Understanding how executive function affects reading in young children
Early Academic Achievement and Intervention Response: Role of Executive Function
This study looks at how children's thinking skills affect their reading and math as they grow, and it will test a special reading program to see if it helps kids who are having trouble.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 4 Years to 9 Years |
| Sex | All |
| Sponsor | Vanderbilt University Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT03713125 on ClinicalTrials.gov |
What this trial studies
This longitudinal study follows 260 Kindergartners through 1st grade to explore the relationship between executive function, reading, and math skills. The research involves three testing time points and neuroimaging assessments using MRI and fMRI to analyze brain networks. After initial assessments, struggling readers will be randomly assigned to either a reading intervention or a control group receiving standard instruction. The goal is to predict academic outcomes and evaluate the effectiveness of targeted reading interventions.
Who should consider this trial
Good fit: Ideal candidates are Kindergarten children aged 4-9 who are native English speakers.
Not a fit: Patients with significant cognitive impairments, severe psychiatric disorders, or medical conditions contraindicating MRI procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved reading interventions for children with reading disabilities.
How similar studies have performed: Other studies have shown success in using neuroimaging to understand learning disabilities, making this approach promising but still relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nashville, Tennessee
- Vanderbilt University — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Laurie E Cutting, PhD — Vanderbilt University
- Study coordinator: Julie Delheimer, BS
- Email: educationbrain@vanderbilt.edu
- Phone: 615-875-5534
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.