Promoting Success for Pre-K Teachers, Families and Children

• ClinicalTrials.gov Identifier: NCT03524105
• Recruitment Status: Completed
• First Posted: May 14, 2018
• Last Update Posted: January 8, 2021
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Study Description

Brief Summary:

The current study examines the impact of ParentCorps in high-poverty Early Education Centers 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 building safe, nurturing and predictable environments for young children. Services include resources to support social emotional learning (SEL) and family engagement (FE) for all Pre-K for All (PKFA) programs and all PKFA families; Professional Learning to support the use of evidence-based SEL and FE practices for teachers and leaders from 350 PKFA programs; and ParentCorps programs for PKFA children and families in 50 PKFA programs (which is a subset of PKFA programs receiving Professional Learning). The current study evaluates the relative value of Thrive Professional Learning plus ParentCorps compared to Thrive Professional Learning.

This study will include 158 pre-K teachers (teachers and teaching assistants) across 23 Centers (12 Centers receiving Thrive Professional Learning plus ParentCorps, 11 Centers receiving Thrive Professional Learning only). All teachers in the 23 Centers will be invited to complete 2 self-report surveys over a two-year period. A sub-set of teachers will be randomly selected to participate in 2 interviews during this period. In addition, teachers in sites randomized to ParentCorps (12 Centers) will be invited to consent to the use of weekly implementation surveys, observational data and semi-structured interviews about experiences with implementation, collected as part of standard implementation practice of ParentCorps, for the purposes of this study.

Condition or disease	Intervention/treatment	Phase
Emotional Stress	Behavioral: Program for Parents (Parenting Program); Behavioral: Thrive Professional Learning	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 570 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Promoting Success for Pre-K Teachers, Families and Children
• Actual Study Start Date: September 17, 2018
• Actual Primary Completion Date: August 31, 2020
• Actual Study Completion Date: August 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Thrive Professional Learning plus ParentCorps	Behavioral: Program for Parents (Parenting Program); Program for Parents (Parenting Program) is implemented by a mental health professional and offered to groups of ~15 parents during the school day and during after school hours. The Program for Parents includes 2-hour sessions provided weekly over a 4-month period. The Program for Students (Friends School Social Emotional Learning Program) is implemented by classroom teachers in the classroom with 90 minute lessons and activities once a week for 14 weeks
Active Comparator: Thrive Professional Learning track	Behavioral: Thrive Professional Learning; Professional Learning is delivered to teachers in groups of 20-40 4 times a year over a two-year period. Professional Learning is delivered to leaders in groups of 20 - 40 three times a year over the same two-year period.

Outcome Measures

Primary Outcome Measures :

1. Teacher's knowledge measured using self- report surveys [ Time Frame: 15 Months ]
2. Teachers' social emotional competencies measured using the Emotion Regulation Questionnaire (ERQ) [ Time Frame: 15 Months ]
   The emotion regulation questionnaire is designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression on a 5 point scale

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Teachers who are teaching staff in the Pre-K classrooms in the 23 Centers.

Exclusion Criteria:

• Only Pre-K teachers from the 23 Centers will be invited to participate in the study. Leaders and other school staff from the Centers are excluded from the study.
• Family-level administrative data only on Pre-K families from the 12 Centers assigned to the Professional Learning plus ParentCorps condition will be obtained from the NYC DOE. Families in other sites are excluded from the request for family-level administrative data.

Contacts and Locations

Locations

United States, New York

NYU Langone Health

New York, New York, United States, 10016

Sponsors and Collaborators

NYU Langone Health

Investigators

• Principal Investigator: Laurie Brotman, MD; NYU Langone Health

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03524105
• Other Study ID Numbers: 17-01812
• First Posted: May 14, 2018
• Last Update Posted: January 8, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• 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: The investigator who proposed to use the data will have access to the data. To gain access, data requestors will need to sign a data access agreement.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NYU Langone Health:

Socio Economic Adversity; Child Development; Poverty; racial disparity; ethnic disparity