Reading-FREE Markers for Early Detection of Developmental Dyslexia

Sponsor
Università Vita-Salute San Raffaele
Study ID
NCT07072104
Status
Enrolling By Invitation

Conditions

  • Developmental Dyslexia
  • Preterm Birth

Eligibility Criteria

Sex
ALL
Age
6 Years - 9 Years
Healthy Volunteers
Accepted

Interventions

  • Multidomain Neuropsychological and Reading-Free Screening Tool (RSFT) Assessment Battery - Grade 2 — BEHAVIORAL
    * Behavioral testing: standardized neuropsychological battery (language, reading, attention, memory, intelligence) * RFST: Reading-Free Screening Tool assessing pre-reading cognitive markers
  • MRI - Grade 2 — DIAGNOSTIC_TEST
    ■ Diagnostic Imaging: structural and resting-state functional MRI (T1-weighted and rs-fMRI)
  • Multidomain Neuropsychological and Reading-Free Screening Tool (RSFT) Assessment Battery - Grade 3 — BEHAVIORAL
    * Behavioral testing: standardized neuropsychological battery (language, reading, attention, memory, intelligence) * RFST: Reading-Free Screening Tool assessing pre-reading cognitive markers

Study Details

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.

Key Dates

First listed
Jul 18, 2025
Start date
Jul 31, 2025
Status verified
Jul 2025
Primary completion
Jan 31, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: PTB
    Preterm-born children group
  • Experimental: ATB
    At-term-born children group

Primary Outcome Measure

Change in RFST Auditory Modality Composite Score From Grade 2 to Grade 3 in Preterm Children [ Time Frame: From Grade 2 baseline to Grade 3 follow-up assessment (approx. 8-10 months) ]

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