Families, Children and Teachers Thriving Together

April 16, 2026 updated by: NYU Langone Health
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This randomized controlled trial is an evaluation of Thrive Professional Learning plus ParentCorps compared to the Thrive and Inspire Professional Learning tracks in 81 district schools. The study will include families of Pre-K students and Pre-K students. Forty-one (41) district schools are participating in Thrive Professional Learning, delivered by NYU Langone-based staff; 20 of these schools are randomly assigned to implement ParentCorps (in addition to Thrive Professional Learning). Forty (40 district schools) are participating in Inspire Professional Learning and will not implement ParentCorps.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
458

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Thrive Professional Learning plus ParentCorps
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
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.
Experimental: Thrive Professional Learning only
Parents with a child enrolled at a participating school with teachers who received the thrive professional learning only.
Behavioral: Thrive Professional Learning only
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.
Experimental: Inspire Professional Learning
Parents with a child enrolled at a participating school with teachers who received the inspire professional learning only.
Behavioral: Inspire Professional Learning
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
NIH Toolbox Emotion Battery Test Anger Subscale Score
Time Frame: End of Kindergarten, on average 22 months
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
Time Frame: End of Kindergarten, on average 22 months
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
Time Frame: End of Kindergarten, on average 22 months
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
Time Frame: End of Pre-Kindergarten, on average 9 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NIH Toolbox Emotion Battery Test Score
Time Frame: End of Kindergarten, on average 22 months
Parents report on three sub-scales from the NIH Toolbox Emotion Battery. This measure was designed for children ages 3 - 7. The Fear-Over Anxious subscale includes 6 items measuring symptoms of anxiety that reflect autonomic arousal and perceptions of threat. The Fear-Separation Anxiety subscale includes 7 items measuring symptoms of anxiety that reflect autonomic arousal and perceptions of threat. The Sadness subscale includes 7 items measuring low levels of positive affect. Parents are asked to respond to items on a three-point scale ranging from "Never True" to "Often True". All subscales are summed for a total score. The NIH Toolbox uses a T-score metric where a score of 50 is the mean and 10 is the standard deviation. The average of the three sub-scales is calculated. A higher T-score indicates higher anxiety, separation anxiety and sadness.
End of Kindergarten, on average 22 months
PROMIS-4 Sleep Disturbance Questionnaire Score
Time Frame: End of Kindergarten, on average 22 months
Parents report on the Patient-Reported Outcomes Measurement Information System (PROMIS) -4 sleep disturbance questionnaire. This 4-item questionnaire assesses child's sleep disturbances. Parents report on a 5-point scale ranging from "Never" to "Always". Scores are converted to a T-score, where a score of 50 is the mean and 10 is the standard deviation. Higher T-scores reflect high sleep disturbance.
End of Kindergarten, on average 22 months
Parent Evidence-Based Strategies Scale
Time Frame: End of Pre-Kindergarten, on average 9 months
Parents report on the Parent Evidence-Based Strategies Scale, which is adapted from the Parent Practices Interview (PPI). This 6-item scale assesses the frequency in which parents apply a range of evidence-based parenting strategies (e.g., behavioral management, promotion strategies). Parents report on a 5-point scale, ranging from 1 (Never) to 5 (Very Often). Items are scored for a total score, scores range from 6-30. Higher scores reflect higher frequency of evidence-based strategies in parenting.
End of Pre-Kindergarten, on average 9 months
Daily Living Routines Subscale of the Child Routines Inventory (CRI) Score
Time Frame: End of Kindergarten, on average 22 months
Parents report on the Daily Living Routines subscale of the Child Routines Inventory (CRI). This measures commonly occurring routines in school-aged children. This 11-item subscale consists of routines around activities of daily living, such as morning routine and bedtime routine. Parents report on a 5-point scale, ranging from "Almost Never" to "Nearly Always". Scores are summed and range from 0-44, with high scores reflecting higher frequency of routines related to daily activities.
End of Kindergarten, on average 22 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child body mass index (BMI)
Time Frame: 84 months
Children's height and weight will be measured in order to calculate BMI. The height will be measured using a stadiometer, and the weight will be measured using an electronic scale.
84 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laurie Brotman, PhD, New York Langone Health

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-00707
  • 5R01HD106547-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing 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.

IPD Sharing Access Criteria

Requests should be directed to Andrea.Troxel@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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