Longitudinal Assessment of Multidomain Reading-FREE Neurocognitive Markers for Early Detection of Developmental Dyslexia (FREE-DD)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in RFST Auditory Modality Composite Score From Grade 2 to Grade 3 in Preterm Children
研究概览
简要总结
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.
详细描述
This longitudinal study, titled "Longitudinal assessment of multidomain reading-FREE neurocognitive markers for early detection of Developmental Dyslexia (FREE-DD)", investigates early neurocognitive predictors of developmental dyslexia (DD) and related reading disorders in children born preterm (PTB), as compared to children born at term (ATB). Children born preterm are at elevated risk for neurodevelopmental vulnerabilities, including difficulties with language, attention, and reading acquisition, yet early identification of these risks remains limited.
The main objective of the study is to identify early connectomic and neurocognitive markers-obtained during second grade-that can predict the development of reading difficulties in PTB children by third grade. Particular emphasis is placed on connectomic features derived from functional and structural brain imaging, as well as on a specially designed behavioral tool: the Reading-Free Screening Tool (RFST), which assesses reading-related cognitive abilities without requiring the child to read.
The study adopts a prospective, longitudinal, monocentric cohort design, with two assessment waves:
- Grade 2 (Baseline/Timepoint 1): All enrolled children will undergo a comprehensive neuropsychological battery, RFST administration, and MRI acquisition (including structural and resting-state functional MRI).
- Grade 3 (Follow-up/Timepoint 2): Children will be reassessed using the RFST and neuropsychological tests to track changes in cognitive and reading-related abilities.
The study population includes 30 preterm-born (PTB) children and 15 term-born (ATB) children, all aged between 6 and 9 years, native Italian speakers, and right-handed. Children with structural brain lesions, congenital anomalies, or known neurological/psychiatric conditions will be excluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Preterm-Born (PTB) Children:
- •Born preterm (i.e., gestational age < 39 weeks)
- •Aged between 6 and 9 years at enrollment
- •Absence of structural brain lesions (as assessed by prior clinical imaging)
- •Italian as the first language (L1)
- •Right-hand dominant
- •Male or female
- •For At-Term-Born (ATB) Children:
- •Born at term (i.e., gestational age between 39 and 42 weeks)
- •Aged between 6 and 9 years at enrollment
- •Absence of structural brain lesions (as assessed by prior clinical imaging)
- •Italian as the first language (L1)
- •Right-hand dominant
- •Male or female
排除标准
- •For Preterm-Born (PTB) Children:
- •History of congenital infections
- •Diagnosis of Multiple Congenital Anomalies Syndrome
- •Presence of focal intracerebral parenchymal lesions
- •Pathological findings on conventional MRI
- •For At-Term-Born (ATB) Children:
- •Presence of first-degree relatives diagnosed with developmental dyslexia (DD)
- •Diagnosis of other learning or behavioral disorders
- •Contraindications to MRI (e.g., metal implants, severe claustrophobia)
研究组 & 干预措施
ATB
At-term-born children group
干预措施: MRI - Grade 2 (Diagnostic Test)
PTB
Preterm-born children group
干预措施: Multidomain Neuropsychological and Reading-Free Screening Tool (RSFT) Assessment Battery - Grade 2 (Behavioral)
PTB
Preterm-born children group
干预措施: MRI - Grade 2 (Diagnostic Test)
PTB
Preterm-born children group
干预措施: Multidomain Neuropsychological and Reading-Free Screening Tool (RSFT) Assessment Battery - Grade 3 (Behavioral)
ATB
At-term-born children group
干预措施: Multidomain Neuropsychological and Reading-Free Screening Tool (RSFT) Assessment Battery - Grade 2 (Behavioral)
ATB
At-term-born children group
干预措施: Multidomain Neuropsychological and Reading-Free Screening Tool (RSFT) Assessment Battery - Grade 3 (Behavioral)
结局指标
主要结局
Change in RFST Auditory Modality Composite Score From Grade 2 to Grade 3 in Preterm Children
时间窗: From Grade 2 baseline to Grade 3 follow-up assessment (approx. 8-10 months)
Composite score summarizing auditory-based sensorimotor, timing, discrimination, and inhibitory control abilities measured via the ReadFree Screening Tool (RFST) auditory modality tasks. Includes: * Auditory Reaction Time (median RTs of 8 trials) * Tapping and Entrainment to Metronome (tapping onset) * Free Tapping (motor rhythm without auditory cue) * Tone Discrimination (smallest perceptible pitch interval) * Cocktail Party Task (d-prime, target detection in multitalker noise) * Auditory Go/No-Go (d-prime, inhibition) * Auditory Anticipatory Timing (tapping onset accuracy) Each task is z-scored and aggregated into a single composite. Higher scores indicate better auditory sensorimotor and temporal processing.
Change in RFST Visual Modality Composite Score From Grade 2 to Grade 3 in Preterm Children
时间窗: From Grade 2 baseline to Grade 3 follow-up assessment (approx. 8-10 months)
Composite score summarizing visual-based sensorimotor, discrimination, and inhibitory control abilities from the RFST visual modality tasks. Includes: * Visual Reaction Time (median RTs of 8 trials) * Tapping and Entrainment to Visual Cue (tapping onset) * Free Tapping (motor rhythm without visual cue) * Grey-Scale Discrimination (smallest perceptible luminance interval) * Visual Go/No-Go (d-prime, visual inhibition) * Visual Anticipatory Timing (accuracy of tapping onset) * RAN-Shapes (number of shapes named in 30s) Each score is converted to z-units and averaged to yield a composite metric. Higher scores indicate better visual-motor and perceptual timing performance.
Grade 2 Composite Language Score in Preterm Children
时间窗: Grade 2 baseline assessment
A standardized composite language score derived from z-transformed or scalar scores of the following assessments: * Phoneme Deletion * BVL Auditory Discrimination (HIT-False Alarm Index, range: -100% to +100%) * NEPSY-II Subtests: L1, L3, L4, L5. The composite reflects mean z-scores (normalized against internal sample distribution) across all measures. Higher scores indicate better language functioning.
Grade 2 Composite Attention Score in Preterm Children
时间窗: Grade 2 baseline assessment
A composite attention score computed from standardized or scalar scores across the following assessments: * Colored Raven Matrices (Percentiles by age: 3rd-95th) * NEPSY-II Subtests: * A1 Visual Search * A2 Figural Fluency * A3 Auditory Attention * A4 Inhibition (Time; Accuracy) * A6 Categorization Each test is converted to a z-score and averaged for a domain-wide summary score. Higher scores indicate better attention performance.
Grade 2 Composite Reading Score in Preterm Children
时间窗: Grade 2 baseline assessment
Composite score combining metrics from multiple timed and accuracy-based reading assessments: * Lapel Reading Song (Words per minute: 21-157; Errors: 0-10) * PIN Reading (Words and Pseudo-words): * Reading Time * Syllables/sec * Number of Errors Each metric is z-normalized and averaged per task, then aggregated for a domain-level composite. Higher composite scores indicate better learning performance.
Grade 2 Resting-State fMRI Network Segregation Score in Preterm Children
时间窗: Grade 2 baseline MRI session
Resting-state functional connectivity-based modularity score, measuring the extent to which functional networks in the brain are subdivided into non-overlapping, highly interconnected communities. Higher modularity indicates greater network segregation.
Grade 2 Resting-State fMRI Network Integration Score in Preterm Children
时间窗: Grade 2 baseline MRI session
Participation coefficient derived from resting-state fMRI data, quantifying the extent to which brain nodes form diverse intermodular connections. Higher participation coefficient reflects greater network integration and communication between functional modules.
次要结局
- Composite Reading Score at Grade 3 in Preterm Children(Grade 3 follow-up assessment)
- Composite Attention Score at Grade 3 in Preterm Children(Grade 3 follow-up assessment (8-10 months post-baseline))
- Language Score at Grade 3 in Preterm Children(Grade 3 follow-up assessment)
研究者
Andrea Falini
Full Professor of Neuroradiology
Università Vita-Salute San Raffaele