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

Child Language Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05504564
• Other study ID #: 202102436A3
• Status: Recruiting
• Start date: August 2, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: August 2022
• Source: Chang Gung Memorial Hospital
• Contact: Chia-Ling Chen, MD, PhD
• Phone: +883-3-3281200
• Email: clingchen[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Language

Intervention

Genetic:
• The experiment does not required any intervention
The experiment does not required any intervention

Locations

Country	Name	City	State
Taiwan	Chang Gung Memoria Hospital	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores of cognitive function 1	Bayley Scales of Infant and Toddler Development (Scores from 0 to 140, higher scores mean a better outcome.)	baseline
Primary	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
Primary	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
Primary	Scores of cognitive function 3	Test of Nonverbal Intelligence-Fourth Edition (Scores from 0 to 60, higher scores mean a better outcome.)	baseline
Primary	Scores of language function 1	Peabody Picture Vocabulary Test-Revised (Scores from 0 to 124, higher scores mean a better outcome.)	baseline
Primary	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
Primary	Scores of general development	Comprehensive Developmental Inventory for Infants and Toddlers (Higher scores mean a better outcome.)	baseline
Primary	Gene test 1	Microarray (Use Axiom Genome-Wide TWB 2.0 Array Plate (TWB 2.0) to analyze SNPs of disease-related biomarkers.)	baseline
Primary	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	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
Secondary	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
Secondary	Scores of activities	Functional Independence Measure for Children (Scores from 18 to 126, higher scores mean a better outcome.)	baseline
Secondary	Scores of quality of life	Pediatric Quality of Life Inventory TM (Scores from 0 to 102, higher scores mean a better outcome.)	baseline