Assessing the Generalizability of the Tachidino Protocol to Different Clinical Contexts

NCT04384718 | Unknown

• 1 other identifier: 05-20 oss (to be confirmed)
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Developmental Dyslexia

Keywords

Developmental Dyslexia; Intervention; Hemisphere-specific stimulation; Visual-attentional training; telerehabilitation

Outcome Measures

Primary Outcomes (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)

  4 weeks

Secondary Outcomes (4)

• change from pre-test to post-test in metaphonological ability

  4 weeks

• change from pre-test to post-test in short-term-memory

  4 weeks

• change from pre-test to post-test in executive functions

  4 weeks

• difference in change between treated and untreated children

  4 weeks

Study Arms (3)

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

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Intellectual disability
• Neurological disorders
• Sensory deficits that are not /cannot be corrected-to-normal by lenses or hearing aids.

Sponsors & Collaborators

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

Study Sites (3)

Scientific Institute IRCCS E. Medea

Bosisio Parini, LC, 23842, Italy

Location

ASUR Marche, Centre for Clinical Child Neuropsychology

Pesaro, Italy

Location

University of Urbino

Urbino, Italy

Location

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Maria L Lorusso, Ph.D.

  IRCCS E. Medea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria L Lorusso, Ph.D.

CONTACT

031877592; marialuisa.lorusso@lanostrafamiglia.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 12, 2020
• Study Start: June 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

IT (3)