Neurocognitive Factors in EdTech Intervention Response

NCT04568824 | Active Not Recruiting

• 2 other identifiers: H20-0089R01HD101842
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Reading Disability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Woodcock Johnson Tests of Achievement (WJ-IV), Letter Word identification (ID) and Word Attack subtests.

  Assessment is given before and after the intervention, ~12 weeks apart; the assessment will also be re-administered after a 12 week retention period.

• 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)

  Assessment is given before and after the intervention, ~12 weeks apart; the assessment will also be re-administered after a 12 week retention period.

• EEG measures of phonological discrimination and letter sound processing/integration

  Assessment is given before and after the intervention, ~12 weeks apart.

Study Arms (2)

GraphoLearn reading intervention

EXPERIMENTAL

GraphoLearn is a research-based treatment, delivered as an engaging computer game. Players match auditory targets (e.g., phonemes, rimes) to visual targets (single letters, letter sequences, words). The complexity of the items within each level is ordered such that at each level, the most frequent and regular mappings are introduced first based on measures such as orthographic/phonological neighborhood size and morphological family size. GraphoLearn allows the children to practice and reinforce lessons at their own individual trial pace and provides a record of performance progress that can be used to guide analyses.

Other: GraphoLearn reading intervention

Vektor math control

ACTIVE COMPARATOR

We selected an active control to maximize the specificity of the treatment outcomes; to this end, math games are among the most commonly used. Game sessions support learning numerical mathematical skills and cognition related to mathematical skills. In addition to math, this game contains training tasks for visuospatial working memory, spatial visualization and visuospatial reasoning. The overall theme of the game and feedback style are similar to those in GraphoLearn.

Other: Vektor math control intervention

Interventions

GraphoLearn reading intervention OTHER

This is an Edtech reading intervention

GraphoLearn reading intervention

Vektor math control intervention OTHER

This is an Edtech math/cognition intervention

Vektor math control

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University of Connecticut: lead
• Child Mind Institute: collaborator
• Haskins Laboratories: collaborator
• Georgia State University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Child Mind Institute

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Nicole Landi, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The only masking is done at the level of data analysis, as it is readily evident to participants and those monitoring which group the participants are in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a parallel intervention design with crossover elements (control group is offered the intervention after completion of the control intervention). We will evaluate a reading intervention of interest in comparison to a math control.

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 29, 2020
• Study Start: November 15, 2020
• Primary Completion: August 29, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: after study completion
• Access Criteria: undecided

Locations

US (1)