ClinicalTrials.gg
Enrolling by invitationNCT03713125Updated Aug 14, 2026

Executive Function in Early Childhood

An interventional study of Reading Tutoring in Reading Disability, sponsored by Vanderbilt University. Enrolling by invitation at 1 site in United States. Open to participants aged 4 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Vanderbilt University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
4 Years to 9 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Reading Disability

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03

In context

Dyslexia

127 studies on the registry are indexed under Dyslexia; 27 are open to participants now.

This study's planned enrollment of 260 is above the median of 71 across 106 interventional studies indexed under Dyslexia.

Browse Dyslexia studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 522 studies on the registry; 20 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Children in Kindergarten (approximate ages 4-9 years)
  2. Native English speakers

Exclusion criteria

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
260 participants (estimated)

Study arms

  • Active comparator
    Reading Tutoring Intervention

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

    Behavioral: Reading Tutoring

  • No intervention
    Business as Usual

    Instruction as usual within schools

Interventions

  • BehavioralReading Tutoring

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, at study entry (Fall of Kindergarten)

  2. 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).

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

  3. 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).

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2019 (actual). Primary completion is estimated for Jul 2029, 119 months after the start.

Of 62 non-industry interventional studies with no phase under Dyslexia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 57. This study's planned 119 months is above that.

Counting every sponsor, half of 69 studies reached it within 24 months; a quarter within 9 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2018
First posted
Oct 19, 2018
StartActual
Aug 13, 2019
Primary completionEst.
Jul 31, 2029
CompletionEst.
Jul 31, 2030
Last update
Aug 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03713125
Responsible party
Laura Cutting (Principal Investigator, Vanderbilt University) — Principal investigator
First posted
Oct 19, 2018
Start date
Aug 13, 2019
Primary completion
Jul 31, 2029 (estimated)
Completion
Jul 31, 2030 (estimated)
Last update
Aug 14, 2026

Study contacts

Laurie E Cutting, PhD
principal investigator · Vanderbilt University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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