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

Recruiting

• Conditions: Child Language
• Interventions: Genetic: The experiment does not required any intervention

• Registration Number: NCT05504564
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2022-08
• Study Start: 2022-08-02
• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-16
• Last Update Submitted: 2022-08-16
• Study First Posted: 2022-08-17
• Last Update Posted: 2022-08-17
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental group	The experiment does not required any intervention	parents with language disorder

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chang Gung Memoria Hospital; 🇨🇳 Taoyuan, Taiwan