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Active, not recruiting Not applicable

Literacy Skills Improvement and Early Diagnosis of Specific Learning Disorders (SLD) Using a New Phono Syllabic Program

NCT07510126 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-09-05
Last updated
2026-04-03

Condition(s) studied

Acquisition of Literacy Skills for All Children, Including Those With SLDs, Appropriateness of Referrals for SLD Assessment for Accurate Early Detection of SLDs

Investigational drug(s) / intervention(s)

Alfabeto programOther literacy teaching methods

Alfabeto program: Alfabeto is a structured phono-syllabic program developed by the SApIE Association from Dr. Ventriglia's materials. The method focuses on phono-syllabic and meta-phonological skills, with open CV syllables at the core. The method is generative: once CV decoding is mastered, reading extends to more complex forms. It is structured and explicit, progressing according to increasing phonological difficulty and preventing exposure to whole words before analytic decoding skills are acquired. The program includes five units with 2-hour sessions, clear objectives, exercises and games, and follows cognitive load theory by avoiding distracting stimuli. It adopts a playful approach, encouraging enjoyment of sound pronunciation and treating errors as part of learning.

Other literacy teaching methods: The other literacy teaching methods will be those used in Italian schools to teach reading and writing in first grade (synthetic: alphabetic method, focused on the single sound; phono-syllabic, starting from the single sounds to arrive to syllables; analytical: starting from the whole word; analytical-synthetic: starting from the whole word and then moving to the single letter or vice versa). In second-grade, they will follow the standard program chosen by the teacher.

Study summary

Scientific evidence shows that systematic phonological approaches are more effective than other methods in teaching children to read and should therefore be adopted in schools. Neuropsychological and neuroscientific research confirms that reading acquisition requires activation of the phonological route because engages appropriate neural circuits. Conversely, an early focus on whole word recognition hinders acquisition of the alphabetic code activating inefficient brain pathways. The aim of the randomized controlled trial is to demonstrate that the ALFABETO program, rigorous and structured phono-syllabic approach, is superior to other literacy instruction methods in promoting reading and writing skills in all children, including those with difficulties or at risk of Specific Learning Disorders (SLD). The study will recruit first-grade classes from Comprehensive Institutes in the Friuli Venezia Giulia Region that volunteer to participate to the project. Classes will be randomly assigned to an Experimental Group (ALFABETO program) or a Control Group (literacy method chosen by the class teacher). At least 902 children will be enrolled. The intervention will start in first grade and continue throughout second grade, with classes following the assigned method for both school years. Teachers in the Experimental Group will receive online training session and supervision throughout both school years. They will be provided with ALFABETO teacher manuals and student books for first and second grade. Assessments will be conducted at three time points: T0 (September 2025, prerequisite skills), T1 (May 2026, end of first grade), and T2 (May 2027, end of second grade). Standardized measures will assess reading speed, lexical decision, spelling, phonological processing, and writing speed (second grade only). Questionnaires will also be administered to schools, teachers and families. Children identified as at risk of SLD at T2 will be referred for free diagnostic evaluation at IRCCS Burlo Garofolo. Confirmed diagnoses will follow standard care pathways within the National Health Service. Inclusion criteria include parental informed consent; exclusion criteria include children receiving individualized instruction with a dedicated support teacher (Law 104). Schools must provide instruction in Italian and include first-grade classes with different teachers. Montessori, Waldorf, adult education, and multi-grade classes are excluded.

Eligibility

Sex
ALL
Min age
5 Years
Max age
6 Years
Healthy volunteers
No
Children who will attend, starting in September 2025, first-grade classes of schools in the FVG region: * who have accepted the participation in the project * with Italian as the primary language * with at least two first-grade (non-multigrade) classes in which Italian is taught as the primary language by different teachers, following curricula that do not include Montessori, Waldorf, Pizzigoni, or Agazzi. Inclusion Criteria: Written Informed consent for screening tests signed by parents Exclusion Criteria: Children who need differentiated teaching programming with a dedicated teacher (L.104 Comma 1 e 3)

Primary outcome measure(s)

  • Difference in mean DLC score between EG and GC groups — 8 months from enrolment
    DLC is made up of a list of 60 words and 60 non-words (i.e. nonsense). The task required is to recognize and mark the non-words. The evaluation of the performance is given by the score obtained by adding 1 point for each recognized non-word and subtracting 1 point for each word (i.e. with a complete meaning) marked incorrectly. Outcome variable is continuous and can get to a maximum of 60 points.

Trial sites (1)

FacilityCityRegionStatus
Clinical Epidemilogy and Public Health Research Unit, Institute for Maternal and Child Health IRCCS Burlo Garofolo Trieste Trieste
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07510126 on ClinicalTrials.gov ↗ ← All trials in Italy