Assessing the Generalizability of the Tachidino Protocol to Different Clinical Contexts

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.

Study Overview

• Status: Unknown
• Conditions: Developmental Dyslexia

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.

• Study Type: Observational
• Enrollment (Anticipated): 32

Contacts and Locations

Study Locations

• Italy
  • Pesaro, Italy
    • ASUR Marche, Centre for Clinical Child Neuropsychology
  • Urbino, Italy
    • University of Urbino
  • LC
    • Bosisio Parini, LC, Italy, 23842
      • Scientific Institute IRCCS E. Medea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	4 weeks

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea
• Collaborators: University of Urbino "Carlo Bo"; Asur Marche - AV1 - Centre for Clinical Child Neuropsychology

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (ACTUAL): May 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Intervention; telerehabilitation; Developmental Dyslexia; Hemisphere-specific stimulation; Visual-attentional training
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Dyslexia
• Other Study ID Numbers: 05-20 oss (to be confirmed)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No