Behavior Problems of Childhood and AdolescenceParentCorpsNCT01670227
ParentCorps: Promoting Healthy Development in Children From Low Income Communities
A study testing PARENTCORPS in people with Behavior Problems of Childhood and Adolescence, run by NYU Langone Health at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Behavior Problems of Childhood and Adolescence
- What is being tested?
- PARENTCORPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Enrollment in Pre-K
- At least one English-Speaking caregiver
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine, The Child Study Center
New York, New York, 10016
About this study
Official title: 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
- Being tested
- PARENTCORPS
- Keywords
- EARLY CHILDHOOD, UNIVERSAL PREVENTION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARENTCORPSBehavioural
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 group | Role | What they receive |
|---|---|---|
| PARENTCORPS | Experimental | 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 Receives: Behavioral: PARENTCORPS |
| Control Condition | Other | No intervention Receives: Behavioral: PARENTCORPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Academic achievement through Year 4
Academic achievement test scores assessed via the Kaufman Test of Educational Achievement (KTEA)
Measured: Assessed twice per year in Years 1 and 2, and then annually through Year 4
Change from baseline in Child behavior at school through Year 4
Masked observations of child behavior at school
Measured: Assessed twice per year in Years 1 and 2, and then annually through Year 6
Secondary outcomes (5)
Change from baseline Academic performance through Year 4
Teacher and parent ratings of academic performance
Measured: Assessed twice per year in Years 1 and 2, and then annually through Year 6
Change from baseline Behavior through Year 4
Teacher and parent ratings of behavior
Measured: 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
Teacher rating of parent engagement in school
Measured: Assessed twice per year in Years 1 and 2, and then annually through Year 6
Change from baseline Positive behavior support through Year 4
Parent report of positive behavior support
Measured: Assessed twice per year in Years 1 and 2
Change from baseline Classroom climate and positive behavior support through Year 4
Masked observations of classroom climate and positive behavior support
Measured: Assessed twice per year in Years 1 and 2, and then annually through Year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startSep 2005
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Behavior Problems of Childhood and AdolescenceStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), U.S. Department of Education
- Responsible party
- Sponsor
- Investigators
- Laurie Brotman, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670227
- Sponsor's protocol ID
- 5R01MH77331-2
- Other IDs
- R01MH077331, R305F050245
- Acronym
- ParentCorps
- Status last verified
- Mar 2016
- First submitted
- 8 Aug 2012
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21291441Brotman 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.
PubMed 22311988Brotman 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.
PubMed 27695851Brotman 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.
PubMed 23589806
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Conduct Problems in Poor Urban Preschoolers
- ClinicalTrials.gov ID
- NCT01670227
- Acronym / sponsor ID
- ParentCorps / 5R01MH77331-2
- Keywords
- EARLY CHILDHOOD, UNIVERSAL PREVENTION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), U.S. Department of Education
- Study start
- Sep 2005
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PARENTCORPS | Experimental | Behavioral: PARENTCORPSParentCorps is a school-based, family-focused universal intervention designed to attenuate the multiple risks associated with urban poverty, on children's health and development |
| Control Condition | Other | Behavioral: PARENTCORPSNo intervention |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Enrollment in Pre-K
- At least one English-Speaking caregiver
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PARENTCORPSParentCorps 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. | Behavioural | Control Condition, PARENTCORPS |
Primary outcome
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
5 secondary outcomes
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
Change from baseline Behavior through Year 4
Time frame: 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
Change from baseline Positive behavior support through Year 4
Time frame: Assessed twice per year in Years 1 and 2
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 21291441Brotman 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.
- Results publication: PubMed 22311988Brotman 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.
- Derived from this study: PubMed 27695851Brotman 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.
- Derived from this study: PubMed 23589806Brotman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie Brotman, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PARENTCORPS in people with Behavior Problems of Childhood and Adolescence, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01670227, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.