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Recruiting NCT03713125

NCT03713125 Executive Function in Early Childhood

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Clinical Trial Summary
NCT ID NCT03713125
Status Recruiting
Phase
Sponsor Vanderbilt University
Condition Reading Disability
Study Type INTERVENTIONAL
Enrollment 260 participants
Start Date 2019-08-13
Primary Completion 2026-07-31

Trial Parameters

Condition Reading Disability
Sponsor Vanderbilt University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 260
Sex ALL
Min Age 4 Years
Max Age 9 Years
Start Date 2019-08-13
Completion 2026-07-31
Interventions
Reading Tutoring

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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.

Eligibility Criteria

Inclusion Criteria: 1. Children in Kindergarten (approximate ages 4-9 years) 2. Native English speakers 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 MRI procedures 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 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, w

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