Electrophysiological recording: Investigation of early neural markers using electrophysiology at 6-12-24 months
Behavioral assessment: Individual behavioral assessment at later ages (3, 4.5, 6, and 8 years)
Study summary
The present project aims at identifying very early electrophysiological risk markers for language impairments. The long-term goals of the study include the characterization of learning developmental trajectories in children at high risk for language impairments. In this project, all the infants of the Medea BabyLab cohort are followed-up until school age. Since these infants have complete information on early electrophysiological markers, the final goal of the project is the characterization of their learning developmental trajectories and the construction of a multi-factor prognostic model that includes the neurophysiological processes underlying basic-level skills as potential biomarkers for predicting later reading and spelling skills.
Eligibility
Sex
ALL
Min age
6 Months
Max age
8 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Healthy infants aged \<24 months
* Infants with and without familial risk for language impairments (infants are assigned to the group with familial risk if at least one first-degree relative had a certified (clinical) diagnosis of language impairment or learning disability
* Both parents are native-Italian speakers
Exclusion Criteria:
* Gestational age \< 37 weeks and/or birth weight \< 2500 grams
* APGAR scores at birth at 1' and 5' \< 7
* Bayley Cognitive Score \< 7
* Presence of certified diagnosis of intellectual deficiency, attention-deficit disorder, sensorial and neurological disorders, or autism within first-degree relative
Primary outcome measure(s)
Expressive vocabulary at age 3 years — Age 3 years Standardized score in the Language Development Survey (Rescorla, 1989; Rescorla et al., 2014). Minimum=5; Maximum=95 (higher scores mean a better outcome).
Phonological awareness at age 3 years — Age 3 years Raw score in a syllabic blending task (created ad hoc). Scores are percentages of accuracy (higher scores mean a better outcome).
Syntactic comprehension at age 3 years — Age 3 years Standardized scores in the syntactic comprehension subtests, taken from 'Test for language evaluation', Cianchetti e Fancello, 1997. Z-scores are calculated (higher scores mean a better outcome).
Lexical comprehension at age 3 years — Age 3 years Raw score in the lexical comprehension subtest, taken from 'Battery for language evaluation in children 4-12 years', Marini et al., 2015. Scores are percentages of accuracy (higher scores mean a better outcome).
Short-term verbal memory at age 4.5 years — Age 4.5 years Standardized scores in the pseudo-word repetition subtest, taken from 'Battery for language evaluation in children 4-12 years', Marini et al., 2015. Z-scores are calculated (higher scores mean a better outcome).
Phonological awareness at age 4.5 years — Age 4.5 years Standardized scores in the phonological awareness subtests taken from 'Evaluation of phonological awareness skills', Marotta et al., 2008. Mean=10, Standard Deviation=3 (higher scores mean a better outcome).
Phonological awareness at age 6 years — Age 6 years Composite score of the standardized scores in the phonological awareness subtests (phoneme identification, phonemic segmentation), Cornoldi et al., 2009. Z-scores are calculated (higher scores mean a better outcome).
Letter identification, knowledge, and writing at age 6 years — Age 6 years Raw scores in the letter identification, knowledge, and writing subtests, taken from "Preschool Screening", Savelli et al., 2013. Minimum=0, Maximum=20 (higher scores mean a better outcome).
Reading (accuracy, speed and comprehension) at age 8 years — Age 8 years Standardized scores in the reading subtest, taken from 'Reading and comprehension assessment', Bonifacci et al., 2014. Z-scores are calculated (higher scores mean a better outcome).
Spelling at age 8 years — Age 8 years Standardized scores in the spelling task (Marinelli et al., 2016). Z-scores are calculated (higher scores mean a better outcome).
Phonemic awareness at age 8 years — Age 8 years Raw scores in the spoonerisms subtest taken from 'Evaluation of phonological awareness skills', Marotta et al., 2008. Minimum=0, Maximum=30 (higher scores mean a better outcome).
Trial sites (1)
Facility
City
Region
Status
Associazione La Nostra Famiglia - IRCCS Eugenio Medea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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