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
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 1,407
- 试验地点
- 1
- 主要终点
- Difference in mean DLC score between EG and GC groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Children who need differentiated teaching programming with a dedicated teacher (L.104 Comma 1 e 3)
研究组 & 干预措施
Experimental Group (EG)
The Experimental Group (EG) will follow the Alfabeto reading and writing method in first and second grade.
干预措施: Alfabeto program (Other)
Control Group (CG)
The control group (CG) will comply with any of the standard literacy teaching methods used in Italian schools to teach reading and writing to first graders.
干预措施: Other literacy teaching methods (Other)
结局指标
主要结局
Difference in mean DLC score between EG and GC groups
时间窗: 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.
次要结局
- Difference in diagnosed SLD/'presumed SLD' percentage between EG and GC groups(30 months from enrolment)
- Difference in mean MT score between EG and GC groups(8 months from enrolment)
- Difference in mean word dictation score between EG and GC groups(8 months from enrolment)
- Difference in mean DLC score between EG and GC groups(20 months from enrolment)
- Difference in 'presumed SLD' prevalence between EG and GC groups(8 months from enrolment)
- Difference in mean word dictation score between EG and GC groups(20 months from enrolment)
- Difference in mean MT score between EG and GC groups(20 months from enrolment)
- Difference in mean writing BVSCO score between EG and GC groups(20 months from enrolment)
- Difference in prevalence of 'presumed SLD' (sent for clinical evaluation) between EG and GC groups(20 months from enrolment)
- Difference in diagnosed SLD prevalence between EG and GC groups(30 months from enrolment)
- Difference in mean T2-T1 scores, for all standardized tests, between EG and GC groups(20 months from enrolment)
- Difference in mean meta-phonological (METAFONO) score between the EG and GC groups(8 months from enrolment)
- Difference in mean meta-phonological (METAFONO) score between the EG and GC groups(20 months from enrolment)
