NCT04276363

Brief Summary

The current study examines the impact of ParentCorps in high-poverty district schools in New York City (NYC). The study is conducted within the context of the NYC Department of Education (DOE) Pre-K Thrive initiative. As part of this initiative, the Center for Early Childhood Health and Development (CEHD) at NYU Langone Health is implementing services to strengthen family engagement and support parents and teachers in creating safe, nurturing and predictable environments for young children. All parents of Pre-K students in the 81 district schools will be invited for them and their Pre-K children to participate in the study, which includes 2 school-based assessments in Pre-K over a 10-month period and 1 school-based assessment at the end of Kindergarten, and teacher ratings of children in Pre-K and Kindergarten. Additionally, parents will be invited to consent to the use of their children's NYC DOE administrative records from Pre-K through grade 5 for the purposes of this study. Parents will also be invited to participate by completing surveys with NYU study staff. Parents will be consented to complete two surveys when their child is in Pre-K. Parents may be randomly selected to complete a third survey when their child is in Kindergarten or to participate in a focus group with other parents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
458

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 14, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2021

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

May 7, 2026

Completed
Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

October 2, 2019

Results QC Date

October 17, 2025

Last Update Submit

April 16, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • NIH Toolbox Emotion Battery Test Anger Subscale Score

    Parents report on the Anger subscale from the NIH Toolbox Emotion Battery. This measure was designed for children ages 3 - 7. The Anger subscale includes 9 items which measure attitudes of hostility and cynicism often associated with experiences of frustration impeding goal-directed behavior. Parents are asked to respond to items on a three-point scale ranging from "Never True" to "Often True". The NIH Toolbox uses a T-score metric where a score of 50 is the mean and 10 is the standard deviation. A higher T-score indicates higher anger.

    End of Kindergarten, on average 22 months

  • Pediatric Symptom Checklist (PSC) Score

    Parents report on Attention Problems on the PSC. Tis 5-item subscale screens psychosocial functioning in children 4-18 years of age. Parents are asked to rate the frequency of each symptom on a three-point scale ranging from "Never" (0) to "Often" (2). Scores are summed and range from 0-10, with higher scores indicating high attention problems.

    End of Kindergarten, on average 22 months

  • Social Competence Scale - Parent Version Score

    Parents report on two subscales, Prosocial/Communication Skills and Emotional Regulation Skills, on the Social Competence Scale. This 12-item measure assesses a child's prosocial behaviors, communication skills, and self-control. Parents respond to items on a five-point scale ranging from "Not at All" to "Very well". Scores are summed on both subscales for a total scale score, scores range from 0 to 48. Higher scores reflect higher parent-reported social competence.

    End of Kindergarten, on average 22 months

  • The Parental Engagement of Families Questionnaire (PEFL) Score

    Parents report on the Foundational Education sub-scale of the Parental Engagement of Families Questionnaire (PEFL). This measure captures parental engagement designed for and validated with Latino Head Start families. The 20-item Foundational Education sub-scale reflects parents' efforts to teach their children "the basics". Parents respond to each item using a 4-point rating scale ranging from 1 (Never) to 4 (Frequently). Raw summed scores are converted to T-scores where a score of 50 is the mean and 10 is the standard deviation. Higher scores indicates higher parent-reported social competence.

    End of Pre-Kindergarten, on average 9 months

Secondary Outcomes (4)

  • NIH Toolbox Emotion Battery Test Score

    End of Kindergarten, on average 22 months

  • PROMIS-4 Sleep Disturbance Questionnaire Score

    End of Kindergarten, on average 22 months

  • Parent Evidence-Based Strategies Scale

    End of Pre-Kindergarten, on average 9 months

  • Daily Living Routines Subscale of the Child Routines Inventory (CRI) Score

    End of Kindergarten, on average 22 months

Study Arms (3)

Thrive Professional Learning plus ParentCorps

EXPERIMENTAL

Parents with a child enrolled at a participating school with teachers who received the thrive professional learning plus ParentCorps.

Behavioral: Thrive Professional Learning plus ParentCorps

Thrive Professional Learning only

EXPERIMENTAL

Parents with a child enrolled at a participating school with teachers who received the thrive professional learning only.

Behavioral: Thrive Professional Learning only

Inspire Professional Learning

EXPERIMENTAL

Parents with a child enrolled at a participating school with teachers who received the inspire professional learning only.

Behavioral: Inspire Professional Learning

Interventions

Delivered to leaders in groups of 20 - 40 three times a year over the same two-year period. Content covers best practices in Family Engagement and Social Emotional Learning and includes an experiential approach to behavior change that asks learners to take the perspective of others and consider their own beliefs and assumptions about students, families, teachers and leaders

Inspire Professional Learning

led by the NYC Department of Education. Professional Learning sessions are tailored to the needs of pre-K teachers and leaders, and include topics aligned with the district's quality standards that support child instructional goals.

Thrive Professional Learning plus ParentCorps

Part of the Professional Learning Track system for all Pre-K for All teachers and leaders. The NYC DOE schedules Thrive Professional Learning training days for staff on non-attendance days. Teachers attend four Professional Learning days annually, and leaders attend three days annually, over a two-year period.

Thrive Professional Learning only

Eligibility Criteria

Age4 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pre-K students and families who attend one of the 81 district schools in 2019-2020.
  • Only parents and students who are English or Spanish speaking will be eligible for participation in the study.

You may not qualify if:

  • Families in sites other than the 81 district schools randomized to this study are excluded.
  • Parents or students who do not speak English and/or Spanish will not be eligible to participate.
  • Teachers and principals from the 81 sites are not considered participants in the study of student and family outcomes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Results Point of Contact

Title
Laurie Miller Brotman, Ph.D.
Organization
NYU Langone Health

Study Officials

  • Laurie Brotman, PhD

    New York Langone Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2019

First Posted

February 19, 2020

Study Start

November 14, 2019

Primary Completion

September 6, 2021

Study Completion

September 6, 2021

Last Updated

May 7, 2026

Results First Posted

May 7, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
Requests should be directed to Andrea.Troxel@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations