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Completed

NCT Number: NCT05510570

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

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

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Key information

Conditions

Child Language

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memoria Hospital

Taoyuan, Taiwan

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

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.

Treatment and study plan

The research does not require interventions

Genetic

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

Primary outcomes

  1. Scores of cognitive function 1

    Time frame: baseline

    Bayley Scales of Infant and Toddler Development (Scores from 0 to 140, higher scores mean a better outcome.)

  2. Scores of cognitive function (2 y/o to 6 y/o)

    Time frame: baseline

    Wechsler Preschool and Primary Scale of Intelligence (Scores from 0 to 200, higher scores mean a better outcome.)

  3. Scores of cognitive function (6 y/o to 16 y/o)

    Time frame: baseline

    Wechsler Intelligence Scale for Children (Scores from 0 to 200, higher scores mean a better outcome.)

  4. Scores of cognitive function 3

    Time frame: baseline

    Test of Nonverbal Intelligence-Fourth Edition (Scores from 0 to 60, higher scores mean a better outcome.)

  5. Scores of language function 1

    Time frame: baseline

    Peabody Picture Vocabulary Test-Revised (Scores from 0 to 124, higher scores mean a better outcome.)

  6. Scores of language function 2

    Time frame: 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.)

  7. Scores of general development

    Time frame: baseline

    Comprehensive 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.

  8. Gene test 1

    Time frame: baseline

    Microarray (Use Axiom Genome-Wide TWB 2.0 Array Plate (TWB 2.0) to analyze SNPs of disease-related biomarkers.)

  9. Gene test 2

    Time frame: 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 outcomes

  1. Scores of participation(2-5 y/o)

    Time frame: baseline

    Assessment of Preschool Children's Participation (Scores from 0 to 45, higher scores mean a better outcome.)

  2. Scores of participation(>6 y/o)

    Time frame: baseline

    Children Assessment of Participation and Enjoyment and Preferences for Activity of Children (Higher scores mean a better outcome.)

  3. Scores of activities

    Time frame: baseline

    Functional Independence Measure for Children (Scores from 18 to 126, higher scores mean a better outcome.)

  4. Scores of quality of life

    Time frame: baseline

    Pediatric Quality of Life Inventory TM (Scores from 0 to 102, higher scores mean a better outcome.)

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Ministry of Science and Technology, Taiwan

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 22, 2022
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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