Executive Function in Early Childhood

Vanderbilt University

Status: Enrolling

Conditions: Reading Disability

Treatments: Behavioral: Reading Tutoring

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03713125

1R37HD095519-01A1 (U.S. NIH Grant/Contract)

181739

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 4 to 9 years old

Volunteers: Accepts Healthy Volunteers

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, with the exception of stimulant medication for ADHD.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 2 patient groups

Reading Tutoring Intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Reading Tutoring

Business as Usual

No Intervention group

Description:

Instruction as usual within schools