About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Healthy infants with and without familial risk for language impairments
Trial design
Cohort
Prospective
Treatments tested in this trial
Electrophysiological recording
Other interventionInvestigation of early neural markers using electrophysiology at 6-12-24 months
Behavioral assessment
BehavioralIndividual behavioral assessment at later ages (3, 4.5, 6, and 8 years)
Treatment groups
Trial outcomes
Primary outcomes
Expressive vocabulary at 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
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
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
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).
Secondary outcomes
Lexical access at age 4.5 years
Standardized score in Rapid Automatic Naming. Mean=10, Standard Deviation=3 (higher scores mean a better outcome).
Naming and articulatory accuracy at age 3 years
Raw scores in the test of naming and articulatory accuracy (created ad hoc). Scores are percentages of accuracy (higher scores mean a better outcome).
Nonverbal cognitive score at age 4.5 years
Standardized score in the block design subtest, taken from 'Wechsler Preschool and Primary Scale of Intelligence, 3rd edition'. Mean=10, Standard Deviation=3 (higher scores mean a better outcome).
Lexical access at age 6 years
Standardized score in Rapid Automatic Naming, taken from Urgesi et al., 2011. Z-scores are calculated (higher scores mean a better outcome).
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