Are you healthy and looking to help advance medical science?

You may be eligible to participate in a reading disability clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a reading disability clinical study, and could be compensated for your time.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Reading Disability Clinical Trial in Nashville TN

NCT03713125 | Interventional

Are you healthy and looking to help advance medical science?

You may be eligible to participate in a reading disability clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a reading disability clinical study, and could be compensated for your time.

Recruiting

Male & Female

4 - 9

Years old

This study is looking to recruit 260 Participants

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.

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Details for the study

Brief Title

Executive Function in Early Childhood

Official Title

Early Academic Achievement and Intervention Response: Role of Executive Function

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.

Treatments and/or Procedures

Reading tutoring

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

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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.

Baseline, at study entry (Fall of Kindergarten)

Primary

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).

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

Primary

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).

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

Study 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.