Executive Function in Early Childhood
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03713125|
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : December 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Reading Disability||Behavioral: Reading Tutoring||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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.
- 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).
- 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).
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
|Contact: Julie Delheimer, BSfirstname.lastname@example.org|
|Contact: Lanier P Sachs, M.Ed.||615-936-1167|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37240|
|Principal Investigator:||Laurie E Cutting, PhD||Vanderbilt University|