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Early Neurophysiological Markers of Language Impairments

Early Neurophysiological Markers of Language Impairments: a Longitudinal Study on Infants At Familial Risk

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05767242
Enrollment
100
Registered
2023-03-14
Start date
2022-02-21
Completion date
2026-12-31
Last updated
2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental Language Disorder, Development, Infant, Development, Language, Learning Disabilities

Brief 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.

Interventions

Investigation of early neural markers using electrophysiology at 6-12-24 months

Individual behavioral assessment at later ages (3, 4.5, 6, and 8 years)

Sponsors

IRCCS Eugenio Medea
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 8 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Phonemic awareness at age 8 yearsAge 8 yearsRaw 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).
Phonological awareness at age 4.5 yearsAge 4.5 yearsStandardized 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 yearsAge 6 yearsComposite 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 yearsAge 6 yearsRaw 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 yearsAge 8 yearsStandardized 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 yearsAge 8 yearsStandardized scores in the spelling task (Marinelli et al., 2016). Z-scores are calculated (higher scores mean a better outcome).
Expressive vocabulary at age 3 yearsAge 3 yearsStandardized 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 yearsAge 3 yearsRaw 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 yearsAge 3 yearsStandardized 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 yearsAge 3 yearsRaw 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 yearsAge 4.5 yearsStandardized 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).

Secondary

MeasureTime frameDescription
Naming and articulatory accuracy at age 3 yearsAge 3 yearsRaw 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 yearsAge 4.5 yearsStandardized 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 yearsAge 6 yearsStandardized score in Rapid Automatic Naming, taken from Urgesi et al., 2011. Z-scores are calculated (higher scores mean a better outcome).
Visual-motor integration at age 6 yearsAge 6 yearsStandardized score in the 'Developmental Test of Visual-Motor Integration', Preda, 2000. Minimum=5; Maximum=95 (higher scores mean a better outcome).
Lexical access at age 4.5 yearsAge 4.5 yearsStandardized score in Rapid Automatic Naming. Mean=10, Standard Deviation=3 (higher scores mean a better outcome).

Countries

Italy

Contacts

Primary ContactChiara Cantiani, PhD
chiara.cantiani@lanostrafamiglia.it+39031877924

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026