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Genetic Biomarkers Associated With Child Language Development in Taiwan (II)

Genetic Biomarkers Associated With Child Language Development in Taiwan (II)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05510570
Enrollment
115
Registered
2022-08-22
Start date
2021-08-02
Completion date
2022-07-31
Last updated
2024-08-28

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 research does not require interventions

We use Whole-exome sequence (WES) to analyze if there is any gene mutations for DLD(developmental language disorder) children.

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 18 Years

Inclusion criteria

* 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

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.) Applied for children aged 3-71 months. Assessing areas: Cognition, language, motor, social, and self-care skills. Every item is scored 0 or 1, indicating whether the child 'fails' or 'passess' that item.
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/o)baselineChildren 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

Outcome results

None listed

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