- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01670227
ParentCorps: Promoting Healthy Development in Children From Low Income Communities (ParentCorps)
June 13, 2023 updated by: NYU Langone Health
Preventing Conduct Problems in Poor Urban Preschoolers
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
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1050
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10016
- New York University School of Medicine, The Child Study Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Enrollment in Pre-K
- At least one English-Speaking caregiver
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
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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.
|
Other: Control Condition
No intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Assessed twice per year in Years 1 and 2, and then annually through Year 4
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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
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Masked observations of child behavior at school
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Assessed twice per year in Years 1 and 2, and then annually through Year 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Assessed twice per year in Years 1 and 2, and then annually through Year 6
|
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
|
Assessed twice per year in Years 1 and 2, and then annually through Year 6
|
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
|
Assessed twice per year in Years 1 and 2, and then annually through Year 6
|
Change from baseline Positive behavior support through Year 4
Time Frame: Assessed twice per year in Years 1 and 2
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Parent report of positive behavior support
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Assessed twice per year in Years 1 and 2
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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
|
Assessed twice per year in Years 1 and 2, and then annually through Year 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laurie Brotman, PhD, NYU Langone Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Brotman LM, Dawson-McClure S, Kamboukos D, Huang KY, Calzada EJ, Goldfeld K, Petkova E. Effects of ParentCorps in Prekindergarten on Child Mental Health and Academic Performance: Follow-up of a Randomized Clinical Trial Through 8 Years of Age. JAMA Pediatr. 2016 Dec 1;170(12):1149-1155. doi: 10.1001/jamapediatrics.2016.1891.
- Brotman LM, Dawson-McClure S, Calzada EJ, Huang KY, Kamboukos D, Palamar JJ, Petkova E. Cluster (school) RCT of ParentCorps: impact on kindergarten academic achievement. Pediatrics. 2013 May;131(5):e1521-9. doi: 10.1542/peds.2012-2632. Epub 2013 Apr 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
August 8, 2012
First Submitted That Met QC Criteria
August 17, 2012
First Posted (Estimated)
August 22, 2012
Study Record Updates
Last Update Posted (Actual)
June 15, 2023
Last Update Submitted That Met QC Criteria
June 13, 2023
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01MH77331-2
- R01MH077331 (U.S. NIH Grant/Contract)
- R305F050245 (Other Grant/Funding Number: U.S. Department of Education)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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