Executive Function in Early Childhood

Last updated: August 8, 2025
Sponsor: Vanderbilt University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dyslexia

Learning Disorders

Treatment

Reading Tutoring

Clinical Study ID

NCT03713125
181739
1R37HD095519-01A1
  • Ages 4-9
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Children in Kindergarten (approximate ages 4-9 years)

  2. Native English speakers

Exclusion

Exclusion Criteria:

  1. Children not in Kindergarten at time of enrollment;

  2. previous diagnosis of Intellectual Disability;

  3. known uncorrectable visual impairment;

  4. documented hearing impairment greater than or equal to a 25 decibel (dB) loss;

  5. medical contraindication to MRI procedures (e.g., metal devices) - excludes from MRIprocedures only;

  6. known intelligence quotient (IQ) below 70;

  7. a pervasive developmental disorder; and

  8. any known neurologic pathology, including epilepsy, spina bifida, cerebral palsy,traumatic brain injury, and brain tumors.

  9. Comorbid severe psychiatric disorders will also be excluded, as will those who aretaking psychotropic medications, with the exception of stimulant medication forAttention Deficit Hyperactivity Disorder (ADHD). Children who meet criteria for ADHDwill be eligible as long as they are not taking psychotropic medications, with theexception of stimulant medication for ADHD.

Study Design

Total Participants: 260
Treatment Group(s): 1
Primary Treatment: Reading Tutoring
Phase:
Study Start date:
August 13, 2019
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • Vanderbilt University

    Nashville, Tennessee 37240
    United States

    Active - Recruiting

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