Early Neurophysiological Markers of Language Impairments

NCT05767242 | Recruiting DMC

• 1 other identifier: 918
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (5)

• Lexical access at age 4.5 years

  Age 4.5 years

• Naming and articulatory accuracy at age 3 years

  Age 3 years

• Nonverbal cognitive score at age 4.5 years

  Age 4.5 years

• Lexical access at age 6 years

  Age 6 years

• Visual-motor integration at age 6 years

  Age 6 years

Study Arms (1)

MEDEA BabyLab Cohort

Other: Electrophysiological recording; Behavioral: Behavioral assessment

Interventions

Electrophysiological recording OTHER

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

MEDEA BabyLab Cohort

Behavioral assessment BEHAVIORAL

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

MEDEA BabyLab Cohort

Eligibility Criteria

• Age: 6 Months - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy infants with and without familial risk for language impairments

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

Associazione La Nostra Famiglia - IRCCS Eugenio Medea

Bosisio Parini, LC, 23842, Italy

RECRUITING

MeSH Terms

Conditions

Language; Language Development Disorders; Learning Disabilities

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Communication; Behavior; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

Chiara Cantiani, PhD

CONTACT

+39031877924; chiara.cantiani@lanostrafamiglia.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: March 14, 2023
• Study Start: February 21, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)