examine its feasibility,
      acceptability, engagement, and usability. This will involve early developmental work on
      software and treatment manuals followed by evaluation of the feasibility of enrolling,
      retaining, and treating ADHD children with CET. An evidence-informed intervention targeting
      central executive functioning in children with ADHD has the potential to result in clinically
      significant improvements in ADHD symptoms relative to extant behavioral treatments and
      capacity-based (short-term memory) training interventions. The long-term goal is to develop
      an efficacious and acceptable CET intervention with the potential for generalized
      improvements in, or normalization of, ADHD-related impairments in peer, family, and academic
      functioning.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Rapport visuospatial/phonological working memory test
time frame: Approximately 10 minute task administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session
description: Outcome: stimuli correct
measure: Parent-reported ADHD symptoms (ADHD-5 rating scale)
time frame: Parent questionnaire requiring approximately 15 minutes to complete, administered to parent while child is completing the 3 hour post-treatment testing session occurring within 2 weeks of last intervention session
measure: Kaufman Test of Educational Achievement-3 (KTEA3) Reading Comprehension
time frame: Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)
description: Growth scale value (GSV)
measure: NIH List Sorting
time frame: Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)
description: Assessing feasibility of this test as possible primary outcomes for follow-up trial
measure: Teacher ADHD symptom ratings (ADHD-5 rating scale)
time frame: Teacher questionnaire requiring approximately 15 minutes to complete, mailed to teacher within 2 weeks of child's last intervention session
measure: Inhibition test
time frame: Approximately 10 minute task administered during a 3 hour post-treatment testing session occurring within 2 weeks of last intervention session
description: Stop-signal and go/no-go scores will be combined via weighted average (factor score). Divergent validity (expected to improve more in comparison condition than experimental condition).
measure: Kaufman Test of Educational Achievement-3 (KTEA3) Listening Comprehension
time frame: Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)
description: Growth scale value (GSV)
measure: Kaufman Test of Educational Achievement-3 (KTEA3) Math Concepts and Applications
time frame: Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)
description: Growth scale value (GSV)
measure: Kaufman Test of Educational Achievement-3 (KTEA3) Reading Fluency
time frame: Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)
description: Growth scale value (GSV)
measure: Kaufman Test of Educational Achievement-3 (KTEA3) Math Fluency
time frame: Approximately 15 minute task administered during a 3 hour follow-up testing session occurring 2-4 months after last intervention session (variable time frame to account for school breaks)
description: Growth scale value (GSV)
arm group label: Central Executive Training1
arm group type: Experimental
description: Training tasks targeting working memory
arm group label: Central Executive Training2
arm group type: Active Comparator
description: Training tasks targeting inhibitory control and response speed
intervention type: Behavioral
intervention name: CET: Central Executive Training
description: CET: Central Executive Training
arm group label: Central Executive Training1
intervention type: Behavioral
intervention name: CET: Comparison Executive Training
description: CET: Comparison Executive Training
arm group label: Central Executive Training2
criteria: 
gender: All
minimum age: 8 Years
maximum age: 13 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Florida State University
investigator full name: Michael J. Kofler
investigator title: Associate Professor
mesh term: Attention Deficit Disorder with Hyperactivity
sharing ipd: No
provided document: 