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Neurocognitive Factors in EdTech Intervention Response

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv9
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Nov 5, 2025 to Aug 29, 2025
    • Study completion date: Nov 5, 2026 to Aug 1, 2026
    • Site details revised
    v8
  3. Minor Primary completion date: Oct 2025 to Nov 5, 2025
    • Study completion date: Oct 2026 to Nov 5, 2026
    v7
  4. Minor 3 versions Re-verified since Mar 29, 2021, no change to tracked fieldsv4-v6
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2020 to Nov 15, 2020
    v3
  6. Minor Eligibility criteria shortened, about 61 wordsv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The current project will carry out a large-scale, randomized controlled trial (RCT) to examine the effectiveness of a home-administered technology-based treatment for reading disability (GraphoLearn) in a diagnostically diverse children with reading disability (ages 6.0-10.00). To accomplish this rapidly and with minimal cost, the experimenters will leverage the Healthy Brain Network \[HBN\], an ongoing study of mental health and learning disorders in children ages 5.0-21.0 whose family have one or more concerns about behavior and/or learning (target n = 10,000; current enrollment = 3000+). The HBN includes comprehensive psychiatric, cognitive, electroencephalogram \[EEG\] and multimodal magnetic resonance imaging \[MRI\] characterizations for all participants, providing the present work rich data to build from. The present work will recruit 450 children (ages 6.0-10.0) with reading difficulty from the HBN. In order to evaluate GraphoLearn effectiveness the experimenters will compare reading (and related language skills) before and after a 12-week GraphoLearn reading intervention relative to an active (math) control. The experimenters also assess the stability of the reading gains by including a 12 week retention period ( with pre and post retention assessment). The experimenters hypothesize that they will observe significant gains in reading (and related language) skills relative to the math control conditions, but that these gains will be variable and predicted by participant and environment level factors (predictive models are explored under Aim 2). This evaluation will involve a 3 to 4 visit between groups longitudinal study with cross over elements to evaluate GraphoLearn in struggling readers ages 6-10 using and pre-post behavioral and EEG assessment.
Trial Details
NCT Number NCT04568824
Lead Sponsor University of Connecticut
Collaborators: Child Mind Institute, Haskins Laboratories, Georgia State University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)
Reading Disability
Related terms Dyslexia
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov