<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/NCT01675869</url>
  </required_header>
  <id_info>
    <org_study_id>R34MH095911</org_study_id>
    <nct_id>NCT01675869</nct_id>
  </id_info>
  <brief_title>Executive Function/Metacognitive Training for At-Risk Preschoolers</brief_title>
  <acronym>ETAM</acronym>
  <official_title>Executive Function/Metacognitive Training for At-Risk Preschoolers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see if an intervention training executive functions like&#xD;
      attention, working memory, and self-regulation for preschoolers at risk for&#xD;
      Attention-Deficit/Hyperactivity Disorder is feasible, acceptable to families, and improves&#xD;
      attention, behavior, and functioning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Disruptive behavior disorders, particularly Attention-Deficit/Hyperactivity Disorder (ADHD),&#xD;
      constitute one of the most common diagnoses in preschool children. Disruptive behaviors are a&#xD;
      major public health problem including causing significant emotional distress for caregivers&#xD;
      and children, expulsion from daycare or early education settings, demands on caregiver's&#xD;
      time, accident proneness and other safety concerns. However, few evidence-based early&#xD;
      interventions exist for preschoolers with attention and behavior problems, which is critical&#xD;
      because they are strongly suggested as the first line of treatment for preschoolers with&#xD;
      ADHD. Because executive functioning (EF) has been consistently been proposed as a putative&#xD;
      factor in the development of disruptive behavior disorders an intervention targeting EF&#xD;
      (e.g., inhibition, working memory), attention, and metacognition during early childhood could&#xD;
      likely affect the development of disruptive behavior disorders in preschoolers. Indeed, EF&#xD;
      skills are identified by kindergarten teachers as primary prerequisites for school success.&#xD;
      EF deficits independently contribute to poorer outcomes in ADHD, and have been linked&#xD;
      directly to academic and social functioning deficits. Given that EF and brain development are&#xD;
      rapidly developing during the preschool years, preschoolers may benefit most from an early&#xD;
      intervention targeting EF skills. Investigators have developed a promising intervention,&#xD;
      Executive Training of Attention and Metacognition (ETAM), for preschoolers, and have&#xD;
      conducted a small preliminary open trial demonstrating the initial acceptability of the&#xD;
      intervention. Investigators also found significant moderate effect sizes on objective&#xD;
      measures of EF and moderate to large effect size reductions in ratings of inattention and&#xD;
      behavioral symptoms by parents, clinicians, and teachers. A randomized clinical trial (RCT)&#xD;
      is needed to investigate if these positive effects on executive functioning, attention, and&#xD;
      behavior are due to ETAM or to the effect of parental attention and/or a placebo effect.&#xD;
      Investigators propose to assess the feasibility of a design for a future RCT. Investigators&#xD;
      will develop an attention control (AC) comparison group and assess the feasibility of:&#xD;
      identifying, enrolling and retaining preschoolers at-risk for ADHD, randomization choices,&#xD;
      the measurement of EF and functional outcomes, and delivery protocol for both AC and ETAM by&#xD;
      conducting a pilot RCT with 60 children at-risk for ADHD. Exploratory aims include assessing&#xD;
      whether children in the ETAM group show gains compared to those in AC on targeted (trained)&#xD;
      outcomes (i.e., measures of EF) and untrained outcomes (i.e., ADHD symptoms, academic&#xD;
      readiness, social competence). Investigators will also assess whether gains are maintained as&#xD;
      well as investigate potential moderators/mediators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Prevention</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Executive Functioning</measure>
    <time_frame>2 month follow-up</time_frame>
    <description>Investigators will compute an aggregated measure of EF deficits. For each EF measure investigators will define a threshold for adequate performance as a score obtained by 75% of the children. Performance will be dummy-coded according to this threshold as &quot;0&quot; for adequate performance and &quot;1&quot; for poor performance. We will then calculate a continuous measure of EF ranging from 0 (adequate performance on all) to 9 (poor performance on all), by summing the dummy coded scores of all EF measures.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>ETAM group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Executive Function/Metacognitive Training Program: An 8-week program, which addresses major areas of deficit in ADHD; namely, attention (the ability to concentrate and focus), inhibition (the ability to control ones behaviors), and memory (the ability to remember information).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Attention control group: An 8-week program which provides education regarding several topics relevant for preschool children including nutrition, sleep, temperament, etc.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Executive Training of Attention and Metacognition (ETAM)</intervention_name>
    <description>ETAM is an 8-week intervention involving weekly concurrent child (n=~6 per group) and parent intervention groups. The ETAM groups will be 1 hour in length (except for the first session which will be 2 hours).</description>
    <arm_group_label>ETAM group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Control</intervention_name>
    <description>Attention Control is an 8-week intervention involving weekly concurrent child (n=~6 per group) and parent groups that control for the effects of attention. The groups will be 1 hour in length (except for the first session which will be 2 hours).</description>
    <arm_group_label>Attention Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, ages 3.0-4.11 years&#xD;
&#xD;
          -  Outpatients, enrolled in a structured educational setting&#xD;
&#xD;
          -  At risk for ADHD&#xD;
&#xD;
          -  Parent or teacher rated BRIEF T-score &gt; 60 on at least 1 subscale&#xD;
&#xD;
          -  Not in other psychosocial interventions&#xD;
&#xD;
          -  Medication free at time of the intervention&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with significant impairment will be referred for more intensive treatment.&#xD;
&#xD;
          -  Pervasive developmental disorders&#xD;
&#xD;
          -  Serious head injury or unstable medical or neurological conditions&#xD;
&#xD;
          -  Judged by one of the investigators to be acutely suicidal or homicidal, or at imminent&#xD;
             risk of injuring self or others or causing significant damage to property&#xD;
&#xD;
          -  Children with an Intelligence Quotient (IQ) &lt;85 will be excluded to avoid confounds&#xD;
             related to intellectual functioning&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leanne Tamm, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Tamm L, Epstein JN, Loren REA, Becker SP, Brenner SB, Bamberger ME, Peugh J, Halperin JM. Generating Attention, Inhibition, and Memory: A Pilot Randomized Trial for Preschoolers With Executive Functioning Deficits. J Clin Child Adolesc Psychol. 2019;48(sup1):S131-S145. doi: 10.1080/15374416.2016.1266645. Epub 2017 Jan 20.</citation>
    <PMID>28107027</PMID>
  </results_reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>February 2, 2017</last_update_submitted>
  <last_update_submitted_qc>February 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Attention-Deficit/Hyperactivity Disorder</keyword>
  <keyword>Executive function</keyword>
  <keyword>Preschooler</keyword>
  <keyword>Metacognition</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/NCT01675869
org study id: R34MH095911
nct id: NCT01675869
lead sponsor: 
has dmc: No
The purpose of this study is to see if an intervention training executive functions like
      attention, working memory, and self-regulation for preschoolers at risk for
      Attention-Deficit/Hyperactivity Disorder is feasible, acceptable to families, and improves
      attention, behavior, and functioning.
Disruptive behavior disorders, particularly Attention-Deficit/Hyperactivity Disorder (ADHD),
      constitute one of the most common diagnoses in preschool children. Disruptive behaviors are a
      major public health problem including causing significant emotional distress for caregivers
      and children, expulsion from daycare or early education settings, demands on caregiver's
      time, accident proneness and other safety concerns. However, few evidence-based early
      interventions exist for preschoolers with attention and behavior problems, which is critical
      because they are strongly suggested as the first line of treatment for preschoolers with
      ADHD. Because executive functioning (EF) has been consistently been proposed as a putative
      factor in the development of disruptive behavior disorders an intervention targeting EF
      (e.g., inhibition, working memory), attention, and metacognition during early childhood could
      likely affect the development of disruptive behavior disorders in preschoolers. Indeed, EF
      skills are identified by kindergarten teachers as primary prerequisites for school success.
      EF deficits independently contribute to poorer outcomes in ADHD, and have been linked
      directly to academic and social functioning deficits. Given that EF and brain development are
      rapidly developing during the preschool years, preschoolers may benefit most from an early
      intervention targeting EF skills. Investigators have developed a promising intervention,
      Executive Training of Attention and Metacognition (ETAM), for preschoolers, and have
      conducted a small preliminary open trial demonstrating the initial acceptability of the
      intervention. Investigators also found significant moderate effect sizes on objective
      measures of EF and moderate to large effect size reductions in ratings of inattention and
      behavioral symptoms by parents, clinicians, and teachers. A randomized clinical trial (RCT)
      is needed to investigate if these positive effects on executive functioning, attention, and
      behavior are due to ETAM or to the effect of parental attention and/or a placebo effect.
      Investigators propose to assess the feasibility of a design for a future RCT. Investigators
      will develop an attention control (AC) comparison group and assess the feasibility of:
      identifying, enrolling and retaining preschoolers at-risk for ADHD, randomization choices,
      the measurement of EF and functional outcomes, and delivery protocol for both AC and ETAM by
      conducting a pilot RCT with 60 children at-risk for ADHD. Exploratory aims include assessing
      whether children in the ETAM group show gains compared to those in AC on targeted (trained)
      outcomes (i.e., measures of EF) and untrained outcomes (i.e., ADHD symptoms, academic
      readiness, social competence). Investigators will also assess whether gains are maintained as
      well as investigate potential moderators/mediators.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Care Provider, Outcomes Assessor)
measure: Executive Functioning
time frame: 2 month follow-up
description: Investigators will compute an aggregated measure of EF deficits. For each EF measure investigators will define a threshold for adequate performance as a score obtained by 75% of the children. Performance will be dummy-coded according to this threshold as "0" for adequate performance and "1" for poor performance. We will then calculate a continuous measure of EF ranging from 0 (adequate performance on all) to 9 (poor performance on all), by summing the dummy coded scores of all EF measures.
arm group label: ETAM group
arm group type: Experimental
description: Executive Function/Metacognitive Training Program: An 8-week program, which addresses major areas of deficit in ADHD; namely, attention (the ability to concentrate and focus), inhibition (the ability to control ones behaviors), and memory (the ability to remember information).
arm group label: Attention Control
arm group type: Active Comparator
description: Attention control group: An 8-week program which provides education regarding several topics relevant for preschool children including nutrition, sleep, temperament, etc.
intervention type: Behavioral
intervention name: Executive Training of Attention and Metacognition (ETAM)
description: ETAM is an 8-week intervention involving weekly concurrent child (n=~6 per group) and parent intervention groups. The ETAM groups will be 1 hour in length (except for the first session which will be 2 hours).
arm group label: ETAM group
intervention type: Behavioral
intervention name: Attention Control
description: Attention Control is an 8-week intervention involving weekly concurrent child (n=~6 per group) and parent groups that control for the effects of attention. The groups will be 1 hour in length (except for the first session which will be 2 hours).
arm group label: Attention Control
criteria: 
gender: All
minimum age: 3 Years
maximum age: 5 Years
healthy volunteers: No
last name: Leanne Tamm, Ph.D.
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
citation: Tamm L, Epstein JN, Loren REA, Becker SP, Brenner SB, Bamberger ME, Peugh J, Halperin JM. Generating Attention, Inhibition, and Memory: A Pilot Randomized Trial for Preschoolers With Executive Functioning Deficits. J Clin Child Adolesc Psychol. 2019;48(sup1):S131-S145. doi: 10.1080/15374416.2016.1266645. Epub 2017 Jan 20.
PMID: 28107027
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity