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

75
On Track

Trial Health Score

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

Enrollment
491

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress95%
Nov 2019Aug 2026

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
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

October 2, 2019

Last Update Submit

May 28, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Score on Receptive One-Word Picture Vocabulary Test (ROWPVT)

    A higher score indicates higher academic skills. The assessment will take 10-20 minutes - the assessor will state a word in English or Spanish, while the child is shown four images. The child must choose the image that represents the word the assessor said.

    84 Months

  • Score on Dimensional Change Card Sort (DCCS) Assessment

    Children are presented with a series of cards depicting images that vary along two dimensions: color and shape. Children are first asked to sort the cards by one dimension (color). After they do this for several trials, they are then asked to sort the cards by the other dimension (shape). Scores are reported as a binary "yes" or "no" - yes - child can shift to sorting by the second dimension accurately.

    84 Months

  • Score on Pencil Tap Assessment

    Children are asked to tap on a table twice with a pencil with the experimenter taps once, and once when the experimenter taps twice. Scores are reported as proportion of trials children answer correctly out of 16 (i.e. 1/16, 2/16, 3/16, etc.)

    84 Months

  • Score on Parental Engagement of Families Questionnaire (PEFL)

    The items from the PEFL questionnaire will be reported as 4-point rating scale (i.e. 1 - never, 2 - rarely, 3 - sometimes, 4 - frequently) to indicate frequency of parental engagement

    84 Months

Secondary Outcomes (6)

  • Score on Assessment of Children's Emotional Skills (ACES)

    84 months

  • Score on Emotion Recognition Questionnaire (ERQ)

    84 months

  • Score on Patient Health Questionnaire (PHQ-9)

    84 months

  • Score on Financial Stress Questionnaire

    84 months

  • Score on PROMIS-10 Survey

    84 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Child body mass index (BMI)

    84 months

Study Arms (3)

Thrive Professional Learning plus ParentCorps

EXPERIMENTAL

1\) Professional Development, Program Training and Coaching; 2) Program for Parents of Pre-K Students; and 3) Program for Pre-K Students. The three intervention components are expected to strengthen relationships and communication between parents and teachers and promote safe, nurturing and predictable environments, which contribute to child mental health and achievement.

Behavioral: Thrive Professional Learning plus ParentCorps

Thrive Professional Learning only

EXPERIMENTAL

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.

Behavioral: Thrive Professional Learning only

Inspire Professional Learning

EXPERIMENTAL

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.

Behavioral: Inspire Professional Learning

Interventions

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

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

Eligibility Criteria

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

You may qualify if:

  • Site Selection Criteria A total of 81 of these district schools with pre-K programs in high poverty NYC neighborhoods were selected for the study in late Spring 2017 by the NYC Department of Education (DOE), following a detailed methodology developed collaboratively by the NYC DOE and NYU Investigators.
  • Schools must meet the following criteria:
  • have 2 or more PKFA classrooms;
  • serve a high-need population and
  • leaders ranked Thrive or Inspire as a first or second preference for the school. Sites that were currently implementing ParentCorps at the time of the randomization were not eligible for the study.
  • Participant Selection Criteria
  • Pre-K students and families who are in the schools in 2018-2019.
  • 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

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Laurie Brotman, MD

    New York Langone Health

    PRINCIPAL INVESTIGATOR

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 (Estimated)

August 31, 2026

Last Updated

May 29, 2025

Record last verified: 2025-05

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