Reading-FREE Markers for Early Detection of Developmental Dyslexia

Summary

This study aims to identify early signs of developmental dyslexia (DD) and other reading difficulties in children born preterm, using behavioral, cognitive, and brain imaging data collected before reading problems typically become noticeable. Children born very early often face greater risk for reading and learning challenges, but these difficulties are not always detected in time for early support. This research seeks to fill that gap. A group of 30 children born preterm will be followed over time, alongside a control group of 15 children born at term. All children will be assessed during the second and third years of primary school (around ages 6-9). In Grade 2, children will undergo (a) a specially designed digital screening tool for reading difficulties that does not require actual reading (called the RFST), (b) standard tests of reading, language, and attention, and (c) structural and functional brain scans using Magnetic Resonance Imaging (MRI). In Grade 3, the children will be reassessed using the RFST and the cognitive and language tests. The goal is to identify specific behavioral and brain-based markers-particularly patterns of brain connectivity-that are already present in Grade 2 and can predict which children will go on to show reading difficulties in Grade 3. By comparing data from preterm and term-born children, researchers aim to discover early warning signs that are specific to children born preterm. By detecting these risks early, before reading delays become severe, the study hopes to guide new tools for screening and early intervention, tailored specifically to the unique developmental paths of children born preterm. This could help prevent later academic struggles and promote better long-term outcomes.

Conditions

• Preterm Birth
• Developmental Dyslexia

Interventions

BEHAVIORAL

Multidomain Neuropsychological and Reading-Free Screening Tool (RSFT) Assessment Battery - Grade 2

* Behavioral testing: standardized neuropsychological battery (language, reading, attention, memory, intelligence) * RFST: Reading-Free Screening Tool assessing pre-reading cognitive markers

DIAGNOSTIC_TEST

MRI - Grade 2

■ Diagnostic Imaging: structural and resting-state functional MRI (T1-weighted and rs-fMRI)

BEHAVIORAL

Multidomain Neuropsychological and Reading-Free Screening Tool (RSFT) Assessment Battery - Grade 3

* Behavioral testing: standardized neuropsychological battery (language, reading, attention, memory, intelligence) * RFST: Reading-Free Screening Tool assessing pre-reading cognitive markers

Sponsors & Collaborators

• University of Urbino "Carlo Bo"

  collaborator OTHER

• University of Milano Bicocca

  collaborator OTHER

• Università Vita-Salute San Raffaele

  lead OTHER

Principal Investigators

• Andrea Falini, Doctor of Medicine · 1. Vita-Salute San Raffaele University, Milan, Italy 2. Neuroradiology Unit and CERMAC, IRCCS Ospedale San Raffaele, Milan, Italy

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-07-31

Primary Completion

2026-01-31

Completion

2026-02-28

Countries

• Italy

Study Locations