Scientific Institute IRCCS E. Medea
Bosisio Parini, LC, 23842, Italy
NCT Number: NCT04382482
The study aims to document the effects of the intervention system for specific reading and spelling disorders, currently in use at Scientific Institute (IRCCS) Medea as an innovative intervention model in e-health mode. The model constitutes the application of research data collected in more than fifteen years research on the causes of dyslexia and rehabilitation techniques, combined with the most advanced technologies for remotely-controlled clinical management and therapy monitoring through adaptive, self-updating algorithms.
A single group of about 80 children will be observed and their performance on reading, spelling and metaphonological tests at pre-test, post-test and follow-up (after 6 months) will be recorded in order to assess improvement (and, consequently, treatment effectiveness) and its stability. The improvements obtained in four weeks treatment will subsequently be compared with those obtained with outpatient intervention programmes of the same duration and intensity.
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Notify Me7 year–16 year
All sexes
Observational
Bosisio Parini, LC, 23842, Italy
The system for the improvement of reading and writing skills ("Tachidino" software) is based on two principles of proven effectiveness:
Studies carried out by researchers at IRCCS Medea have shown excellent results for the two types of treatment (Hemisphere-specific stimulation according to the Balance Model, and Visual-attentional training with Action Video- Games or Wii games, but above all they showed how these effects are strongly enhanced by the association in a single intervention.
Clinical and assessment procedures
In the Tachidino program, the child (sitting in fron of the computer screen) is required to recognize the target candy (a spiral candy) among various candies (distractors) and press the space bar at the exact moment the target candy is crossing a circle target (fixation point). The word to be decoded/encoded is presented, visually or auditory, only if the child clicks at the right moment, thus ensuring that fixation was in correspondence with the fixation point in the center of the visual field. If the bar is pressed in the target timeframe and in correspondence of the target candy, the word to be decoded/encoded is immediately presented and the child is asked to either write the word on the keyboard or re-order a sequence containing all the correct graphemes in random order.
All visual stimuli are presented at tachistoscopic speed to a visual hemifield in order to stimulate the contralateral hemisphere to a greater degree, or they may also be flashed in the center of the computer screen, involving both hemispheres simultaneously.
The visual hemisphere-specific stimulation is based on a revisit of Bakker's 'Balance model'. Each child was classified as a P-, L-, or M-type dyslexic reader based on the persistent over-reliance on specific reading strategies as shown by reading and spelling errors, and on reading speed.
As per current clinical practice, intervention in "e-health" mode is divided into one or more rehabilitation modules through the use of the Tachidino platform, with systematic monitoring and motivational reinforcement by professionals with experience in e-health approaches. In order to be included in the training, the child must have already obtained a diagnosis of dyslexia, according to the current diagnostic standards.
The structure of the intervention modules, as currently implemented, is as follows:
Participants' characteristics: Children aged between 7 and 14 years with a diagnosis of Specific Reading Disorder or Specific Spelling Disorder, not treated before.
The improvements obtained in one month treatment will be compared with those obtained with outpatient intervention programmes of the same duration and intensity, combining treatment based on the two component parts: Visual Hemisphere-Specific Stimulation (V-HSS) and Visual-Attentional Training with Action Video Games.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Web-platform delivering remote treatment of reading and spelling disorders through the (visual or auditory) presentation of words and sentences to be either decoded or corrected (reordering wrong letter sequences).
Time frame: 4 weeks
Difference in treatment-related changes (post-test minus pre-test) observed in reading measures (speed and accuracy in word, nonword and text reading standardized tests: Memory Training (MT) group reading test and "Developmental Dyslexia and Dysgraphia (DDE-2); average of the scores expressed as z-scores with respect to age norms)
Time frame: 4 weeks
Difference in treatment-related changes (post-test minus pre-test) observed in spelling tests (writing to dictation of words, nonwords and sentences) - average of the scores expressed as z-scores with respect to age norms in standardized tests ("DDE-2", "Diagnosis of Dysgraphic Disorders" (DDO-2))
Time frame: 4 weeks
Difference in treatment-related changes (post-test minus pre-test) observed in metaphonological tests (phonemic elision and phoneme blending) - average of the number of errors in the two tests
Time frame: 7 months (1 month intervention and 6 months follow-up)
no significant difference between post-test scores and follow-up scores (follow-up 6 months after discharge and in the absence of further intervention) in text, word and nonword reading ("MT" tests, "DDE-2")
Time frame: 4 weeks
scores expressed by parents and patients at post-test, on a questionnaire concerning satisfaction with the delivery of remote intervention and its effects
Time frame: 4 weeks
difference in z-scores (reading speed and accuracy measured with "MT tests" and "DDE-2") between changes obtained with Tachidino remotely delivered intervention and inpatient treatment with the same combined components (Visual Hemisphere-Specific Stimulation and Action Video-Games), both conducted over 4 weeks. Data about improvement obtained with inpatient treatment were previously collected at IRCCS E. Medea (ClinicalTrials.gov NCT02791841, published in Frontiers in Psychology, 2020)
IRCCS Eugenio Medea
Other
Remotely Controlled Intervention for Developmental Reading and Spelling Disorders
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