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Clinical Trials/NCT04276363
NCT04276363
Active, not recruiting
Not Applicable

Families, Children and Teachers Thriving Together

NYU Langone Health1 site in 1 country491 target enrollmentNovember 14, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Social Anxiety
Sponsor
NYU Langone Health
Enrollment
491
Locations
1
Primary Endpoint
Score on Parental Engagement of Families Questionnaire (PEFL)
Status
Active, not recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 14, 2019
End Date
August 31, 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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:
  • 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-
  • 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.

Outcomes

Primary Outcomes

Score on Parental Engagement of Families Questionnaire (PEFL)

Time Frame: 84 Months

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

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

Time Frame: 84 Months

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.

Score on Dimensional Change Card Sort (DCCS) Assessment

Time Frame: 84 Months

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.

Score on Pencil Tap Assessment

Time Frame: 84 Months

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.)

Secondary Outcomes

  • 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 PROMIS-4 Sleep Disturbance Survey(84 months)
  • Score on Financial Stress Questionnaire(84 months)
  • Score on PROMIS-10 Survey(84 months)

Study Sites (1)

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