Reading Disability Clinical Trial
Official title:
Effectiveness and Predictors of Intervention Response for a Technology-based Reading Intervention in the Home
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.
Status | Recruiting |
Enrollment | 450 |
Est. completion date | November 5, 2026 |
Est. primary completion date | November 5, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 10 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Child Mind Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
University of Connecticut | Child Mind Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Georgia State University, Haskins Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Test of Word Reading Efficiency (TOWRE II), total word reading efficiency (TWRE) measure | 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. | Assessment is given before and after the intervention, ~12 weeks apart for the primary outcome; the assessment will also be re-administered after a 12 week retention period | |
Secondary | Woodcock Johnson Tests of Achievement (WJ-IV), Letter Word identification (ID) and Word Attack subtests. | untimed tests of word and nonword reading. The range of raw scores for the WA = 0-32 and the range of raw scores for the ID is 0-78; higher scores indicate better performance. Greater change equals better outcome/response. | Assessment is given before and after the intervention, ~12 weeks apart; the assessment will also be re-administered after a 12 week retention period. | |
Secondary | Phonological Awareness (PA), Phonological Memory, (PM) and Rapid Naming (RN), which are composite scores and will be assessed with the Comprehensive Test of Phonological Processing (CTOPP-II) | These are measures of phonological awareness and processing. For PA, the range of scores is 43 - 165; for the PM, the range of scores is 46-162; for the RN, the range of scores is 46-162. Higher scores indicate better performance. Greater change equals better outcome/response. | Assessment is given before and after the intervention, ~12 weeks apart; the assessment will also be re-administered after a 12 week retention period. | |
Secondary | EEG measures of phonological discrimination and letter sound processing/integration | Neurobiological measures of sensitivity to phonological information and degree of letter sound integration. Score range and better/worse designation are not possible for this outcome measure. | Assessment is given before and after the intervention, ~12 weeks apart. |
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