ClinicalTrials.gg
CompletedNCT04568824Updated Oct 20, 2026Results posted

Neurocognitive Factors in EdTech Intervention Response

An interventional study of GraphoLearn reading intervention and Math control intervention in Reading Disability, sponsored by University of Connecticut. Completed at 1 site in United States. Open to participants aged 6 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by University of Connecticut · Not applicable, Interventional, and Treatment

Updated Oct 20, 2026Now CompletedResults posted+5 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
315
Allocation
Randomized
Ages
6 Years to 11 Years
Sex
All
01

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.

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.

02

Conditions studied

  • Reading Disability

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03

In context

Dyslexia

127 studies on the registry are indexed under Dyslexia; 27 are open to participants now.

This study's enrollment of 315 is above the median of 71 across 106 interventional studies indexed under Dyslexia.

Browse Dyslexia studies →

Lead sponsor

University of Connecticut is the lead sponsor of 135 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
315 participants (actual)

Study arms

  • Experimental
    GraphoLearn reading intervention

    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

  • Active comparator
    Math control

    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: Math control intervention

Interventions

  • OtherGraphoLearn reading intervention

    This is an Edtech reading intervention

  • OtherMath control intervention

    This is an Edtech math/cognition intervention

06

What researchers measure

Primary outcomes

  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.

    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.

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

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

07

Results

Posted Oct 20, 2026
Limitations and caveats
1. The sample size is smaller than planned due to COVID-19 related disruptions 2. Attrition was greater than expected due to COVID-19 related disruptions 3. The active (math) control consisted of two different control treatments because the original math game became unavailable following closure of the software company

Participant flow

All participants were recruited from the Healthy Brain Network (HBN), a study of children ages 5-21 with behavioral or learning concerns. Eligible families were approached after completing HBN assessments and introduced to our co-located research coordinator. HBN used a community-referred recruitment model, with outreach through educators, care providers, community organizations, parent email lists, and events. Families received comprehensive diagnostic reports and treatment recommendations.

Participant flow — Overall Study
MilestoneGraphoLearn Reading InterventionMath Control
Started166149
Completed9377
Not completed7372

Outcome measures

PrimaryTest 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.

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.
Reported as:
Mean · units on a scale
Test of Word Reading Efficiency (TOWRE II), Total Word Reading Efficiency (TWRE) Index
units on a scaleGraphoLearn Reading InterventionMath Control
Test of Word Reading Efficiency (TOWRE II), Total Word Reading Efficiency (TWRE) Index83.12 ± 13.8280.28 ± 13.18
Statistical analysis
  • GraphoLearn Reading Intervention vs Math Control · Linear Mixed-Effects Regression · p = 0.728 (p-value for group×time) · Group×time β: -0.018 · 95% CI -0.119 to 0N/A - See CI values above
SecondaryWoodcock 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.

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

Results for this outcome have not been posted.

SecondaryPhonological 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.

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

Results for this outcome have not been posted.

SecondaryEEG 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.

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

Results for this outcome have not been posted.

Adverse events

Collected over From enrollment until the end of follow up, including the optional play period, or study discontinuation, up to 42 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GraphoLearn Reading Intervention0/166 (0%)0/166 (0%)0/166 (0%)
Math Control0/149 (0%)0/149 (0%)0/149 (0%)
GraphoLearn Reading Intervention Post Math Control0/17 (0%)0/17 (0%)0/17 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)GraphoLearn Reading InterventionMath ControlTotal
Mean8.0 ± 1.278.0 ± 1.298.0 ± 1.28
Sex: Female, Male
Sex: Female, Male(Participants)GraphoLearn Reading InterventionMath ControlTotal
Female7967146
Male8782169
Race (NIH/OMB)
Race (NIH/OMB)(Participants)GraphoLearn Reading InterventionMath ControlTotal
American Indian or Alaska Native000
Asian5611
Native Hawaiian or Other Pacific Islander011
Black or African American191938
White9275167
More than one race203050
Unknown or Not Reported301848
Region of Enrollment
Region of Enrollment(Participants)GraphoLearn Reading InterventionMath ControlTotal
United States166149315
TOWRE Total Word Reading Efficiency (TWRE) Index
TOWRE Total Word Reading Efficiency (TWRE) Index(units on a scale)GraphoLearn Reading InterventionMath ControlTotal
Mean77.65 ± 13.6478.74 ± 13.4078.17 ± 13.52
08

Study locations

1 site
  • Child Mind Institute
    New York, New York 10022, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

Supporting information: Analytic code

Time frame: after study completion

Access criteria: undecided

10

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Oct 20, 2026
Results
Results posted
posted Oct 20, 2026
Enrollment
450 (estimated)→315 (actual)
Oct 20, 2026
Eligibility
Maximum age 10 Years→11 Years
Oct 20, 2026
Interventions
Changed Vektor math control intervention→Math control intervention. Arm changed Vektor math control→Math control
Oct 20, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedTest of Word Reading Efficiency (TOWRE II), total word reading efficiencyTotal Word Reading Efficiency (TWRE) measureIndexTime 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 → 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.
Oct 20, 2026
Documents
Secondary outcomes
3 edited
What changed in the outcomes
  • EditedWoodcock Johnson Tests of Achievement (WJ-IV), Letter Word identificationIdentification (ID) and Word Attack subtestsSubtests.Time frame: Assessment is given before and after the intervention, ~12 weeks apart; the assessment will also be re-administered after a 12 week retention period.
  • EditedPhonological Awareness (PA), Phonological Memory, (PM) and Rapid Naming (RN), which are composite scoresWhich Are Composite Scores and willWill be assessed withAssessed With the Comprehensive Test of Phonological Processing (CTOPP-II)Time frame: Assessment is given before and after the intervention, ~12 weeks apart; the assessment will also be re-administered after a 12 week retention period.
  • EditedEEG measuresMeasures of phonological discriminationPhonological Discrimination and letter sound processingLetter Sound Processing/integrationIntegrationTime frame: Assessment is given before and after the intervention, ~12 weeks apart.
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Active, not recruiting→Completed
    Results posted
    Enrollment 450 (estimated)→315 (actual)
    Eligibility Maximum age 10 Years→11 Years
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedTest of Word Reading Efficiency (TOWRE II), total word reading efficiencyTotal Word Reading Efficiency (TWRE) measureIndexTime 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 → 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 edited
    What changed in the outcomes
    • EditedWoodcock Johnson Tests of Achievement (WJ-IV), Letter Word identificationIdentification (ID) and Word Attack subtestsSubtests.Time frame: Assessment is given before and after the intervention, ~12 weeks apart; the assessment will also be re-administered after a 12 week retention period.
    • EditedPhonological Awareness (PA), Phonological Memory, (PM) and Rapid Naming (RN), which are composite scoresWhich Are Composite Scores and willWill be assessed withAssessed With the Comprehensive Test of Phonological Processing (CTOPP-II)Time frame: Assessment is given before and after the intervention, ~12 weeks apart; the assessment will also be re-administered after a 12 week retention period.
    • EditedEEG measuresMeasures of phonological discriminationPhonological Discrimination and letter sound processingLetter Sound Processing/integrationIntegrationTime frame: Assessment is given before and after the intervention, ~12 weeks apart.
    Interventions Changed Vektor math control intervention→Math control intervention. Arm changed Vektor math control→Math control
    + 3 other changes: verification date, date precision and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT04568824
Collaborators
Child Mind Institute, Haskins Laboratories, Georgia State University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Nicole Landi (Professor, University of Connecticut) — Principal investigator
First posted
Sep 29, 2020
Start date
Nov 15, 2020
Primary completion
Aug 29, 2025
Completion
Aug 1, 2026
Results posted
Oct 20, 2026
Last update
Oct 20, 2026

Study contacts

Nicole Landi, PhD
principal investigator · University of Connecticut

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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