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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Other trials in Italy

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:

  1. The selective stimulation of a cerebral hemisphere and specific reading strategies.
  2. 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.

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 groups in NCT04384718
Study groupRoleWhat they receive
Medea GroupGroup of children with Developmental Dyslexia treated with Tachidino protocol at IRCCS Medea
Asur GroupGroup of children with Developmental Dyslexia treated with Tachidino protocol at Asur Marche
Waiting list GroupGroup 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted12 May 2020
  2. Study startJun 2020 (estimated)
  3. Primary completionSep 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

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)
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

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.

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