Executive Function in Early Childhood

• ClinicalTrials.gov Identifier: NCT03713125
• Recruitment Status: Recruiting
• First Posted: October 19, 2018
• Last Update Posted: December 10, 2019
• Sponsor: Vanderbilt University
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Laura Cutting, Vanderbilt University

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.

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.

Study Design

• 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
• Actual Study Start Date: August 13, 2019
• Estimated Primary Completion Date: August 31, 2028
• Estimated Study Completion Date: August 31, 2028

Arms and Interventions

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

Outcome Measures

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).

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: Julie Delheimer, BS; 615-875-5534; educationbrain@vanderbilt.edu

Contact: Lanier P Sachs, M.Ed.; 615-936-1167

Locations

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

• Principal Investigator: Laurie E Cutting, PhD; Vanderbilt University

More Information

• Responsible Party: Laura Cutting, Principal Investigator, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT03713125
• Other Study ID Numbers: 181739; 1R37HD095519-01A1 ( U.S. NIH Grant/Contract )
• First Posted: October 19, 2018
• Last Update Posted: December 10, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Dyslexia; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Learning Disorders; Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders