Executive Function in Early Childhood

NCT03713125 | Recruiting

• 2 other identifiers: 1817391R37HD095519-01A1
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Reading Disability

Outcome Measures

Primary Outcomes (3)

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

  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.

  Baseline, at study entry (Fall of Kindergarten)

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

  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).

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

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

  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).

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

Study Arms (2)

Reading Tutoring Intervention

ACTIVE COMPARATOR

20 hours of one-on-one reading tutoring administered over 6 weeks

Behavioral: Reading Tutoring

Business as Usual

NO INTERVENTION

Instruction as usual within schools

Interventions

Reading Tutoring BEHAVIORAL

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

Reading Tutoring Intervention

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37240, United States

RECRUITING

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

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

Study Officials

• Laurie E Cutting, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Delheimer, BS

CONTACT

615-875-5534; educationbrain@vanderbilt.edu

Lanier P Sachs, M.Ed.

CONTACT

615-936-1167

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 19, 2018
• Study Start: August 13, 2019
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)