Clinical trial NCT06947512: Personalization of Visual Characters and Text-to-Speech (TTS) to Support Learning in Students With Reading Difficulties
Official title: Efficacy of the Personalization of Visual Parameters and Text-to-Speech to Improve Reading Speed, Accuracy and Comprehension in Students With Learning Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Developmental Dyslexia
Reading Problem
Keywords: Developmental Dyslexia
Reading Difficulties
Personalization
Visual parameters
Auditory parameters
Fonts
Text-to-Speech (TTS)
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 90
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each of the participants will be tested in two conditions: with personalized parameters and with standard parameters. Their performance in reading and writing to dictation will be compared in a single-group, within-subjects model. A post-hoc comparison will also be conducted to confirm the validity of the procedure by assessing the existence of the predicted between-groups differences in reading and writing performance.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Previous research has shown the importance of font type, size and spacing to facilitate text reading in dyslexia. A special automatized procedure was designed to select the most favorable parameters for both text visualization and text-to-speech (TTS) conversion to be used by students with reading difficulties. The validation of its outcomes will be carried out through a systematic comparison of the use of the personalized versus standard fonts and voices in reading and writing tests.

Detailed description: Seleggo is a free compensatory tool for dyslexic students. It is an online platform where school textbooks are transcribed and visualized on the screen in portable format (PDF) versions, characterized by special attention to graphical features and readability, and can be listened to via TTS technology. Special functions such as karaoke modality, conceptual maps building software, summary creation, verbal and visual definition search and the possibility to record and retrieve one's own notes and sketches are also provided. Each student with Specific learning Disorder (SLD) has a personal library and can choose the parameters for text visualization to facilitate reading, modifying the display of the text, choosing font, size and spacing, as well as TTS parameters, such as speed and pitch.

The availability of many options for text visualization and TTS, however, can be advantageous only as far as the students are able to choose and use parameters that objectively facilitate their reading and comprehension. Since the analysis of the literature suggests that subjective choices may be misleading and that general recommendations may not fit the individual's needs, we decided to build an automatized, as objective as possible procedure to help the students find the combination of parameters that is most likely to facilitate them in reading and studying. This procedure, composed by an initial, gross-grained subjective procedure and followed by a thorough, systematic analysis of reading and comprehension performance, was named "Seleggo test" to match the compensatory tool it was meant to complement.

The present study aims to assess the actual advantage of personalized parameter selection through the "Seleggo Test" procedure in supporting reading compared to the use of standard parameters. The working hypothesis is that children with reading disorders would benefit from personalized text features and TTS.

The recruitment of participants will take place in schools. It is foreseen that 30 participants are recruited for each of the three groups: typically Developing children (TD), Developmental Dyslexia (DD) and Special Educational Needs (SEN) - with reading difficulties).

Additional children will be recruited form patients with DD at Scientific Institute (IRCCS) E. Medea, if necessary to reach the expected number. Children will attend the third grade of primary school to the third grade of middle school (7 to 15 years old).

Eligibility criteria: Inclusion Criteria (for TD group):

* age 7-15 years
* no history of reading difficulties
* attends school in Italy

Exclusion Criteria (for TD group):

* special educational needs or diagnosis of neurodevelopmental disorders

Inclusion Criteria (for DD group):

* age 7-15 years
* diagnosis of Developmental Dyslexia or Specific Reading Disorder
* Attends school in Italy

Exclusion Criteria (for DD group):

* diagnosis of Intellectual Disability

Inclusion Criteria (for SEN group):

* age 7-15 years
* reported by school to have significant difficulties in reading and writing
* Attends school in Italy (at least 6 months continued schooling and exposure to the Italian language)

Exclusion Criteria (for SEN group):

* diagnosis of Intellectual Disability

Primary outcomes:
measure: Reading facilitation (speed), i.e. the advantage in reading performance (speed) produced by personalized parameters as compared to standard parameters
timeFrame: Intervention will take place during initial assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
measure: Reading facilitation (accuracy), i.e. the advantage in reading performance (accuracy) produced by personalized parameters as compared to standard parameters
timeFrame: Intervention will take place during initial assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
measure: Comprehension facilitation, i.e. the advantage in auditory comprehension performance produced by personalized TTS parameters as compared to standard parameters
timeFrame: Intervention will take place during initial assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
Secondary outcomes:
measure: possibility to discriminate TD students' reading speed from that of students with DD and SEN
timeFrame: about 10 months
measure: possibility to discriminate TD students's reading accuracy from that of students with DD and SEN
timeFrame: about 10 months
measure: possibility to discriminate TD students' writing accuracy from that of students with DD and SEN
timeFrame: about 10 months
measure: validity and reliability values for the reading speed measures collected by the software
timeFrame: about 10 months
measure: validity and reliability values for the reading accuracy measures collected by the software
timeFrame: about 10 months
measure: validity and reliability values for the writing accuracy measures collected by the software
timeFrame: about 10 months
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS E. Medea, polo di Bosisio Parini
state: LC
city: Conegliano
country: Italy
facility: IRCCS E.Medea, polo di Conegliano
state: TV
city: Treviso
country: Italy
facility: Associazione La Nostra Famiglia
state: TV
Study officials:
References:
citation: Lorusso ML, Borasio F, Panetto P, Curioni M, Brotto G, Pons G, Carsetti A, Molteni M. Validation of a Web App Enabling Children with Dyslexia to Identify Personalized Visual and Auditory Parameters Facilitating Online Text Reading. Multimodal Technologies and Interaction. 2024; 8(1):5.