Clinical Epidemilogy and Public Health Research Unit, Institute for Maternal and Child Health IRCCS Burlo Garofolo
Trieste, 34137, Italy
NCT Number: NCT07510126
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.
This study is active but is not currently recruiting participants.
Notify Me5 year–6 year
All sexes
Interventional
Not applicable
Trieste, 34137, Italy
Specific learning disorders (SLDs) are neurodevelopmental disorders characterized by deficits in specific domains of reading (dyslexia), writing (dysorthographia/dysgraphia), or calculation (dyscalculia), in a relevant but defined way that leaves general intellectual functions intact. They have a neurobiological and genetic basis but are not related to neurological damage nor to significant socio-cultural disadvantages. However, SLDs can compromise personality development, social adaptation, and be associated with psychopathological disorders, both externalizing, i.e., oppositional, or defiant behaviour, and internalizing, i.e., anxious, and/or depressive traits, which can further impair a student's adaptation. In Italy, SLDs affect 3.5% of the school population; in Friuli Venezia Giulia (FVG), 3.1% of students are diagnosed with SLDs. Screening and early diagnosis play an important positive role in determining the evolution of the disorder and the overall emotional and cognitive development of children with SLDs. Diagnosis of disorders in reading and writing skills can only be made from the end of second grade in primary school. Italian and regional FVG regulations promote early identification of children with SLDs at school where, however, SLDs are often confused with learning difficulties, which affect approximately 20% of children and for which adequate reinforcement and targeted teaching methods are considered sufficient to improve reading and writing skills. This results in a high percentage of inappropriate referrals to the National Health Service (SSN) for SLD evaluation (40% false positives in 2023), leading to a lengthening of waiting times for a definitive SLD diagnosis.
The Guidelines of the Istituto Superiore di Sanità (ISS) recommend, as priority actions in first-grade primary school, phonological-metaphonological interventions to explicitly promote grapheme-phoneme association strategies for reading and writing. The literature supports these recommendations. Numerous studies have highlighted the essential role of Phonological Skills, demonstrating how systematic phonological methods are more helpful for children learning to read than all other methods and should therefore be implemented in schools. Furthermore, phonological skills also improve writing skills. This is further supported by evidence from the field of neuropsychology and from neuroscience using neuroimaging techniques. Dehaene has shown that a child learning to read needs to use the phonological pathway, which allows them to read a word by transcoding individual graphemes into their corresponding phonemes, thereby highlighting the neural circuits involved in grapheme-phoneme correspondence. On the contrary, having to pay attention to the overall shape of the word hinders the acquisition of the alphabetic code by directing brain activity towards an inadequate circuit.
The Alfabeto program is a rigorous, structured phono-syllabic approach that has been shown to be sustainable and effective in improving the reading and writing skills of all children in a quasi-experimental before-and-after study with a control group, conducted in first-grade classes during the 2019/2020 school year.
This randomized controlled trial aims to demonstrate that the Alfabeto program is superior for the acquisition of both reading and writing skills for all children, including those with learning difficulties or SLDs, compared to other teaching methods. If, as we expect, the program benefits all children, not only those with SLDs, the implementation of this method in a primary school setting should guarantee a reduction in inappropriate referrals for psychological evaluation and, consequently, in assessment waiting lists, thereby enabling true, accurate early detection of children with SLDs.
All FVG schools will be asked by the Regional School Office (USR) to join the project. School representatives will be invited to participate in a webinar to present the study and receive SLD training from specialized personnel. During the same period, family paediatricians will also be informed of the study's contents and objectives.
First-grade classes of schools that have accepted to take part in the project will be recruited. The randomization will be by class; therefore, all the children of the enrolled class, who do not have any of the exclusion criteria, will be assigned to a reading and writing learning method specified as follows:
Alfabeto is a structured phono-syllabic program, developed by SApIE Association (Society for Learning and Education informed by Evidence) starting from the working material of Dr. Ventriglia. It is:
Block randomization to either CG or EG will be performed by the SCR of Clinical Epidemiology and Public Health Research Unit using a computerized electronic random number generator.
Blocks will be single schools or school areas, so that first-grade classes within the same school or area will be paired and balanced by demographic and socio-cultural background. Given the experimental nature of the intervention, it will not be possible to ensure blindness.
Before the start of the school year, participating schools will be notified of the class assignment to EG or GC, and EG teachers will complete a 2-hour online synchronous training course on the Alfabeto program led by Dr. Ventriglia. She will also support EG teachers throughout the school year, both in the first and second grades, through monthly 2-hour synchronous online meetings.
EG teachers will receive the Teacher's Book to guide them step by step in applying the Alfabeto program, and EG children will receive the Child's Book, both in the first and second grades.
Parents of enrolled children will be adequately informed about the study at the beginning of the school year. They will be asked to sign informed consent for the administration of the validated tests used in the study, and a specific consent to privacy for the acquisition and storage of data collected through the study. Parents will also be asked to complete a questionnaire about the child and family (language spoken at home, age, parents' work and education, child's health problems, disability certification).
EG or CG teaching will start in September 2025 (start of first grade: T0) and will end in June 2027 (end of second grade: T2). At T0:
At T1:
At T2:
All SLD diagnoses will be documented and registered in a medical report inserted into the regional clinical system (G2). The medical report, including the functional profile and the impaired abilities, will be delivered to families and, through them to schools, after confirmation and countersignature by the authorized neuropsychiatrist/psychologist of the Child Neurology and Psychiatry Department.
Non-SLD children will be provided with tools to improve their reading and writing skills. SLD-confirmed children will enter the standard of care pathway, and all subsequent visits will be managed and paid through the (SSN) according to standard practices, including the payment of the 'ticket' by families that are not entitled to specific exemptions.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Children who will attend, starting in September 2025, first-grade classes of schools in the FVG region:
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)
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.
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.
Time frame: 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.
Time frame: 8 months from enrolment
Outcome variable is the reading time. It is a continuous variable and can get to a maximum of 4 minutes
Time frame: 8 months from enrolment
Collective integrated dictation test requires children to write 16 words of increasing phonological complexity with the addition of 2 trisyllable and 2 quadrisyllable words with complex consonant groups. The score will be given by assigning 1 point for each correct word and 0 points for each incorrect word. Both the word with errors within the graphemic structure (omissions, substitutions) and the word omitted or only partially transcribed will be considered incorrect. Only in the first grade, double letter errors and mirror writing are not considered. The outcome variable is continuous and can get to a maximum of 20.
Time frame: 20 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.
Time frame: 8 months from enrolment
Percentage
Time frame: 20 months from enrolment
Collective integrated dictation test requires children to write 16 words of increasing phonological complexity with the addition of 2 trisyllable and 2 quadrisyllable words with complex consonant groups. The score will be given by assigning 1 point for each correct word and 0 points for each incorrect word. Both the word with errors within the graphemic structure (omissions, substitutions) and the word omitted or only partially transcribed will be considered incorrect. Only in the first grade, double letter errors and mirror writing are not considered. The outcome variable is continuous and can get to a maximum of 20.
Time frame: 20 months from enrolment
Outcome variable is the reading time. It is a continuous variable and can get to a maximum of 4 minutes
Time frame: 20 months from enrolment
The test is structured in three parts: a. Write continuously, without lifting the pen from the paper, in cursive, the syllable "le" for one minute. In the evaluation, the number of correct pairs, in which both graphemes are recognizable, is counted and multiplied by 2; b. Write the word "uno", in cursive, for one minute. The evaluation considers the number of recognizable graphemes; c. Write the numbers in the word in order, starting from one, for one minute. The evaluation considers the number of recognizable graphemes. Total score is obtained summing the three sub-score and the outcome variable is continuous.
Time frame: 20 months from enrolment
Percentage
Time frame: 30 months from enrolment
Percentage
Time frame: 30 months from enrolment
Percentage
Time frame: 20 months from enrolment
Outcome variable is continuous and can be a negative number
Time frame: 8 months from enrolment
The MeTaFono is a phonological awareness test consisting of 16 closed-ended items. Each item is designed to evaluate the identification of phonological units across increasing levels of complexity, including initial phonemes (4 items), final phonemes (4 items), initial syllables (4 items), and final syllables (4 items).
Items are scored dichotomously: one point for each correct response and zero for each incorrect response. No partial credit is given, and incorrect responses are not penalized. The total score is computed by summing the number of correct responses, yielding a score range from 0 to 16, with higher scores indicating a more advanced level of phonological awareness. The outcome variable is continuous and can get to a maximum of 16.
Time frame: 20 months from enrolment
The MeTaFono is a phonological awareness test consisting of 16 closed-ended items. Each item is designed to evaluate the identification of phonological units across increasing levels of complexity, including initial phonemes (4 items), final phonemes (4 items), initial syllables (4 items), and final syllables (4 items).
Items are scored dichotomously: one point for each correct response and zero for each incorrect response. No partial credit is given, and incorrect responses are not penalized. The total score is computed by summing the number of correct responses, yielding a score range from 0 to 16, with higher scores indicating a more advanced level of phonological awareness. The outcome variable is continuous and can get to a maximum of 16.
IRCCS Burlo Garofolo
Other
Improvement of Reading and Writing Skills and Early Identification and Diagnosis of Specific Learning Disorders (SLD) Using a Structured Phonic-syllabic Program for First and Second Grade Primary School Children: a Randomized Controlled Trial
Acronym: ALFABETO
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