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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05504564
Enrollment
300
Registered
2022-08-17
Start date
2022-08-02
Completion date
2025-07-31
Last updated
2022-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Language

Keywords

language development, gene, whole-exome sequencing, body function and body structure, quality of life

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.

Interventions

GENETICThe experiment does not required any intervention

The experiment does not required any intervention

Sponsors

Ministry of Science and Technology, Taiwan
CollaboratorOTHER_GOV
Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
Yes

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 *

Design outcomes

Primary

MeasureTime frameDescription
Gene test 2baselineWhole-Exome Sequencing (Use Burrows-Wheeler Aligner (BWA) 85, Samtools86, Picard, Genome Analysis Toolkit (GATK) to screen out the variant discovery and genotyping.)
Scores of language function 1baselinePeabody Picture Vocabulary Test-Revised (Scores from 0 to 124, higher scores mean a better outcome.)
Scores of language function 2baselinePreschool 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 developmentbaselineComprehensive Developmental Inventory for Infants and Toddlers (Higher scores mean a better outcome.)
Gene test 1baselineMicroarray (Use Axiom Genome-Wide TWB 2.0 Array Plate (TWB 2.0) to analyze SNPs of disease-related biomarkers.)
Scores of cognitive function 1baselineBayley Scales of Infant and Toddler Development (Scores from 0 to 140, higher scores mean a better outcome.)
Scores of cognitive function (2 y/o to 6 y/o)baselineWechsler 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)baselineWechsler Intelligence Scale for Children (Scores from 0 to 200, higher scores mean a better outcome.)
Scores of cognitive function 3baselineTest of Nonverbal Intelligence-Fourth Edition (Scores from 0 to 60, higher scores mean a better outcome.)

Secondary

MeasureTime frameDescription
Scores of participation(>6 y/obaselineChildren Assessment of Participation and Enjoyment and Preferences for Activity of Children (Higher scores mean a better outcome.)
Scores of activitiesbaselineFunctional Independence Measure for Children (Scores from 18 to 126, higher scores mean a better outcome.)
Scores of quality of lifebaselinePediatric Quality of Life Inventory TM (Scores from 0 to 102, higher scores mean a better outcome.)
Scores of participation(2-5 y/o)baselineAssessment of Preschool Children's Participation (Scores from 0 to 45, higher scores mean a better outcome.)

Countries

Taiwan

Contacts

Primary ContactChia-Ling Chen, MD, PhD
clingchen@gmail.com+883-3-3281200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026