Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03713125

Executive Function in Early Childhood

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Reading Disability Communication Disorders Dyslexia Language Disorders Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Specific Learning Disorder

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University

Nashville, Tennessee, 37240, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children in Kindergarten (approximate ages 4-9 years)
  • Native English speakers

Exclusion criteria

  • Children not in Kindergarten at time of enrollment;
  • previous diagnosis of Intellectual Disability;
  • known uncorrectable visual impairment;
  • documented hearing impairment greater than or equal to a 25 decibel (dB) loss;
  • medical contraindication to MRI procedures (e.g., metal devices) - excludes from MRI procedures only;
  • known intelligence quotient (IQ) below 70;
  • a pervasive developmental disorder; and
  • any known neurologic pathology, including epilepsy, spina bifida, cerebral palsy, traumatic brain injury, and brain tumors.
  • Comorbid severe psychiatric disorders will also be excluded, as will those who are taking psychotropic medications, with the exception of stimulant medication for Attention Deficit Hyperactivity Disorder (ADHD). Children who meet criteria for ADHD will be eligible as long as they are not taking psychotropic medications, with the exception of stimulant medication for ADHD.

Treatment and study plan

Reading Tutoring

Behavioral

20 hours of 1:1 reading tutoring intervention over 6 weeks

Primary outcomes

  1. Woodcock Johnson Tests of Achievement, Fourth Edition (WJ-IV)

    Time frame: Baseline, at study entry (Fall of Kindergarten)

    WJ-IV Letter Word Identification, Word Attack, and Passage Comprehension subtests will be administered in order to assess letter and word recognition accuracy, decoding accuracy and reading comprehension. WJ-IV Calculation and Applied Problems will be administered to assess number identification, basic numeracy skills, and math problem solving. To assess whether cognitive and/or neural metrics of executive function and neural metrics of academic achievement predict academic ability at the same time point.

  2. Change in Woodcock Johnson Tests of Achievement, Fourth Edition (WJ-IV)

    Time frame: Baseline, at study entry (Fall of Kindergarten); and approximately 1 year after baseline (Fall of 1st Grade)

    Change from baseline in reading (as measured by WJ-IV Letter Word Identification, Word Attack, and Passage Comprehension subtests) and math (as measured by WJ-IV Calculation and Applied Problems subtests).

  3. Change in Woodcock Johnson Tests of Achievement, Fourth Edition (WJ-IV)

    Time frame: Approximately 1 year after baseline (Fall of 1st Grade); and approximately 1 year 3 months after baseline (Spring of 1st Grade)

    Change from pre-intervention testing to post-intervention testing in reading (as measured by WJ-IV Letter Word Identification, Word Attack, and Passage Comprehension subtests) and math (as measured by WJ-IV Calculation and Applied Problems subtests).

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Delheimer, BS

CONTACT

[email protected]

615-875-5534

Lanier P Sachs, M.Ed.

CONTACT

615-936-1167

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Early Academic Achievement and Intervention Response: Role of Executive Function

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Oct 19, 2018
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.