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

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

Study Overview

• Status: Recruiting
• Conditions: Child Language
• Intervention / Treatment: Genetic: The experiment does not required any intervention

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): 300

Contacts and Locations

• Study Contact: Name: Chia-Ling Chen, MD, PhD; Phone Number: 8148 +883-3-3281200; Email: clingchen@gmail.com

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Recruiting
    • Chang Gung Memoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Control and experimetn group

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; healthy child
Experimental group; parents with language disorder	Genetic: The experiment does not required any intervention; The experiment does not required any intervention

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 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
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

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 2, 2022
• Primary Completion (ANTICIPATED): July 31, 2025
• Study Completion (ANTICIPATED): July 31, 2025

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (ACTUAL): August 17, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; gene; language development; whole-exome sequencing; body function and body structure
• Other Study ID Numbers: 202102436A3

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