search
Back to results

Executive Function in Early Childhood

Primary Purpose

Reading Disability

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reading Tutoring
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Reading Disability

Eligibility Criteria

4 Years - 9 Years (Child)All SexesAccepts 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.

Sites / Locations

  • Vanderbilt UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Reading Tutoring Intervention

Business as Usual

Arm Description

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

Instruction as usual within schools

Outcomes

Primary Outcome Measures

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.
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).
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).

Secondary Outcome Measures

Full Information

First Posted
October 16, 2018
Last Updated
July 20, 2023
Sponsor
Vanderbilt University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT03713125
Brief Title
Executive Function in Early Childhood
Official Title
Early Academic Achievement and Intervention Response: Role of Executive Function
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 13, 2019 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reading Disability

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reading Tutoring Intervention
Arm Type
Active Comparator
Arm Description
20 hours of one-on-one reading tutoring administered over 6 weeks
Arm Title
Business as Usual
Arm Type
No Intervention
Arm Description
Instruction as usual within schools
Intervention Type
Behavioral
Intervention Name(s)
Reading Tutoring
Intervention Description
20 hours of 1:1 reading tutoring intervention over 6 weeks
Primary Outcome Measure Information:
Title
Woodcock Johnson Tests of Achievement, Fourth Edition (WJ-IV)
Description
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)
Title
Change in Woodcock Johnson Tests of Achievement, Fourth Edition (WJ-IV)
Description
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)
Title
Change in Woodcock Johnson Tests of Achievement, Fourth Edition (WJ-IV)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children in Kindergarten (approximate ages 4-9 years) Native English speakers Exclusion Criteria: Children not in Kindergarten at time of enrollment; previous diagnosis of Intellectual Disability; known uncorrectable visual impairment; documented hearing impairment greater than or equal to a 25 decibel (dB) loss; medical contraindication to MRI procedures (e.g., metal devices) - excludes from MRI procedures only; known intelligence quotient (IQ) below 70; a pervasive developmental disorder; and any known neurologic pathology, including epilepsy, spina bifida, cerebral palsy, traumatic brain injury, and brain tumors. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Delheimer, BS
Phone
615-875-5534
Email
educationbrain@vanderbilt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lanier P Sachs, M.Ed.
Phone
615-936-1167
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie E Cutting, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37240
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Executive Function in Early Childhood

We'll reach out to this number within 24 hrs