<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/NCT01670227</url>
  </required_header>
  <id_info>
    <org_study_id>5R01MH77331-2</org_study_id>
    <secondary_id>R01MH077331</secondary_id>
    <secondary_id>R305F050245</secondary_id>
    <nct_id>NCT01670227</nct_id>
  </id_info>
  <brief_title>ParentCorps: Promoting Healthy Development in Children From Low Income Communities</brief_title>
  <acronym>ParentCorps</acronym>
  <official_title>Preventing Conduct Problems in Poor Urban Preschoolers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>U.S. Department of Education</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to determine whether ParentCorps promotes academic achievement&#xD;
      and prevents mental health problems in children living in disadvantaged urban communities&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2005</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Academic achievement through Year 4</measure>
    <time_frame>Assessed twice per year in Years 1 and 2, and then annually through Year 4</time_frame>
    <description>Academic achievement test scores assessed via the Kaufman Test of Educational Achievement (KTEA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Child behavior at school through Year 4</measure>
    <time_frame>Assessed twice per year in Years 1 and 2, and then annually through Year 6</time_frame>
    <description>Masked observations of child behavior at school</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Academic performance through Year 4</measure>
    <time_frame>Assessed twice per year in Years 1 and 2, and then annually through Year 6</time_frame>
    <description>Teacher and parent ratings of academic performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Behavior through Year 4</measure>
    <time_frame>Assessed twice per year in Years 1 and 2, and then annually through Year 6</time_frame>
    <description>Teacher and parent ratings of behavior</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Parent engagement in school through Year 4</measure>
    <time_frame>Assessed twice per year in Years 1 and 2, and then annually through Year 6</time_frame>
    <description>Teacher rating of parent engagement in school</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Positive behavior support through Year 4</measure>
    <time_frame>Assessed twice per year in Years 1 and 2</time_frame>
    <description>Parent report of positive behavior support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Classroom climate and positive behavior support through Year 4</measure>
    <time_frame>Assessed twice per year in Years 1 and 2, and then annually through Year 4</time_frame>
    <description>Masked observations of classroom climate and positive behavior support</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1050</enrollment>
  <condition>Behavior Problems of Childhood and Adolescence</condition>
  <arm_group>
    <arm_group_label>PARENTCORPS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ParentCorps is a school-based, family-focused universal intervention designed to attenuate the multiple risks associated with urban poverty, on children's health and development</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Condition</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PARENTCORPS</intervention_name>
    <description>ParentCorps is a culturally-informed, universal intervention (for all children enrolled in Pre-K within an elementary school) designed to promote positive behavioral supports for children at home and in the classroom. ParentCorps includes two complementary components: 1) parent and child group intervention (13 2-hour sessions after school) for Pre-K students and their families; 2) professional development and individual consultation for early childhood teachers.</description>
    <arm_group_label>Control Condition</arm_group_label>
    <arm_group_label>PARENTCORPS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrollment in Pre-K&#xD;
&#xD;
          -  At least one English-Speaking caregiver&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laurie Brotman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine, The Child Study Center</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>
  <reference>
    <citation>Brotman LM, Calzada E, Huang KY, Kingston S, Dawson-McClure S, Kamboukos D, Rosenfelt A, Schwab A, Petkova E. Promoting effective parenting practices and preventing child behavior problems in school among ethnically diverse families from underserved, urban communities. Child Dev. 2011 Jan-Feb;82(1):258-76. doi: 10.1111/j.1467-8624.2010.01554.x.</citation>
    <PMID>21291441</PMID>
  </reference>
  <results_reference>
    <citation>Brotman LM, Dawson-McClure S, Huang KY, Theise R, Kamboukos D, Wang J, Petkova E, Ogedegbe G. Early childhood family intervention and long-term obesity prevention among high-risk minority youth. Pediatrics. 2012 Mar;129(3):e621-8. doi: 10.1542/peds.2011-1568. Epub 2012 Feb 6.</citation>
    <PMID>22311988</PMID>
  </results_reference>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EARLY CHILDHOOD</keyword>
  <keyword>UNIVERSAL PREVENTION</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Problem Behavior</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/NCT01670227
org study id: 5R01MH77331-2
secondary id: R01MH077331
secondary id: R305F050245
nct id: NCT01670227
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study was to determine whether ParentCorps promotes academic achievement
      and prevents mental health problems in children living in disadvantaged urban communities
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Change from baseline in Academic achievement through Year 4
time frame: Assessed twice per year in Years 1 and 2, and then annually through Year 4
description: Academic achievement test scores assessed via the Kaufman Test of Educational Achievement (KTEA)
measure: Change from baseline in Child behavior at school through Year 4
time frame: Assessed twice per year in Years 1 and 2, and then annually through Year 6
description: Masked observations of child behavior at school
measure: Change from baseline Academic performance through Year 4
time frame: Assessed twice per year in Years 1 and 2, and then annually through Year 6
description: Teacher and parent ratings of academic performance
measure: Change from baseline Behavior through Year 4
time frame: Assessed twice per year in Years 1 and 2, and then annually through Year 6
description: Teacher and parent ratings of behavior
measure: Change from baseline Parent engagement in school through Year 4
time frame: Assessed twice per year in Years 1 and 2, and then annually through Year 6
description: Teacher rating of parent engagement in school
measure: Change from baseline Positive behavior support through Year 4
time frame: Assessed twice per year in Years 1 and 2
description: Parent report of positive behavior support
measure: Change from baseline Classroom climate and positive behavior support through Year 4
time frame: Assessed twice per year in Years 1 and 2, and then annually through Year 4
description: Masked observations of classroom climate and positive behavior support
arm group label: PARENTCORPS
arm group type: Experimental
description: ParentCorps is a school-based, family-focused universal intervention designed to attenuate the multiple risks associated with urban poverty, on children's health and development
arm group label: Control Condition
arm group type: Other
description: No intervention
intervention type: Behavioral
intervention name: PARENTCORPS
description: ParentCorps is a culturally-informed, universal intervention (for all children enrolled in Pre-K within an elementary school) designed to promote positive behavioral supports for children at home and in the classroom. ParentCorps includes two complementary components: 1) parent and child group intervention (13 2-hour sessions after school) for Pre-K students and their families; 2) professional development and individual consultation for early childhood teachers.
arm group label: Control Condition
arm group label: PARENTCORPS
criteria: 
gender: All
minimum age: 4 Years
maximum age: N/A
healthy volunteers: No
last name: Laurie Brotman, PhD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
citation: Brotman LM, Calzada E, Huang KY, Kingston S, Dawson-McClure S, Kamboukos D, Rosenfelt A, Schwab A, Petkova E. Promoting effective parenting practices and preventing child behavior problems in school among ethnically diverse families from underserved, urban communities. Child Dev. 2011 Jan-Feb;82(1):258-76. doi: 10.1111/j.1467-8624.2010.01554.x.
PMID: 21291441
citation: Brotman LM, Dawson-McClure S, Huang KY, Theise R, Kamboukos D, Wang J, Petkova E, Ogedegbe G. Early childhood family intervention and long-term obesity prevention among high-risk minority youth. Pediatrics. 2012 Mar;129(3):e621-8. doi: 10.1542/peds.2011-1568. Epub 2012 Feb 6.
PMID: 22311988
responsible party type: Sponsor
mesh term: Problem Behavior