<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/NCT02225236</url>
  </required_header>
  <id_info>
    <org_study_id>FP00006613</org_study_id>
    <nct_id>NCT02225236</nct_id>
  </id_info>
  <brief_title>Improving Self-regulation &amp; School Readiness in Preschoolers</brief_title>
  <official_title>Improving Self-regulation &amp; School Readiness in Preschoolers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brady Education Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will develop and evaluate the initial effectiveness of an intervention training&#xD;
      executive functioning, metacognition, and self-regulation in preschoolers attending certain&#xD;
      high poverty Cincinnati preschools. Studies show that these skills are critical for school&#xD;
      performance, and that children with better executive functioning have better long term&#xD;
      outcomes. It is also important to intervene early when children are most likely to profit&#xD;
      because their brains are rapidly developing. There are some promising programs targeting&#xD;
      these skills in preschoolers, but few are available to teachers for implementation in the&#xD;
      classroom setting. The specific aims of this study are: 1) to adapt a promising clinic-based&#xD;
      program for the preschool classroom environment, and 2) to test the feasibility and initial&#xD;
      impact of the adapted program on executive functioning and school readiness in schools with a&#xD;
      high proportion of children from low income families.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We propose to translate a promising intervention, Executive-function Training for Attention&#xD;
      and Metacognition (ETAM), originally developed for use in a clinic setting, to be delivered&#xD;
      in the school setting, ultimately by teachers. Specifically, we propose to develop a&#xD;
      curriculum that can be added to the classroom curriculum which will target the development of&#xD;
      self-regulation and metacognition in preschoolers. Thus the purpose of the study is to 1)&#xD;
      develop a teacher training program based on the principles we have found to be effective in a&#xD;
      parent-based intervention and 2) test the feasibility and initial efficacy (i.e., reduced&#xD;
      disruptive behaviors and increased school readiness) of the program in children from low&#xD;
      income families. We will randomly assign 6 preschools to receive the teacher training&#xD;
      component and 6 schools to serve as a control group (i.e., will not receive the&#xD;
      intervention). We will conduct assessments on all preschoolers in the classroom prior to&#xD;
      delivering the teacher training (i.e., beginning of the school year), provide the training to&#xD;
      preschoolers in classrooms randomized to the active intervention group, and then conduct&#xD;
      assessments at the end of the school year. Our primary aims are to assess the feasibility of&#xD;
      a program designed to train teachers to incorporate the principles of the training program&#xD;
      into the daily classroom environment, and to assess whether the program improves executive&#xD;
      functioning and functional outcomes [i.e., Attention/Deficit-Hyperactivity Disorder (ADHD)&#xD;
      symptoms, academic readiness, social competence], as compared to outcomes of children in the&#xD;
      control schools. Although study personnel will be responsible for delivery of the&#xD;
      intervention, preschool teachers will be closely involved in the process to provide ongoing&#xD;
      feedback regarding the study intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Behavior Rating Inventory of Executive Function-Preschool Version</measure>
    <time_frame>Outcome assessment (~9 months after initial assessment)</time_frame>
    <description>Parents and teachers will complete this rating scale assessing executive function behaviors in the home and school environments, yielding T-scores on several subscales, including Inhibit, Shift, Emotional Control, Working Memory, Plan/Organize, Inhibitory Self-Control Index, Flexibility Index, Emergent Metacognition Index, and a Global Executive Composite. The scale has adequate reliability and validity as assessed in two- to five-year-olds</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Evaluation of Language Fundamentals - Preschool, Second Edition - Concepts and Following Directions</measure>
    <time_frame>Outcome evaluation (~9 months after baseline evaluation)</time_frame>
    <description>The Concepts and Following Directions subtest is a measure of auditory and visual attention. This subtest requires the child to interpret, recall, and execute oral commands of increasing length and complexity that contain concepts of functional language. A subscale score is computed for Concepts and Following Directions. Across ages (i.e., 3- to 7-year-olds), internal consistency ranged from .78 to .85 with an average of .82.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NEPSY- Attention/Executive Function subtests</measure>
    <time_frame>Outcome (~9 months after baseline evaluation)</time_frame>
    <description>The Visual Attention subtest is a measure of inhibition, scanning, vigilance, and impulsivity. This subtest is divided into two tasks (e.g., cats and faces, or bunnies and cats). The child is shown an exemplar at the top of the page (e.g., bunny) and is asked to circle all the bunnies amongst a number of other stimuli on the rest of the page as quickly as possible. The Statue subtest is a measure of motor persistence and inhibition. The child is asked to assume a pose and remain in it with their eyes closed for 75 seconds, ignoring distractors occurring at regular intervals. A subscale score is computed for each subtest. Reliabilities for the NEPSY at ages 3 through 7 are &gt; .70.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shape School</measure>
    <time_frame>Outcome (~9 months after baseline evaluation)</time_frame>
    <description>This assessment is a developmentally appropriate task developed for preschoolers assessing inhibition and switching. The child is presented with a colorful storybook of colorful circle and square figures and is administered 4 conditions (control, inhibit, switch, concurrent/both). In the control condition, the child names the colors of the figures as fast as possible. In the inhibit (response suppression) condition, the child only named the colors of the figures with happy faces and not frustrated faces. In the switch (attention control) condition, the child names the shapes of figures wearing hats. In the concurrent condition, the child is asked to name the figures (color or shape), who were both wearing hats and had happy faces. Cronbach's alpha coefficients for each condition exceeds 0.71.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swanson, Kotkin, Agler, M-Flynn, Pelham (SKAMP) Teacher Rating Scale</measure>
    <time_frame>Outcome (~9 months after baseline evaluation)</time_frame>
    <description>Teachers will be asked to complete the SKAMP to measure impairments in classroom functioning related to disruptive behaviors.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">237</enrollment>
  <condition>Executive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Classroom Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention focuses on training executive functioning (e.g., working memory and inhibition) and metacognition (i.e., the ability to predict, check, monitor, coordinate and control cognitive operations) using play activities and structured language and reinforcement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No treatment control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Classroom Intervention</intervention_name>
    <arm_group_label>Classroom Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All children in preschool classrooms in selected schools.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>Schools in the Archdiocese of Cincinnati to be determined</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>January 25, 2018</last_update_submitted>
  <last_update_submitted_qc>January 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>executive functioning</keyword>
  <keyword>metacognition</keyword>
  <keyword>self-regulation</keyword>
  <keyword>preschoolers</keyword>
  <!-- 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/NCT02225236
org study id: FP00006613
nct id: NCT02225236
lead sponsor: 
collaborator: 
has dmc: No
This project will develop and evaluate the initial effectiveness of an intervention training
      executive functioning, metacognition, and self-regulation in preschoolers attending certain
      high poverty Cincinnati preschools. Studies show that these skills are critical for school
      performance, and that children with better executive functioning have better long term
      outcomes. It is also important to intervene early when children are most likely to profit
      because their brains are rapidly developing. There are some promising programs targeting
      these skills in preschoolers, but few are available to teachers for implementation in the
      classroom setting. The specific aims of this study are: 1) to adapt a promising clinic-based
      program for the preschool classroom environment, and 2) to test the feasibility and initial
      impact of the adapted program on executive functioning and school readiness in schools with a
      high proportion of children from low income families.
We propose to translate a promising intervention, Executive-function Training for Attention
      and Metacognition (ETAM), originally developed for use in a clinic setting, to be delivered
      in the school setting, ultimately by teachers. Specifically, we propose to develop a
      curriculum that can be added to the classroom curriculum which will target the development of
      self-regulation and metacognition in preschoolers. Thus the purpose of the study is to 1)
      develop a teacher training program based on the principles we have found to be effective in a
      parent-based intervention and 2) test the feasibility and initial efficacy (i.e., reduced
      disruptive behaviors and increased school readiness) of the program in children from low
      income families. We will randomly assign 6 preschools to receive the teacher training
      component and 6 schools to serve as a control group (i.e., will not receive the
      intervention). We will conduct assessments on all preschoolers in the classroom prior to
      delivering the teacher training (i.e., beginning of the school year), provide the training to
      preschoolers in classrooms randomized to the active intervention group, and then conduct
      assessments at the end of the school year. Our primary aims are to assess the feasibility of
      a program designed to train teachers to incorporate the principles of the training program
      into the daily classroom environment, and to assess whether the program improves executive
      functioning and functional outcomes [i.e., Attention/Deficit-Hyperactivity Disorder (ADHD)
      symptoms, academic readiness, social competence], as compared to outcomes of children in the
      control schools. Although study personnel will be responsible for delivery of the
      intervention, preschool teachers will be closely involved in the process to provide ongoing
      feedback regarding the study intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Behavior Rating Inventory of Executive Function-Preschool Version
time frame: Outcome assessment (~9 months after initial assessment)
description: Parents and teachers will complete this rating scale assessing executive function behaviors in the home and school environments, yielding T-scores on several subscales, including Inhibit, Shift, Emotional Control, Working Memory, Plan/Organize, Inhibitory Self-Control Index, Flexibility Index, Emergent Metacognition Index, and a Global Executive Composite. The scale has adequate reliability and validity as assessed in two- to five-year-olds
measure: Clinical Evaluation of Language Fundamentals - Preschool, Second Edition - Concepts and Following Directions
time frame: Outcome evaluation (~9 months after baseline evaluation)
description: The Concepts and Following Directions subtest is a measure of auditory and visual attention. This subtest requires the child to interpret, recall, and execute oral commands of increasing length and complexity that contain concepts of functional language. A subscale score is computed for Concepts and Following Directions. Across ages (i.e., 3- to 7-year-olds), internal consistency ranged from .78 to .85 with an average of .82.
measure: NEPSY- Attention/Executive Function subtests
time frame: Outcome (~9 months after baseline evaluation)
description: The Visual Attention subtest is a measure of inhibition, scanning, vigilance, and impulsivity. This subtest is divided into two tasks (e.g., cats and faces, or bunnies and cats). The child is shown an exemplar at the top of the page (e.g., bunny) and is asked to circle all the bunnies amongst a number of other stimuli on the rest of the page as quickly as possible. The Statue subtest is a measure of motor persistence and inhibition. The child is asked to assume a pose and remain in it with their eyes closed for 75 seconds, ignoring distractors occurring at regular intervals. A subscale score is computed for each subtest. Reliabilities for the NEPSY at ages 3 through 7 are > .70.
measure: Shape School
time frame: Outcome (~9 months after baseline evaluation)
description: This assessment is a developmentally appropriate task developed for preschoolers assessing inhibition and switching. The child is presented with a colorful storybook of colorful circle and square figures and is administered 4 conditions (control, inhibit, switch, concurrent/both). In the control condition, the child names the colors of the figures as fast as possible. In the inhibit (response suppression) condition, the child only named the colors of the figures with happy faces and not frustrated faces. In the switch (attention control) condition, the child names the shapes of figures wearing hats. In the concurrent condition, the child is asked to name the figures (color or shape), who were both wearing hats and had happy faces. Cronbach's alpha coefficients for each condition exceeds 0.71.
measure: Swanson, Kotkin, Agler, M-Flynn, Pelham (SKAMP) Teacher Rating Scale
time frame: Outcome (~9 months after baseline evaluation)
description: Teachers will be asked to complete the SKAMP to measure impairments in classroom functioning related to disruptive behaviors.
arm group label: Classroom Intervention
arm group type: Experimental
description: The intervention focuses on training executive functioning (e.g., working memory and inhibition) and metacognition (i.e., the ability to predict, check, monitor, coordinate and control cognitive operations) using play activities and structured language and reinforcement.
arm group label: No treatment control
arm group type: No Intervention
description: No intervention
intervention type: Behavioral
intervention name: Classroom Intervention
arm group label: Classroom Intervention
criteria: 
gender: All
minimum age: 3 Years
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Leanne Tamm, Ph.D.
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
responsible party type: Sponsor