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Executive Function in Early Childhood

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ClinicalTrials.gov Identifier: NCT03713125
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Laura Cutting, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Reading Disability Behavioral: Reading Tutoring Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Early Academic Achievement and Intervention Response: Role of Executive Function
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 31, 2028
Estimated Study Completion Date : August 31, 2028

Arm Intervention/treatment
Active Comparator: Reading Tutoring Intervention
20 hours of one-on-one reading tutoring administered over 6 weeks
Behavioral: Reading Tutoring
20 hours of 1:1 reading tutoring intervention over 6 weeks

No Intervention: Business as Usual
Instruction as usual within schools



Primary Outcome Measures :
  1. Woodcock Johnson Tests of Achievement, Fourth Edition (WJ-IV) [ Time Frame: Baseline, at study entry (Fall of Kindergarten) ]
    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.

  2. Change in Woodcock Johnson Tests of Achievement, Fourth Edition (WJ-IV) [ Time Frame: Baseline, at study entry (Fall of Kindergarten); and approximately 1 year after baseline (Fall of 1st Grade) ]
    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).

  3. Change in Woodcock Johnson Tests of Achievement, Fourth Edition (WJ-IV) [ Time Frame: Approximately 1 year after baseline (Fall of 1st Grade); and approximately 1 year 3 months after baseline (Spring of 1st Grade) ]
    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).



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Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713125


Contacts
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Contact: Julie Delheimer, BS 615-875-5534 educationbrain@vanderbilt.edu
Contact: Lanier P Sachs, M.Ed. 615-936-1167

Locations
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United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37240
Sponsors and Collaborators
Vanderbilt University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Laurie E Cutting, PhD Vanderbilt University

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Responsible Party: Laura Cutting, Principal Investigator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT03713125     History of Changes
Other Study ID Numbers: 181739
1R37HD095519-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dyslexia
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Learning Disorders
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders