Neurocognitive Factors in EdTech Intervention Response
Running, not enrolling · Not applicable
Conditions studied: Reading Disability
In brief
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.
Key facts
- Study ID
- NCT04568824
- Run by
- University of Connecticut
- People needed
- 450
- Starts
- 2020-11-15
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2025-09-02
Who can join
Age: 6 and older, up to 10. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Must be 6.0 to 10.0 years old
- Must be currently enrolled in Healthy Brain Network (HBN)
- Must have a standard score <85, on the Test of Word Reading Efficiency (TOWRE), Total Word Reading Efficiency (TWRE) composite
- Must have full Scale IQ (FSIQ) on the Wechsler Intelligence Scale for Children (WISC V) > 75
- Must be a native speaker of English
You may not qualify if…
- Vision or hearing impairment, per the Snellen Test and audiometer measurement
- Moderate to severe autism (levels 2-3)
- Major depressive disorder
- Suicidal or homicidal ideation
- Psychotic disorder
- Manic episode
- Any neurologic impairment that limits the ability to use a keyboard or mouse, or to touch a screen
Where it is running
- Child Mind Institute — New York, New York, United States
Full record on ClinicalTrials.gov
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