GraphoLearn Reading Intervention for Dyslexia

Overseen By Kayla Sirois

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Connecticut

Disqualifiers: Vision, Hearing, Autism, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 7 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

450 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

How is the GraphoLearn reading intervention treatment different from other treatments for dyslexia?

GraphoLearn is unique because it is a computer-based game that helps children with dyslexia by training them to match speech sounds with written letters, making it both engaging and educational. Unlike traditional methods, it uses technology to provide intensive, personalized practice, and has been adapted for use in various languages and educational contexts worldwide. ^{1 2 3 4 5}

What data supports the effectiveness of the GraphoLearn reading intervention treatment for dyslexia?

Research shows that GraphoLearn, a computer game designed to help with reading, improved reading skills in children at risk for dyslexia by enhancing their ability to read made-up words and quickly name objects. Another study found that a version of GraphoGame helped young children at risk for dyslexia improve their letter knowledge and word decoding skills, giving them a head start in early literacy. ^{1 2 3 6 7}

Research Team

Nicole Landi, PhD

Principal Investigator

University of Connecticut

Eligibility Criteria

This trial is for children aged 6 to 10 who are part of the Healthy Brain Network, have reading difficulties as shown by specific test scores, and can speak English natively. They must be able to use a keyboard or mouse and not have severe vision or hearing issues, certain psychiatric conditions like psychosis or major depression, nor moderate to severe autism.

Inclusion Criteria

I am between 6 and 10 years old.

I am a native English speaker.

You must have a certain level of intelligence, as measured by a specific test, to participate.

Exclusion Criteria

You have trouble seeing or hearing, according to specific tests.

You have thoughts about hurting yourself or others.

I have been diagnosed with major depressive disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week GraphoLearn reading intervention or an active math control

12 weeks

3 to 4 visits (in-person)

Retention

Participants' reading gains are assessed for stability during a retention period

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• GraphoLearn reading intervention
• Vektor math control intervention

Trial Overview The study tests how effective GraphoLearn (a tech-based reading treatment) is compared to a math control intervention in improving reading skills over a period of 12 weeks. It includes follow-up assessments after another 12 weeks without treatment to check if improvements last.

Participant Groups

Group I: GraphoLearn reading intervention Experimental Treatment 1 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.

Group II: Vektor math control Active Control 1 Intervention

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.

GraphoLearn reading intervention is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as GraphoLearn for:

• Reading disability
• Dyslexia

Approved in United States as GraphoLearn for:

• Reading disability
• Dyslexia

Approved in Canada as GraphoLearn for:

• Reading disability
• Dyslexia

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

Haskins Laboratories

Collaborator

Trials

2

Recruited

480+

Child Mind Institute

Collaborator

Trials

4

Recruited

1,400+

Georgia State University

Collaborator

Trials

71

Recruited

33,600+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

The Swiss-German version of GraphoLearn, a computer game aimed at improving reading skills, showed positive effects on pseudoword reading and rapid naming skills in children at risk for dyslexia after 14 weeks of training, with sessions held three times a week.

Children who started training earlier in first grade experienced greater benefits, indicating that early intervention with GraphoLearn can enhance phonological decoding and verbal retrieval skills, making it a valuable tool for supporting reading instruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(Swiss) GraphoLearn: an app-based tool to support beginning readers. Mehringer, H., Fraga-González, G., Pleisch, G., et al.[2021]

The study involved 88 pre-reading kindergarteners at cognitive risk for dyslexia, and those using the adapted GraphoGame-Flemish (GG-FL) showed significant improvements in letter knowledge and word decoding after 12 weeks, indicating its efficacy in enhancing early literacy skills.

While GG-FL effectively improved explicitly trained skills, there were no observed transfer effects to broader phonological and language abilities, suggesting that while it provides a strong foundation, additional interventions may be needed for comprehensive literacy development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Game-Based Phonics Instruction Promotes Print Knowledge in Pre-Readers at Cognitive Risk for Dyslexia. Vanden Bempt, F., Economou, M., Van Herck, S., et al.[2021]

The Jyväskylä Longitudinal Study of Dyslexia has identified effective early predictors of reading difficulties in children, such as newborn brain recordings and letter knowledge, allowing for timely diagnosis and intervention.

GraphoGame™, a computer game designed for reading instruction, has proven to be an effective intervention tool for at-risk children and is being used widely in Finland and beyond to support reading development regardless of the underlying causes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dyslexia-Early Identification and Prevention: Highlights from the Jyväskylä Longitudinal Study of Dyslexia. Lyytinen, H., Erskine, J., Hämäläinen, J., et al.[2020]

In a study involving 24 students with dyslexia, treatment A, which included orthographic spelling strategies and rapid accelerated reading (RAP) training, significantly improved decoding rates compared to treatment B, which focused on phonological awareness.

Both treatment groups showed overall improvements in reading and writing skills, but treatment A's approach, which integrated orthographic strategies, was particularly effective in enhancing spelling and reading fluency, indicating that combining phonics with orthographic strategies can benefit students with dyslexia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching children with dyslexia to spell in a reading-writers' workshop. Berninger, VW., Lee, YL., Abbott, RD., et al.[2013]

Dyslexic children can process written language at the graphophonological level, indicating that they have some ability to connect sounds with letters despite their phonological deficits.

Over a year, dyslexic readers showed performance improvements in graphophonological tasks, with their accuracy and response times becoming comparable to younger normal readers, but still differing from their age-matched peers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Graphophonological processes in dyslexic readers of French: a longitudinal study of the explicitness effect of tasks. Daigle, D., Berthiaume, R., Plisson, A., et al.[2012]

GraphoGame (GG) is an effective technology-based intervention designed to help children with reading difficulties by training them to match speech sounds with their written forms, and it has been successfully implemented in Finland for literacy support.

The program is being adapted for use in African countries, where it aims to improve reading skills among children in regions with transparent writing systems, potentially benefiting millions of children who struggle with literacy despite years of schooling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GraphoGame - a catalyst for multi-level promotion of literacy in diverse contexts. Ojanen, E., Ronimus, M., Ahonen, T., et al.[2020]

The GraphoLearn (GL) technology effectively supports early readers in acquiring basic spelling and reading skills through a digital game-based learning environment, utilizing repetition and reinforcement of connections between spoken and written language.

Originally developed for children at risk of reading disorders in Finland, GL has now been shown to benefit all early readers, regardless of their educational, social, or biological challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting Acquisition of Spelling Skills in Different Orthographies Using an Empirically Validated Digital Learning Environment. Juhani Lyytinen, H., Semrud-Clikeman, M., Li, H., et al.[2021]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

(Swiss) GraphoLearn: an app-based tool to support beginning readers. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Digital Game-Based Phonics Instruction Promotes Print Knowledge in Pre-Readers at Cognitive Risk for Dyslexia. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Dyslexia-Early Identification and Prevention: Highlights from the Jyväskylä Longitudinal Study of Dyslexia. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Teaching children with dyslexia to spell in a reading-writers' workshop. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Graphophonological processes in dyslexic readers of French: a longitudinal study of the explicitness effect of tasks. [2012]

6. Switzerland pubmed.ncbi.nlm.nih.gov

GraphoGame - a catalyst for multi-level promotion of literacy in diverse contexts. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Supporting Acquisition of Spelling Skills in Different Orthographies Using an Empirically Validated Digital Learning Environment. [2021]