Developmental DyslexiaNCT04384718
Assessing the Generalizability of the Tachidino Protocol to Different Clinical Contexts
An observational study of Developmental Dyslexia, run by IRCCS Eugenio Medea at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Developmental Dyslexia
- How many people
- 32 participants
- Where
- 3 sitesItaly
- Study dates
- Jun 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children will be recruited among those referred to either IRCCS Medea or ASUR Marche because of learning and school-achievement problems. All children who were offered treatment through the web-based platform "Tachidino" and who meet inclusion/ exclusion criteria will be enrolled in the study after their parents have accepted and signed informed consent. After completion of the two treatment groups (32 children), the next 16 children referred to either Centre will be enrolled as Waiting list group and treated after a 4 weeks observation period without treatment.
Who may be able to join
- 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
Who cannot join
- Intellectual disability
- Neurological disorders
- Sensory deficits that are not /cannot be corrected-to-normal by lenses or hearing aids.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Scientific Institute IRCCS E. Medea
Bosisio Parini, LC, 23842
ASUR Marche, Centre for Clinical Child Neuropsychology
Pesaro
Manuela Berlingeri, Ph.D.
University of Urbino
Urbino
Manuela Berlingeri, Ph.D.
About this study
Official title: Assessing the Generalizability of the Tachidino Protocol for Intervention on Reading and Spelling Disorders to Different Clinical Contexts
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.
Read the 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.
The structure of the intervention modules is as follows:
- 1 initial meeting to get to know the child, pre-test assessment - reading and writing tests of words, non-words and sentences, metaphonological tests and text reading tests (reading accuracy and speed) in order to define dyslexia subtypes; intervention planning - demonstration of Tachidino use and programming of first activities
- telephone support to monitor and motivate correct use of the software, during active intervention
- 1 final assessment meeting (with repetition of the tests used at pre-test and compilation of questionnaires).
In addition to the main goal and the above-described procedure, the study will investigate the effects of treatment with additional tests providing parallel versions and lists of stimuli, so as to exclude any possible repetition effect and thus to better highlight "pure" intervention effects.
Participants' characteristics: Children aged between 7 and 16 years with a diagnosis of Specific Reading Disorder, Mixed Disorder of Scholastic Skills or Developmental Dyslexia, pertaining to International Classification of Diseases (ICD-10) codes F81, F81.0, F81.3, referred to one of the two participating centres because of school learning problems.
Total number of subjects: 32 (16 per centre). An additional group of 16 children with Dyslexia and/or Dysgraphia on a waiting list will also be tested and retested after 4 weeks, providing a further control for the effects of intervention.
The number of participants has been determined with a power analysis based on data on the effects of treatment observed in the group already treated with Tachidino at IRCCS Medea. The number of 32 participants turned out to be sufficient to provide a power of 0.8 with alpha set at .005.
- Conditions
- Developmental Dyslexia
- Keywords
- Developmental Dyslexia, Intervention, Hemisphere-specific stimulation, Visual-attentional training, telerehabilitation
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Medea Group | Group of children with Developmental Dyslexia treated with Tachidino protocol at IRCCS Medea | |
| Asur Group | Group of children with Developmental Dyslexia treated with Tachidino protocol at Asur Marche | |
| Waiting list Group | Group of children with Developmental Dyslexia on a waiting list for treatment with Tachidino protocol at IRCCS Medea or Asur Marche |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from pre-test to post-test in reading ability
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)
Measured: 4 weeks
Secondary outcomes (4)
change from pre-test to post-test in metaphonological ability
Difference in treatment-related changes (post-test minus pre-test) observed in metaphonological tests (phonemic analysis and phoneme blending) - average of the number of errors in the two tests
Measured: 4 weeks
change from pre-test to post-test in short-term-memory
Difference in treatment-related changes (post-test minus pre-test) observed in memory tests (direct and indirect span) - average of the number of correct responses in the two tests
Measured: 4 weeks
change from pre-test to post-test in executive functions
Difference in treatment-related changes (post-test minus pre-test) observed in executive functions tests (go-no-go paradigm) - average of the number of correct responses in the two tests
Measured: 4 weeks
difference in change between treated and untreated children
Difference found in pre-post test changes (post-test minus pre-test) observed in reading tests (reading speed and accuracy measured with "MT tests" and "DDE-2") - expressed as z-scores according to age, between the two groups treated with Tachidino remotely delivered intervention and the waiting list group
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study startJun 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DyslexiaStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- University of Urbino "Carlo Bo", Asur Marche - AV1 - Centre for Clinical Child Neuropsychology
- Responsible party
- Sponsor
- Investigators
- Maria L Lorusso, Ph.D., Principal investigator, IRCCS E. Medea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384718
- Sponsor's protocol ID
- 05-20 oss (to be confirmed)
- Status last verified
- May 2020
- First submitted
- 8 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Generalizability of the Tachidino Protocol for Intervention on Reading and Spelling Disorders to Different Clinical Contexts
- ClinicalTrials.gov ID
- NCT04384718
- Acronym / sponsor ID
- 05-20 oss (to be confirmed)
- Conditions
- Developmental Dyslexia
- Keywords
- Developmental Dyslexia, Intervention, Hemisphere-specific stimulation, Visual-attentional training, telerehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- University of Urbino "Carlo Bo", Asur Marche - AV1 - Centre for Clinical Child Neuropsychology
- Study start
- Jun 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The structure of the intervention modules is as follows:
- 1 initial meeting to get to know the child, pre-test assessment - reading and writing tests of words, non-words and sentences, metaphonological tests and text reading tests (reading accuracy and speed) in order to define dyslexia subtypes; intervention planning - demonstration of Tachidino use and programming of first activities
- telephone support to monitor and motivate correct use of the software, during active intervention
- 1 final assessment meeting (with repetition of the tests used at pre-test and compilation of questionnaires).
In addition to the main goal and the above-described procedure, the study will investigate the effects of treatment with additional tests providing parallel versions and lists of stimuli, so as to exclude any possible repetition effect and thus to better highlight "pure" intervention effects.
Participants' characteristics: Children aged between 7 and 16 years with a diagnosis of Specific Reading Disorder, Mixed Disorder of Scholastic Skills or Developmental Dyslexia, pertaining to International Classification of Diseases (ICD-10) codes F81, F81.0, F81.3, referred to one of the two participating centres because of school learning problems.
Total number of subjects: 32 (16 per centre). An additional group of 16 children with Dyslexia and/or Dysgraphia on a waiting list will also be tested and retested after 4 weeks, providing a further control for the effects of intervention.
The number of participants has been determined with a power analysis based on data on the effects of treatment observed in the group already treated with Tachidino at IRCCS Medea. The number of 32 participants turned out to be sufficient to provide a power of 0.8 with alpha set at .005.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medea Group | – | –Group of children with Developmental Dyslexia treated with Tachidino protocol at IRCCS Medea |
| Asur Group | – | –Group of children with Developmental Dyslexia treated with Tachidino protocol at Asur Marche |
| Waiting list Group | – | –Group of children with Developmental Dyslexia on a waiting list for treatment with Tachidino protocol at IRCCS Medea or Asur Marche |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children will be recruited among those referred to either IRCCS Medea or ASUR Marche because of learning and school-achievement problems. All children who were offered treatment through the web-based platform "Tachidino" and who meet inclusion/ exclusion criteria will be enrolled in the study after their parents have accepted and signed informed consent. After completion of the two treatment groups (32 children), the next 16 children referred to either Centre will be enrolled as Waiting list group and treated after a 4 weeks observation period without treatment.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Intellectual disability
- Neurological disorders
- Sensory deficits that are not /cannot be corrected-to-normal by lenses or hearing aids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
4 secondary outcomes
change from pre-test to post-test in metaphonological ability
Time frame: 4 weeks
change from pre-test to post-test in short-term-memory
Time frame: 4 weeks
change from pre-test to post-test in executive functions
Time frame: 4 weeks
difference in change between treated and untreated children
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria L Lorusso, Ph.D. principal investigator
IRCCS E. Medea
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Dyslexia, run by IRCCS Eugenio Medea at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria L Lorusso, Ph.D. (031877592 ext. 0039, marialuisa.lorusso@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from pre-test to post-test in reading ability (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.