<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT02257814</url>
  </required_header>
  <id_info>
    <org_study_id>HHSP23320072909YC</org_study_id>
    <nct_id>NCT02257814</nct_id>
  </id_info>
  <brief_title>Head Start Classroom-based Approaches and Resources for Emotion and Social Skill Promotion (Head Start CARES)</brief_title>
  <official_title>Head Start Classroom-based Approaches and Resources for Emotion and Social Skill Promotion (Head Start CARES)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MDRC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MDRC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to deepen the evidence base for interventions that support the&#xD;
      social-emotional skills that underlie children's engagement and attention to learning tasks&#xD;
      by schools (learning behaviors) and their social interactions with teachers and peers (social&#xD;
      behaviors). The study tested three theoretically-distinct approaches to enhancing children's&#xD;
      social-emotional development, along with a comprehensive coaching and training model, on a&#xD;
      large scale within the Head Start system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <primary_completion_date type="Actual">June 2012</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Classroom Climate: Classroom Assessment Scoring System (CLASS)</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>Class-level outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Teacher Practice: Adapted Teaching Style Rating Scale (TSRS)</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>Class-level outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Executive Function: Head-to-Toes</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>Child-level outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Executive Function: Pencil Tap</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>Child-level outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social Problem-Solving: Challenging Situations Task</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>Child-level outocme</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotion Knowledge: Emotion Situations and Identification Tasks</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>Child-level outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pre-Academic Skills: Academic Rating Scale</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>Child-level Outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pre-Academic Skills: Expressive One-Word Picture Vocabulary Test</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>Child-level outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pre-Academic Skills: Woodcock-Johnson III</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>Child-level outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Behavior Regulation: Behavior Problems Index</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>Child-level outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social Behaviors: Social Social Skills Rating Scale</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>Child-level outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social Behaviors: Cooper-Farran Behavioral Rating Scale- Interpersonal Skills</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>Child-level outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Learning Behaviors: Cooper-Farran Behavioral Rating Scale- Work-Related Skills</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>Child-level outcome</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">2670</enrollment>
  <condition>Teacher Practice</condition>
  <condition>Child Social-Emotional Development</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Incredible Years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>incredible years intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preschool PATHS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preschool PATHS (Promoting Alternative Thinking Strategies)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tools of the Mind</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tools of the Mind</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Incredible Years Teacher Training</intervention_name>
    <arm_group_label>Incredible Years</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Preschool PATHS</intervention_name>
    <arm_group_label>Preschool PATHS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tools of the Mind</intervention_name>
    <arm_group_label>Tools of the Mind</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Grantees had to have at least 4 centers with a similar racial/ethnic composition&#xD;
&#xD;
          -  An equal number of classrooms with full-day or part-day programs&#xD;
&#xD;
          -  And a similar mix of four-year-old-only and mixed-age (three-and four-year-old)&#xD;
             classrooms.&#xD;
&#xD;
          -  Children had to speak English and Spanish.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A grantee was excluded from the sample if it: only ran early Head Start programs&#xD;
&#xD;
          -  Only served migrant children&#xD;
&#xD;
          -  Was located in a U.S. territory&#xD;
&#xD;
          -  Only or mostly provided family child care or home services&#xD;
&#xD;
          -  Was more than 100 miles from a &quot;primary airport,&quot;&#xD;
&#xD;
          -  Operated fewer than 4 centers with two classrooms each&#xD;
&#xD;
          -  Had been in operation for less than 2 years&#xD;
&#xD;
          -  Was not in compliance with Head Start Standards&#xD;
&#xD;
          -  They were already systematically implementing a social-emotional curriculum or&#xD;
             participating in another evaluation study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>4 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pamela Morris, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>MDRC/New York University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MDRC</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Mattera, S, Lloyd, CM, Fishman, M, and Bangser, M. (2013). A First Look at the Head Start CARES Demonstration: Large-Scale Implementation of Programs to Improve Children's Social-Emotional Competence. OPRE Report 2013-47. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.</citation>
  </results_reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>March 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>October 3, 2014</last_update_submitted>
  <last_update_submitted_qc>October 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02257814
org study id: HHSP23320072909YC
nct id: NCT02257814
lead sponsor: 
has dmc: Yes
The purpose of this study was to deepen the evidence base for interventions that support the
      social-emotional skills that underlie children's engagement and attention to learning tasks
      by schools (learning behaviors) and their social interactions with teachers and peers (social
      behaviors). The study tested three theoretically-distinct approaches to enhancing children's
      social-emotional development, along with a comprehensive coaching and training model, on a
      large scale within the Head Start system.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Classroom Climate: Classroom Assessment Scoring System (CLASS)
time frame: 0 to 12 months
description: Class-level outcome
measure: Teacher Practice: Adapted Teaching Style Rating Scale (TSRS)
time frame: 0 to 12 months
description: Class-level outcome
measure: Executive Function: Head-to-Toes
time frame: 0 to 12 months
description: Child-level outcome
measure: Executive Function: Pencil Tap
time frame: 0 to 12 months
description: Child-level outcome
measure: Social Problem-Solving: Challenging Situations Task
time frame: 0 to 12 months
description: Child-level outocme
measure: Emotion Knowledge: Emotion Situations and Identification Tasks
time frame: 0 to 12 months
description: Child-level outcome
measure: Pre-Academic Skills: Academic Rating Scale
time frame: 0 to 12 months
description: Child-level Outcome
measure: Pre-Academic Skills: Expressive One-Word Picture Vocabulary Test
time frame: 0 to 12 months
description: Child-level outcome
measure: Pre-Academic Skills: Woodcock-Johnson III
time frame: 0 to 12 months
description: Child-level outcome
measure: Behavior Regulation: Behavior Problems Index
time frame: 0 to 12 months
description: Child-level outcome
measure: Social Behaviors: Social Social Skills Rating Scale
time frame: 0 to 12 months
description: Child-level outcome
measure: Social Behaviors: Cooper-Farran Behavioral Rating Scale- Interpersonal Skills
time frame: 0 to 12 months
description: Child-level outcome
measure: Learning Behaviors: Cooper-Farran Behavioral Rating Scale- Work-Related Skills
time frame: 0 to 12 months
description: Child-level outcome
arm group label: Control Group
arm group type: No Intervention
description: Control group
arm group label: Incredible Years
arm group type: Experimental
description: incredible years intervention
arm group label: Preschool PATHS
arm group type: Experimental
description: Preschool PATHS (Promoting Alternative Thinking Strategies)
arm group label: Tools of the Mind
arm group type: Experimental
description: Tools of the Mind
intervention type: Behavioral
intervention name: Incredible Years Teacher Training
arm group label: Incredible Years
intervention type: Behavioral
intervention name: Preschool PATHS
arm group label: Preschool PATHS
intervention type: Behavioral
intervention name: Tools of the Mind
arm group label: Tools of the Mind
criteria: 
gender: All
minimum age: 3 Years
maximum age: 4 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pamela Morris, Ph.D.
role: Principal Investigator
affiliation: MDRC/New York University
facility: 
country: United States
citation: Mattera, S, Lloyd, CM, Fishman, M, and Bangser, M. (2013). A First Look at the Head Start CARES Demonstration: Large-Scale Implementation of Programs to Improve Children's Social-Emotional Competence. OPRE Report 2013-47. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.
responsible party type: Sponsor