dbGaP Study Accession: phs002661

NIH Institute/Center: NICHD

RADx Data Program: RADx-UP

DOI: 10.60773/6kbx-7v76

Release Date: 08/31/2023

Study Description: The overarching goal of this study was to determine the acceptability, feasibility, efficacy, and scalability of back-to-early childhood education (ECE) testing in young children (3-5 years). Whether outdoor garden-based education can help close the education gap experienced by children who have been out of school during the pandemic will also be determined. The subject population was comprised of three groups of people: (1) ECE-enrolled children, (2) their parents, and (3) ECE personnel. The enrollment goal for this study was ~800 children between the ages of 3 and 5, with the average age of 4 years to be evenly distributed by sex from 40 ECE sites in Phoenix, Maricopa County, AZ. One parent of each child, most of whom (~90%) will be women, were also enrolled. It was expected that most children and parents in the sample will be Hispanic and many to be Spanish language dominant. Approximately 40 ECE personnel were enrolled. An additional 800 child and parent dyads were recruited.

Updated Date: 04/17/2024

Principal Investigator: Lee, Rebecca Elizabeth

Has Data Files: Yes

Study Domain: COVID in School Settings

Data Collection Method: Survey

Keywords: School-aged Children/Young Adults; Families/Legal Guardians of School-aged Children/Young Adults

Study Design: Longitudinal Cohort

Multi-Center Study: FALSE

Data Types: Behavioral; Other; Questionnaires/Surveys; Clinical

Data Types, Other: Data derived from self-report surveys measuring the CDCC RADxUP Tier 1 common data elements; Information will be de-identified; Information from COVID-19 saliva tests (e.g., date, result) included

Study Start Date: 07/01/2021

Study End Date: 06/30/2023

Species: Human Data

Estimated Cohort Size: 627

Study Population Focus: School Community Members; Children; Hispanic and Latino

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05178290

Publication URL: https://pubmed.ncbi.nlm.nih.gov/37394507/; https://pubmed.ncbi.nlm.nih.gov/37394512/; https://pubmed.ncbi.nlm.nih.gov/36471388/; https://pubmed.ncbi.nlm.nih.gov/37394503/

Acknowledgement Statement: This study was supported through funding, 3OT2HD108101-01S1, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-UP program. The project would like to acknowledge the investigators, staff, students, and trainees who worked tirelessly to complete this project. The research team is grateful for the time and support of our community partners and research participants. Approved users should acknowledge the provision of data access by dbGaP for accession phs002661.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

NIH Grant or Contract Number(s): 3OT2HD108101-01S1

Consent/Data Use Limitations: General Research Use