Clinical trial NCT04276363: Families, Children and Teachers Thriving Together
Official title: Families, Children and Teachers Thriving Together
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Social Anxiety
Emotional Stress
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 491
Sex: ALL
Minimum age (years): 4
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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:

1. have 2 or more PKFA classrooms;
2. serve a high-need population and
3. 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.

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.

Primary outcomes:
measure: Score on Receptive One-Word Picture Vocabulary Test (ROWPVT)
timeFrame: 84 Months
measure: Score on Dimensional Change Card Sort (DCCS) Assessment
timeFrame: 84 Months
measure: Score on Pencil Tap Assessment
timeFrame: 84 Months
measure: Score on Parental Engagement of Families Questionnaire (PEFL)
timeFrame: 84 Months
Secondary outcomes:
measure: Score on Assessment of Children's Emotional Skills (ACES)
timeFrame: 84 months
measure: Score on Emotion Recognition Questionnaire (ERQ)
timeFrame: 84 months
measure: Score on Patient Health Questionnaire (PHQ-9)
timeFrame: 84 months
measure: Score on Financial Stress Questionnaire
timeFrame: 84 months
measure: Score on PROMIS-10 Survey
timeFrame: 84 months
measure: Score on PROMIS-4 Sleep Disturbance Survey
timeFrame: 84 months
Other outcomes:
measure: Child body mass index (BMI)
timeFrame: 84 months
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Health
name: Laurie Brotman, MD
role: PRINCIPAL_INVESTIGATOR
References: