Clinical trial NCT03713125: Executive Function in Early Childhood
Official title: Early Academic Achievement and Intervention Response: Role of Executive Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Reading Disability
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-10-19
Enrollment: 260
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed 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.

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, with the exception of stimulant medication for ADHD.

Primary outcomes:
measure: Woodcock Johnson Tests of Achievement, Fourth Edition (WJ-IV)
timeFrame: Baseline, at study entry (Fall of Kindergarten)
measure: Change in Woodcock Johnson Tests of Achievement, Fourth Edition (WJ-IV)
timeFrame: Baseline, at study entry (Fall of Kindergarten); and approximately 1 year after baseline (Fall of 1st Grade)
measure: Change in Woodcock Johnson Tests of Achievement, Fourth Edition (WJ-IV)
timeFrame: Approximately 1 year after baseline (Fall of 1st Grade); and approximately 1 year 3 months after baseline (Spring of 1st Grade)
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Laurie E Cutting, PhD
role: PRINCIPAL_INVESTIGATOR
References: