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GraphoLearn Reading Intervention for Dyslexia
N/A
Recruiting
Led By Nicole Landi, PhD
Research Sponsored by University of Connecticut
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be 6.0 to 10.0 years old
Must be a native speaker of English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessment is given before and after the intervention, ~12 weeks apart; the assessment will also be re-administered after a 12 week retention period.
Awards & highlights
Study Summary
This trial will examine the effectiveness of a home-administered technology-based treatment for reading disability in children ages 6.0-10.0. The experimenters will recruit 450 children with reading difficulty from the Healthy Brain Network and compare reading skills before and after a 12-week GraphoLearn reading intervention relative to an active (math) control.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves educational technology interventions rather than medical treatments, traditional side effects are not applicable. However, participants may experience fatigue or frustration during the learning process.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 6 and 10 years old.
Select...
I am a native English speaker.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessment is given before and after the intervention, ~12 weeks apart; the assessment will also be re-administered after a 12 week retention period.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessment is given before and after the intervention, ~12 weeks apart; the assessment will also be re-administered after a 12 week retention period.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Test of Word Reading Efficiency (TOWRE II), total word reading efficiency (TWRE) measure
Secondary outcome measures
Articulation Disorders
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)
Woodcock Johnson Tests of Achievement (WJ-IV), Letter Word identification (ID) and Word Attack subtests.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: GraphoLearn reading interventionExperimental Treatment1 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 controlActive Control1 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.
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Who is running the clinical trial?
Haskins LaboratoriesUNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled
Child Mind InstituteOTHER
2 Previous Clinical Trials
724 Total Patients Enrolled
University of ConnecticutLead Sponsor
184 Previous Clinical Trials
157,843 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 6 and 10 years old.You have trouble seeing or hearing, according to specific tests.You have thoughts about hurting yourself or others.I am a native English speaker.You must have a certain level of intelligence, as measured by a specific test, to participate.I have been diagnosed with major depressive disorder.I have difficulty using a keyboard, mouse, or touchscreen due to a neurological condition.You have a severe mental illness that causes you to lose touch with reality.You need to have a score lower than 85 on a reading test called TOWRE.You have experienced a period of extreme excitement or agitation.You have moderate to severe autism.
Research Study Groups:
This trial has the following groups:- Group 1: GraphoLearn reading intervention
- Group 2: Vektor math control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Dyslexia Patient Testimony for trial: Trial Name: NCT04568824 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent has enrollment in this experiment progressed?
"Yes, the information available on clinicaltrials.gov demonstrates that this trial is still accepting participants. It was originally posted in November of 2020 and updated as recently as June 14th 2022; a total of 450 patients are needed at one medical centre for the study to advance."
Answered by AI
Is the participant pool of this medical trial restricted to those below a certain age?
"To be eligible for this study, participants must range from 6 to 10 years old. Additionally, there are 13 studies available for those under 18 and 1 specifically designed for individuals over 65."
Answered by AI
Could I potentially be a suitable participant for this research program?
"This clinical study is seeking a cohort of 450 children aged between 6 and 10 with reading impairment. Eligibility requirements include being enrolled in the Healthy Brain Network, having a TWRE composite score below 85, and an FSIQ greater than 75 on the WISC-V scale."
Answered by AI
Is enrollment still available for this experiment?
"Clinicialtrials.gov depicts that this investigation is actively looking for recruits. It was originated on November 15th 2020 and the latest update occurred June 14th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
What site did they apply to?
Child Mind Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Need reading support for son, we like to do trials to help with research. I would like to evaluate him if he has dyslexia because he is very behind in reading and has signs of dyslexia and IEP for learning disability.
PatientReceived no prior treatments
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