Early Neurophysiological Markers of Language Impairments

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-8
SponsorIRCCS Eugenio Medea

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Electrophysiological recording

    Other intervention

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

  • Behavioral assessment

    Behavioral

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: MEDEA BabyLab Cohort2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Age 3 years
2

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).

Time frame
Age 3 years
3

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).

Time frame
Age 3 years
4

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).

Time frame
Age 3 years

Secondary outcomes

1

Lexical access at age 4.5 years

Standardized score in Rapid Automatic Naming. Mean=10, Standard Deviation=3 (higher scores mean a better outcome).

Time frame
Age 4.5 years
2

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).

Time frame
Age 3 years
3

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).

Time frame
Age 4.5 years
4

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).

Time frame
Age 6 years

Other outcomes

Sponsors and contacts

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