Child Development and Genetic Biomarkers

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

Official Title
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Child Development and Genetic Biomarkers

Conditions
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Child Development

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria of Healthy Child: Age 2-18 y/o Agree to sign informed consent Exclusion Criteria of Healthy Child: Central nervous system disease Neuromuscular Disorders Congenital Abnormality Genetic Disease Dysesthesia Hearing Impairment Inclusion Criteria of Child with developmental delay: Patients with Language Disorder Age 2-18 y/o Agree to sign informed consent Exclusion Criteria of Child with developmental delay: 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: 1 Year
Maximum Age: 18 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<br>Healthy child | |
| Experimental<br>Patients with developmental delay | |

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 cognitive psychological function | Cantab MOT, PAL, SWM, SOC tests | baseline | 
| Scores of language function | 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 | 
| Scores of social behavior 1 | Clancy Behavior Scale (Scores from 0 to 42, lower scores mean a better outcome.) | baseline | 
| Scores of social behavior 2 | Swanson, Nolan, and Pelham, Version IV (Lower scores mean a better outcome.) | baseline | 
| Scores of motor ability 1 | The Berry-Buktenica Developmental Test of Visual-Motor Integration (Scores from 0 to 81, Higher scores mean a better outcome.) | baseline | 
| Scores of motor ability 2 | Measure of Grip and Grasp (Higher scores mean a better outcome.) | baseline | 
| Gene test (Mircoarray) | Microarray (Use Axiom Genome-Wide TWB 2.0 Array Plate (TWB 2.0) to analyze SNPs of disease-related biomarkers.) | baseline | 
| Gene test (WES1) | Whole-Exome Sequencing (Use Burrows-Wheeler Aligner (BWA) 85 to screen out the variant discovery and genotyping.) | baseline | 
| Gene test (WES2) | Whole-Exome Sequencing (Use Samtools86 to screen out the variant discovery and genotyping.) | baseline | 
| Gene test (WES3) | Whole-Exome Sequencing (Use Picard to screen out the variant discovery and genotyping.) | baseline | 
| Gene test (WES4) | Whole-Exome Sequencing (Use 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 |