Assessing the Generalizability of the Tachidino Protocol for Intervention on Reading and Spelling Disorders to Different Clinical Contexts
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 32
- Locations
- 3
- Primary Endpoint
- change from pre-test to post-test in reading ability
Study Overview
Brief Summary
The study aims to document the effectiveness and acceptability of the intervention system for specific reading and writing disorders, in use at Scientific Institute (IRCCS) Medea, as applied and adapted to a different clinical context and socio-demographic situation. To this purpose, two groups of children will be recruited and treated in two different contexts, and treatment outcomes will be compared. The first one is the centre where the Tachidino platform has been developed and validated, the second one is a different centre, in a different geographical region where lower digital alphabetization may be a disadvantaging factor, but lower population density and the presence of fewer centres for assessment and intervention for learning disorders make remotely monitored protocols even more valuable.
Detailed Description
Specifically, the intervention system based on the web platform "Tachidino" and routinely used for the rehabilitation of reading and spelling disorders at Medea, Lombardy region, would be extended to Marche (precisely, the clinical service connected to Urbino University, located in Pesaro, a coastal town in Central Italy), a different geographical region with different population characteristics. Precisely, the Lombardy region is a highly industrialized region with the highest digitalization rate in Italy, whereas Marche is a more agriculture-oriented region, with lower population density and less widespread use of digital technologies. The main aim of the study is, then, to ascertain whether the effectiveness levels found for the treatment protocol in the original context generalize to a different context and population.
The system for the empowerment of reading and spelling skills ("Tachidino" software) is based on two principles of proven effectiveness:
- The selective stimulation of a cerebral hemisphere and specific reading strategies.
- The training of selective visuospatial attention, as well as the perception of rapid movement and the control of visual crowding effects.
Clinical and assessment procedures
In current clinical practice at IRCCS Medea, 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 7 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A formal diagnosis of Developmental Dyslexia, Specific Reading Disorders, or Mixed Scholastic Learning Disorders
- •Age between 7 and 16
- •Attending at least the third class of primary school
- •Monolingual speakers of Italian or bilingual speakers with perfect mastery of the Italian language (equivalent to monolinguals)
- •Intelligence Quotient (IQ) >= 80
- •At least one z-score below -2 Standard Deviations from age mean in at least one of the following tests: text reading, word reading, nonword reading ("DDE-2" battery, "MT" tests)
- •Not having received any specific rehabilitation treatment for dyslexia before
Exclusion Criteria
- •Intellectual disability
- •Neurological disorders
- •Sensory deficits that are not /cannot be corrected-to-normal by lenses or hearing aids.
Outcomes
Primary Outcomes
change from pre-test to post-test in reading ability
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)
Secondary Outcomes
- change from pre-test to post-test in executive functions(4 weeks)
- change from pre-test to post-test in short-term-memory(4 weeks)
- difference in change between treated and untreated children(4 weeks)
- change from pre-test to post-test in metaphonological ability(4 weeks)