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NCT04568824 · ClinicalTrials.gov registry record · NA
Neurocognitive Factors in EdTech Intervention Response
A NA study of Reading Disability, sponsored by University of Connecticut.
- Active
- Registry status
- NA
- Development phase
- 450
- Enrollment target
- 1
- Study location
NCT04568824: Active NA study of Reading Disability, sponsored by University of Connecticut.
NCT04568824 is a NA study of Reading Disability that is active but no longer recruiting, run by University of Connecticut. The registered enrollment target is 450 participants, above the 199-participant average among 4 other Reading Disability trials with a reported enrollment target (126% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04568824, a NA study of Reading Disability, is active but no longer recruiting, sponsored by University of Connecticut.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 450 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The TWRE is a composite of phonemic decoding efficiency (PDE) and sight word efficiency (SWE) -- subtests from the TOWRE II -- these are timed measures of word and nonword reading. The range of scores for the TWRE is 53- 147. Higher scores indicate better performance. Greater change equals better outcome/response.
Conditions Studied
Interventions
- OTHER GraphoLearn reading intervention
- OTHER Vektor math control intervention
Study Locations (1)
New York
- Child Mind Institute - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2020-11-15 |
| Est. Completion | 2026-08-01 |
| Phase | NA |
What the registry record for NCT04568824 still lists
NCT04568824 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 199-participant average among 4 other Reading Disability trials with a reported enrollment target (126% higher).
The record links to 1 condition, with Reading Disability appearing as the primary indexed condition, and to 2 interventions - of which GraphoLearn reading intervention is the first listed.
NCT04568824 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04568824 about?
NCT04568824 is a clinical study titled "Neurocognitive Factors in EdTech Intervention Response". 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 ra...
What is the current status of trial NCT04568824?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 450 participants. The study started on 2020-11-15. Estimated completion is 2026-08-01.
What conditions does trial NCT04568824 study?
This clinical trial studies the following conditions: Reading Disability.
What interventions are being tested in trial NCT04568824?
The interventions under investigation include: GraphoLearn reading intervention (OTHER), Vektor math control intervention (OTHER).
Who is sponsoring clinical trial NCT04568824?
This trial is sponsored by University of Connecticut, which has 107 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04568824 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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