Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05767242

Early Neurophysiological Markers of Language Impairments

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Development, Infant Behavior Communication Communication Disorders Development, Language Developmental Language Disorder Language Language Development Disorders Language Disorders Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 month–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Associazione La Nostra Famiglia - IRCCS Eugenio Medea

Bosisio Parini, LC, 23842, Italy

Location status: Recruiting

Location contact

Chiara Cantiani, PhD

CONTACT

[email protected]

+39031877924

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrophysiological recording

Other

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)

Primary outcomes

  1. Expressive vocabulary at age 3 years

    Time frame: 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).

  2. Phonological awareness at age 3 years

    Time frame: Age 3 years

    Raw score in a syllabic blending task (created ad hoc). Scores are percentages of accuracy (higher scores mean a better outcome).

  3. Syntactic comprehension at age 3 years

    Time frame: 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).

  4. Lexical comprehension at age 3 years

    Time frame: 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).

  5. Short-term verbal memory at age 4.5 years

    Time frame: 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).

  6. Phonological awareness at age 4.5 years

    Time frame: 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).

  7. Phonological awareness at age 6 years

    Time frame: 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).

  8. Letter identification, knowledge, and writing at age 6 years

    Time frame: 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).

  9. Reading (accuracy, speed and comprehension) at age 8 years

    Time frame: 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).

  10. Spelling at age 8 years

    Time frame: Age 8 years

    Standardized scores in the spelling task (Marinelli et al., 2016). Z-scores are calculated (higher scores mean a better outcome).

  11. Phonemic awareness at age 8 years

    Time frame: 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).

Secondary outcomes

  1. Lexical access at age 4.5 years

    Time frame: Age 4.5 years

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

  2. Naming and articulatory accuracy at age 3 years

    Time frame: 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).

  3. Nonverbal cognitive score at age 4.5 years

    Time frame: 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).

  4. Lexical access at age 6 years

    Time frame: 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).

  5. Visual-motor integration at age 6 years

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Cantiani, PhD

CONTACT

[email protected]

+39031877924

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 14, 2023
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.