Genetic Biomarkers of Child Language Development in Taiwan: an Identification and Validation Study

Study Overview
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Brief Summary
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A study of the relation between genetic biomarkers and child language development in Taiwan.

Detailed Description
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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.

Official Title
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Genetic Biomarkers of Child Language Development in Taiwan: an Identification and Validation Study

Conditions
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Child Language

Intervention / Treatment
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* Genetic: The experiment does not required any intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 2-18 y/o Agree to sign informed consent Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>healthy child | |
| Experimental group<br>parents with language disorder | Genetic: The experiment does not required any intervention<br>* The experiment does not required any intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of cognitive function 1 | Bayley Scales of Infant and Toddler Development (Scores from 0 to 140, higher scores mean a better outcome.) | baseline | 
| Scores of cognitive function (2 y/o to 6 y/o) | Wechsler Preschool and Primary Scale of Intelligence (Scores from 0 to 200, higher scores mean a better outcome.) | baseline | 
| Scores of cognitive function (6 y/o to 16 y/o) | Wechsler Intelligence Scale for Children (Scores from 0 to 200, higher scores mean a better outcome.) | baseline | 
| Scores of cognitive function 3 | Test of Nonverbal Intelligence-Fourth Edition (Scores from 0 to 60, higher scores mean a better outcome.) | baseline | 
| Scores of language function 1 | Peabody Picture Vocabulary Test-Revised (Scores from 0 to 124, higher scores mean a better outcome.) | baseline | 
| Scores of language function 2 | 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.) | baseline | 
| Scores of general development | Comprehensive Developmental Inventory for Infants and Toddlers (Higher scores mean a better outcome.) | baseline | 
| Gene test 1 | Microarray (Use Axiom Genome-Wide TWB 2.0 Array Plate (TWB 2.0) to analyze SNPs of disease-related biomarkers.) | baseline | 
| Gene test 2 | Whole-Exome Sequencing (Use Burrows-Wheeler Aligner (BWA) 85, Samtools86, Picard, Genome Analysis Toolkit (GATK) to screen out the variant discovery and genotyping.) | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of participation(2-5 y/o) | Assessment of Preschool Children's Participation (Scores from 0 to 45, higher scores mean a better outcome.) | baseline | 
| Scores of participation(>6 y/o | Children Assessment of Participation and Enjoyment and Preferences for Activity of Children (Higher scores mean a better outcome.) | baseline | 
| Scores of activities | Functional Independence Measure for Children (Scores from 18 to 126, higher scores mean a better outcome.) | baseline | 
| Scores of quality of life | Pediatric Quality of Life Inventory TM (Scores from 0 to 102, higher scores mean a better outcome.) | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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language development, gene, whole-exome sequencing, body function and body structure, quality of life