Clinical Trials Directory

Trials / Recruiting

RecruitingNCT03713125

Executive Function in Early Childhood

Early Academic Achievement and Intervention Response: Role of Executive Function

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
260 (estimated)
Sponsor
Vanderbilt University · Academic / Other
Sex
All
Age
4 Years – 9 Years
Healthy volunteers
Accepted

Summary

Despite the fact that a substantial number of school age children struggle with both reading and math acquisition, the brain mechanisms of the overlapping aspects of reading and math skills, thought in part to be linked via executive functions (EF), have not been unpacked. This project will use a longitudinal design, following children from Kindergarten through 1st grade, to understand how the brain networks associated with reading, math, and EF interact to predict academic outcomes and, in those who struggle academically, intervention response.

Detailed description

This longitudinal study will be conducted with 260 Kindergartners, staggered across multiple cohorts, who are followed through 1st grade. There will be three time points of testing for each cohort: fall of Kindergarten, spring of Kindergarten, and in the fall of 1st grade. After the third testing time point, in the fall of 1st grade, the bottom 1/3 of readers in the sample will be selected to participate in the intervention arm of the study. These students will be randomly placed in one of two arms: business-as-usual, in which children receive no additional instruction; or the reading intervention condition, in which they receive 20 hours of 1:1 reading intervention over 6 weeks. Children in both sub-sample arms are assessed again after tutoring is complete, in the spring of 1st grade. Neuroimaging through magnetic resonance imaging (MRI) and functional magnetic resonance imaging (fMRI) will occur as part of study participation in conjunction with testing at fall of Kindergarten, fall of 1st grade, and spring of 1st grade time points.

Conditions

Interventions

TypeNameDescription
BEHAVIORALReading Tutoring20 hours of 1:1 reading tutoring intervention over 6 weeks

Timeline

Start date
2019-08-13
Primary completion
2026-07-31
Completion
2026-07-31
First posted
2018-10-19
Last updated
2025-08-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03713125. Inclusion in this directory is not an endorsement.