Early Neurophysiological Markers of Language Impairments

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

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.

Study Overview

• Status: Recruiting
• Conditions: Learning Disabilities; Development, Infant; Developmental Language Disorder; Development, Language
• Intervention / Treatment: Other: Electrophysiological recording; Behavioral: Behavioral assessment

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Chiara Cantiani, PhD; Phone Number: +39031877924; Email: chiara.cantiani@lanostrafamiglia.it

Study Locations

• Italy
  • LC
    • Bosisio Parini, LC, Italy, 23842
      • Recruiting
      • Associazione La Nostra Famiglia - IRCCS Eugenio Medea
      • Contact: Chiara Cantiani, PhD; Phone Number: +39031877924; Email: chiara.cantiani@lanostrafamiglia.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy infants with and without familial risk for language impairments

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MEDEA BabyLab Cohort	Other: Electrophysiological recording; Investigation of early neural markers using electrophysiology at 6-12-24 months; Behavioral: Behavioral assessment; Individual behavioral assessment at later ages (3, 4.5, 6, and 8 years)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Age 3 years
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).	Age 3 years
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).	Age 3 years
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).	Age 3 years
Short-term verbal memory at 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).	Age 4.5 years
Phonological awareness at 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).	Age 4.5 years
Phonological awareness at 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).	Age 6 years
Letter identification, knowledge, and writing at 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).	Age 6 years
Reading (accuracy, speed and comprehension) at 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).	Age 8 years
Spelling at age 8 years	Standardized scores in the spelling task (Marinelli et al., 2016). Z-scores are calculated (higher scores mean a better outcome).	Age 8 years
Phonemic awareness at 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).	Age 8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lexical access at age 4.5 years	Standardized score in Rapid Automatic Naming. Mean=10, Standard Deviation=3 (higher scores mean a better outcome).	Age 4.5 years
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).	Age 3 years
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).	Age 4.5 years
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).	Age 6 years
Visual-motor integration at age 6 years	Standardized score in the 'Developmental Test of Visual-Motor Integration', Preda, 2000. Minimum=5; Maximum=95 (higher scores mean a better outcome).	Age 6 years

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Language Disorders; Learning Disabilities; Language Development Disorders
• Other Study ID Numbers: 918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No