Actively Recruiting

Phase Not Applicable
Age: 4Years - 9Years
All Genders
Healthy Volunteers
ID03713125

Early Academic Achievement and Intervention Response: Role of Executive Function

Led by Vanderbilt University ยท Updated on 2025-08-14

260

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

V

Vanderbilt University

Lead Sponsor

E

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how brain networks related to reading, math, and executive functions interact to predict academic outcomes in children. This longitudinal study focuses on kindergartners followed through first grade to understand overlapping skills and responses to intervention in those who struggle with reading and math. The study aims to explore these brain mechanisms to better support children facing academic challenges. The study involves 260 kindergartners tested at three time points: fall and spring of kindergarten, and fall of first grade. After the third assessment, the lowest third of readers will be randomly assigned to either continue usual instruction or receive 20 hours of one-on-one reading tutoring over six weeks. Both groups will be reassessed in the spring of first grade. Brain imaging using MRI and fMRI will be done at fall of kindergarten, fall of first grade, and spring of first grade to examine brain activity related to learning. Participants will complete academic testing with the Woodcock Johnson Tests of Achievement at baseline and follow-up points to measure reading and math skills. The study tracks changes over time and intervention effects. Children will participate in assessments, neuroimaging, and tutoring sessions as applicable. The total study duration spans from kindergarten entry through spring of first grade, with multiple evaluations to monitor progress and brain function.

CONDITIONS

Brief Title

Executive Function in Early Childhood

Who Can Participate

Age: 4Years - 9Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children in Kindergarten (approximately ages 4 to 9 years)
  • Native English speakers
Not Eligible

You will not qualify if you...

  • 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 25 decibels
  • Medical contraindication to MRI procedures (e.g., metal devices) excludes from MRI only
  • Known intelligence quotient (IQ) below 70
  • A pervasive developmental disorder
  • Any known neurologic pathology, including epilepsy, spina bifida, cerebral palsy, traumatic brain injury, and brain tumors
  • Comorbid severe psychiatric disorders
  • Taking psychotropic medications other than stimulant medication for ADHD

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 1 year

Participants complete testing and neuroimaging at three time points: fall of Kindergarten, spring of Kindergarten, and fall of 1st grade.

3 visits (in-person) including MRI and fMRI sessions

Treatment

Duration - 6 weeks

Participants in the bottom third of readers receive either 20 hours of one-on-one reading tutoring over 6 weeks or business-as-usual instruction.

Up to 20 tutoring sessions (in-person) or no additional visits for business-as-usual

Follow-up

Duration - Approximately 3 months

Participants in both intervention and business-as-usual groups are assessed again after tutoring is complete in the spring of 1st grade, including neuroimaging.

1 visit (in-person) including MRI and fMRI sessions

Trial Site Locations

Total: 1 location

1

Vanderbilt University

Nashville, Tennessee, United States, 37240

Actively Recruiting

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Research Team

J

Julie Delheimer, BS

L

Lanier P Sachs, M.Ed.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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