Families, Children and Teachers Thriving Together

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: Completed
• Conditions: Child Mental Health
• Intervention / Treatment: Behavioral: Thrive Professional Learning plus ParentCorps; Behavioral: Thrive Professional Learning only; Behavioral: Inspire Professional Learning

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: Interventional
• Enrollment (Actual): 458
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIH Toolbox Emotion Battery Test Score	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Child body mass index (BMI)	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

• Sponsor: NYU Langone Health
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Laurie Brotman, PhD, New York Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2019
• Primary Completion (Actual): September 6, 2021
• Study Completion (Actual): September 6, 2021

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID 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