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ParentCorps: Promoting Healthy Development in Children From Low Income Communities (ParentCorps)

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ClinicalTrials.gov Identifier: NCT01670227
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : March 3, 2016
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
U.S. Department of Education
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE August 8, 2012
First Posted Date  ICMJE August 22, 2012
Last Update Posted Date March 3, 2016
Study Start Date  ICMJE September 2005
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2012)
  • 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 ]
    Academic achievement test scores assessed via the Kaufman Test of Educational Achievement (KTEA)
  • 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 ]
    Masked observations of child behavior at school
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2012)
  • 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 ]
    Teacher and parent ratings of academic performance
  • Change from baseline Behavior through Year 4 [ Time Frame: Assessed twice per year in Years 1 and 2, and then annually through Year 6 ]
    Teacher and parent ratings of behavior
  • 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 ]
    Teacher rating of parent engagement in school
  • Change from baseline Positive behavior support through Year 4 [ Time Frame: Assessed twice per year in Years 1 and 2 ]
    Parent report of positive behavior support
  • 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 ]
    Masked observations of classroom climate and positive behavior support
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ParentCorps: Promoting Healthy Development in Children From Low Income Communities
Official Title  ICMJE Preventing Conduct Problems in Poor Urban Preschoolers
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Behavior Problems of Childhood and Adolescence
Intervention  ICMJE Behavioral: PARENTCORPS
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.
Study Arms  ICMJE
  • Experimental: PARENTCORPS
    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
    Intervention: Behavioral: PARENTCORPS
  • Control Condition
    No intervention
    Intervention: Behavioral: PARENTCORPS
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2012)
1050
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Enrollment in Pre-K
  • At least one English-Speaking caregiver

Exclusion Criteria:

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01670227
Other Study ID Numbers  ICMJE 5R01MH77331-2
R01MH077331 ( U.S. NIH Grant/Contract )
R305F050245 ( Other Grant/Funding Number: U.S. Department of Education )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • U.S. Department of Education
Investigators  ICMJE
Principal Investigator: Laurie Brotman, PhD NYU Langone Health
PRS Account NYU Langone Health
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP