Families, Children and Teachers Thriving Together

Social Anxiety Clinical Trial

Official title:

Families, Children and Teachers Thriving Together

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04276363
• Other study ID #: 19-00707
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 14, 2019
• Est. completion date: August 31, 2026

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3300
• Est. completion date: August 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emotional Stress
• Social Anxiety

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Score on Receptive One-Word Picture Vocabulary Test (ROWPVT)	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.	84 Months
Primary	Score on Dimensional Change Card Sort (DCCS) Assessment	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.	84 Months
Primary	Score on Pencil Tap Assessment	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.)	84 Months
Primary	Score on Parental Engagement of Families Questionnaire (PEFL)	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	84 Months
Secondary	Score on Assessment of Children's Emotional Skills (ACES)	Children are presented with a series of photographs of children making happy, sad, mad, scared, or ambiguous facial expressions. For each photograph, children are asked to name the emotion expressed in the face. The higher the score indicates higher ability to match emotions.	84 months
Secondary	Score on Emotion Recognition Questionnaire (ERQ)	16 scenarios that elicit happy, sad, mad, or scared emotions are presented to children, along with black and white line drawings to aid with comprehension (e.g. Johnny's little brother broke his toy on purpose). Children are asked to name the emotion the main character would be feeling in that situation. Scores are reported as the proportion of correct matches out of 16 (i.e. 1/16, 2/16, etc.)	84 months
Secondary	Score on Patient Health Questionnaire (PHQ-9)	Four items are rated on a 4-point scale, ranging from 0 = not at all to 3 = nearly every day.; This will be used to assess parent well-being.	84 months
Secondary	Score on Financial Stress Questionnaire	To examine the degree to which parents worry about their finances, 8 questions will be asked to form a composite measure of financial stress. Parents respond to each item on a 5-point Likert scale. 5 indicates a high level of financial stress.	84 months
Secondary	Score on PROMIS-10 Survey	10-item survey that assess general parent well-being. Participants are asked to respond on a 5-point scale, ranging from 1 (poor) to 5 (excellent)	84 months
Secondary	Score on PROMIS-4 Sleep Disturbance Survey	This is a 4-item questionnaire assessing the quality of adult sleep. Participants are asked to respond on a 5-point scale ranging from 1 (not at all) to 5 (very much) to questions regarding their sleep quality.	84 months