Genetic Biomarkers Associated With Child Language Development in Taiwan

A study of the relation between genetic biomarkers and child language development in Taiwan.

Study Overview

• Status: Recruiting
• Conditions: Child Language

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 596

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Control and experimental groups

Description

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 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control; Healthy child
Experimental; Patients with language disorder

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Ministry of Science and Technology, Taiwan

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2020
• Primary Completion (ANTICIPATED): July 31, 2023
• Study Completion (ANTICIPATED): July 31, 2023

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (ACTUAL): August 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 24, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: gene; language development; quality of Life; whole-exome sequencing; body function and body structure
• Other Study ID Numbers: 201901976A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No