Clinical Trial

Neurocognitive Factors in EdTech Intervention Response

Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2020-09-23; most recent amendment 2025-08-29.
Status change: Recruiting → Active, Not Recruiting 2025-07-21
Status change: Not Yet Recruiting → Recruiting 2021-03-08
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 Reading Disability
Enrollment 450 participants
Start Date 2020-11-15
Primary Completion 2025-08-29 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-02