Genetic Biomarkers of Child Language Development in Taiwan: an Identification and Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Scores of cognitive function 1
研究概览
简要总结
A study of the relation between genetic biomarkers and child language development in Taiwan.
详细描述
The interaction between gene and environment (G×E) can be a very complicated process that influences child development. As a pilot study of child development biomarkers, this study investigates genes related to child language development and language disorder.
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
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 2-18 y/o
- •Agree to sign informed consent
排除标准
- •Central nervous system disease
- •Neuromuscular Disorders
- •Congenital Abnormality
- •Genetic Disease
- •Dysesthesia
- •Hearing Impairment
- •Inclusion Criteria of Child with language disorder:
- •Patients with Language Disorder
- •Age 2-18 y/o
- •Agree to sign informed consent
- •Exclusion Criteria of Child with language disorder:
- •Hearing Impairment
- •Inclusion Criteria of Adult:
- •His or her child participated in this study, and gene abnormality was found.
结局指标
主要结局
Scores of cognitive function 1
时间窗: baseline
Bayley Scales of Infant and Toddler Development (Scores from 0 to 140, higher scores mean a better outcome.)
Scores of language function 1
时间窗: baseline
Peabody Picture Vocabulary Test-Revised (Scores from 0 to 124, higher scores mean a better outcome.)
Scores of cognitive function (2 y/o to 6 y/o)
时间窗: baseline
Wechsler Preschool and Primary Scale of Intelligence (Scores from 0 to 200, higher scores mean a better outcome.)
Scores of cognitive function (6 y/o to 16 y/o)
时间窗: baseline
Wechsler Intelligence Scale for Children (Scores from 0 to 200, higher scores mean a better outcome.)
Scores of language function 2
时间窗: baseline
Preschool Language Impaired Scale(PLS)/Language Impaired Scale(LS) (PLS: Scores from 0 to 65, higher scores mean a better outcome. LS: Scores from 0 to 73, higher scores mean a better outcome.)
Scores of general development
时间窗: baseline
Comprehensive Developmental Inventory for Infants and Toddlers (Higher scores mean a better outcome.)
Scores of cognitive function 3
时间窗: baseline
Test of Nonverbal Intelligence-Fourth Edition (Scores from 0 to 60, higher scores mean a better outcome.)
Gene test 1
时间窗: baseline
Microarray (Use Axiom Genome-Wide TWB 2.0 Array Plate (TWB 2.0) to analyze SNPs of disease-related biomarkers.)
Gene test 2
时间窗: baseline
Whole-Exome Sequencing (Use Burrows-Wheeler Aligner (BWA) 85, Samtools86, Picard, Genome Analysis Toolkit (GATK) to screen out the variant discovery and genotyping.)
次要结局
- Scores of activities(baseline)
- Scores of participation(2-5 y/o)(baseline)
- Scores of participation(>6 y/o(baseline)
- Scores of quality of life(baseline)