Early Neurophysiological Markers of Language Impairments: a Longitudinal Study on Infants At Familial Risk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reading (accuracy, speed and comprehension) at age 8 years
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Reading (accuracy, speed and comprehension) at age 8 years
时间窗: 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).
Lexical comprehension at age 3 years
时间窗: 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).
Phonological awareness at age 4.5 years
时间窗: 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).
Expressive vocabulary at age 3 years
时间窗: 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).
Phonological awareness at age 3 years
时间窗: Age 3 years
Raw 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 years
时间窗: 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).
Short-term verbal memory at age 4.5 years
时间窗: 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).
Phonological awareness at age 6 years
时间窗: 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).
Letter identification, knowledge, and writing at age 6 years
时间窗: 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).
Spelling at age 8 years
时间窗: Age 8 years
Standardized scores in the spelling task (Marinelli et al., 2016). Z-scores are calculated (higher scores mean a better outcome).
Phonemic awareness at age 8 years
时间窗: 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).
次要结局
- Nonverbal cognitive score at age 4.5 years(Age 4.5 years)
- Visual-motor integration at age 6 years(Age 6 years)
- Lexical access at age 4.5 years(Age 4.5 years)
- Naming and articulatory accuracy at age 3 years(Age 3 years)
- Lexical access at age 6 years(Age 6 years)