AzTrials
AzTrials

Reading DisabilityNCT04568824

Neurocognitive Factors in EdTech Intervention Response

A study testing GraphoLearn reading intervention in people with Reading Disability, run by University of Connecticut at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 6 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Reading Disability
What is being tested?
GraphoLearn reading intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
315 participants
Where
1 siteUnited States
Study dates
15 Nov 2020to 1 Aug 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Child Mind Institute

    New York, New York, 10022

Other trials in United States

About this study

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).

Read more

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.

Read the detailed description

The overarching goal of this proposal is to address limitations inherent in current remedial approaches utilized in reading disability (RD). Specifically, the experimenters aim to evaluate the effectiveness of a technology-based intervention for children with RD, using a randomized controlled trial. Nature of the Problem. Reading Disability (RD) is the most common learning disability, affecting 10 - 15% of school age children. It incurs major functional impairments at all stages of life. A wealth of data documents lifelong disadvantages in educational and occupational attainment. Problematically, current evidence-based reading interventions largely rely on services by trained specialists, either in well-resourced classrooms or clinical settings. As such, under-resourced schools (or countries) often are unable to provide reading interventions for their students. This potentially tragic situation has fostered the proposed project that aims to evaluate an affordable, promising, technology-based, treatment, which has twofold advantages, that of being home-based and, also, to be implemented without direct expert supervision, thereby minimizing resource demands. Recent studies have supported the efficacy of technology-based reading interventions, particularly GraphoLearn, which focuses on teaching phonological skills and letter sound correspondence, though with notable variation in effect sizes. As highlighted in a recent meta-analysis, sample sizes tend to be small, and there is marked variation in key methodological components across studies, particularly gameplay dosage (which is well below expert recommendations in most studies), control group (e.g., active versus passive), and level of adult involvement in administration. Most relevant, the utility of GraphoLearn has not been adequately examined outside the confines of controlled school-settings, thus failing to inform on the value of home administration - the major positive feature of the GraphoLearn. Similarly, possible predictors of negative outcomes for home administration are unexplored (e.g., compliance with prescribed gameplay dosage, which, as noted in our preliminary data, can vary).

Overview for Aim 1. The proposed project addresses limitations inherent in remedial interventions by implementing a large-scale, randomized controlled trial (RCT) of home-administered GraphoLearn in 450 RD children (boys and girls, ages 6.0-10.0). To accomplish this goal rapidly and with minimal cost, the experimenters will recruit participants enrolled in the Healthy Brain Network [HBN], an ongoing study of mental health and learning disorders in children, ages 5.0-21.0, whose family have concerns about behavior and/or learning (target n = 10,000; current n = 3000+). The HBN includes comprehensive psychiatric, cognitive, EEG and multimodal MRI characterizations for all participants, providing the proposed study with rich descriptive data. Reading disabilities will be identified using the TOWRE (standard score < 85). Children will be assigned to a 12-week/20-hour program of GraphoLearn or an "active" control condition, group matched for IQ and reading-level. The control will consist of a math game, similar in style to GraphoLearn, to control for non-specific effects of the intervention, such as time spent on the program, attention, and other factors. Children randomized to the control group will be offered GraphoLearn following the study due to ethical considerations. Consistent with real-world conditions, non-study related interventions during the course of the study period will be permitted. They will be documented for comprehensive sample description, and for analyzing predictors of response (Aim 2).

Aim 1: Evaluate the effectiveness of GraphoLearn in a large sample of children with RD. Children's reading level will be assessed before, during (week 6), and at the end of, the active study (week 12). Extended effects will be evaluated 12 weeks post treatment (week 24). The experimenters hypothesize statistically significant differences in reading level in favor of the GraphoLearn group over the control group at weeks 12 and 24. Should the hypothesis be supported, it will have important public health implications for children with RD (there is no claim that the program will be substitute for individualized, and expert-supervised, reading remediation).

Overview for Aim 2. The identification of participant-level and environment-level factors that predict treatment response is an important topical goal but has not been considered for GraphoLearn. For specialist-based interventions, a consistent finding is that older children, and children with language or cognitive impairments, are less likely to benefit. Here, the experimenters leverage the diversity of co-morbid clinical presentations among poor readers in HBN to identify putative predictors of treatment response. In line with recent studies suggesting the added value of brain-based features for prediction of intervention outcomes, the experimenters also leverage the availability of anatomical MRI data in the development of predictive models.

Aim 2. Identify participant-related and environment-level factors that are significantly associated with GraphoLearn outcomes. The extensive phenotypic and imaging characterizations included in the HBN sample are uniquely suited for exploring an extensive set of participant and environmental factors that may predict treatment outcomes. Random Forest Regression models will be used to predict differences in intervention response to GraphoLearn, based on an a priori set of baseline demographic, cognitive, emotional, brain and home environment variables. Assuming that compliance (i.e., actual time spent playing GraphoLearn relative to prescribed) is found to be a strong predictor of response, exploratory analyses will also look at predictors of compliance to further increase real world value of the proposed work.

Being tested
GraphoLearn reading intervention, Math control intervention
Medical subject headings
Dyslexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GraphoLearn reading interventionOther

    This is an Edtech reading intervention

  • Math control interventionOther

    This is an Edtech math/cognition intervention

Study groups in NCT04568824
Study groupRoleWhat they receive
GraphoLearn reading interventionExperimentalGraphoLearn 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.
Receives: Other: GraphoLearn reading intervention
Math controlActive comparatorWe 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.
Receives: Other: Math control intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Test of Word Reading Efficiency (TOWRE II), Total Word Reading Efficiency (TWRE) Index

    The Total Word Reading Efficiency (TWRE) index 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.

    Measured: 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. T2 (after the intervention) is the primary outcome measure.

Secondary outcomes (3)
  1. 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.

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

  2. 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.

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

  3. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2020
  2. Study start15 Nov 2020
  3. Primary completion29 Aug 2025
  4. Study completion1 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04568824
Sponsor's protocol ID
H20-0089
Other IDs
R01HD101842
Status last verified
Sep 2026
First submitted
23 Sep 2020
Last updated
20 Oct 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Consistent with the policies established by one of the principal investigators (PIs), PI Milham and colleagues on the International Neuroimaging Data-sharing Initiative (INDI), all data will be anonymized prior to being placed in the data repository. All phenotypic data collected during the proposed work, including daily GraphoLearn longitudinal training data, will be shared following completion of data collection, which is anticipated to occur prior to the end of year 4. Electroencephalogram (EEG) data obtained through the proposed work will be shared through INDI as well.

Questions about this trial

What is this clinical trial studying?

A study testing GraphoLearn reading intervention in people with Reading Disability, run by University of Connecticut at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test of Word Reading Efficiency (TOWRE II), Total Word Reading Efficiency (TWRE) Index (time frame: 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. T2 (after the intervention) is the primary outcome measure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in