NCT05504564

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

August 16, 2022

Last Update Submit

August 16, 2022

Conditions

Child Language

Keywords

language developmentgenewhole-exome sequencingbody function and body structurequality of life

Outcome Measures

Primary Outcomes (9)

  • Scores of cognitive function 1

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

    baseline

  • 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

  • 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

  • Scores of cognitive function 3

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

    baseline

  • Scores of language function 1

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

    baseline

  • 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

  • Scores of general development

    Comprehensive Developmental Inventory for Infants and Toddlers (Higher scores mean a better outcome.)

    baseline

  • Gene test 1

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

    baseline

  • 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 Outcomes (4)

  • Scores of participation(2-5 y/o)

    baseline

  • Scores of participation(>6 y/o

    baseline

  • Scores of activities

    baseline

  • Scores of quality of life

    baseline

Study Arms (2)

Control group

healthy child

Experimental group

parents with language disorder

Genetic: The experiment does not required any intervention

Interventions

The experiment does not required any interventionGENETIC

The experiment does not required any intervention

Experimental group

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Control and experimetn group

You may qualify if:

  • Age 2-18 y/o
  • Agree to sign informed consent

You may not qualify if:

  • Central nervous system disease
  • Neuromuscular Disorders
  • Congenital Abnormality
  • Genetic Disease
  • Dysesthesia
  • Hearing Impairment
  • Patients with Language Disorder
  • Age 2-18 y/o
  • Agree to sign informed consent
  • Hearing Impairment
  • His or her child participated in this study, and gene abnormality was found.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memoria Hospital

Taoyuan District, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA

Study Officials

  • Chia-Ling Chen, MD, PhD

    Chang Gung Memorial Hospital

    STUDY DIRECTOR

Central Study Contacts

Chia-Ling Chen, MD, PhD

CONTACT

+883-3-3281200clingchen@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 17, 2022

Study Start

August 2, 2022

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

August 17, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)