Child LanguageNCT04518787
Genetic Biomarkers Associated With Child Language Development in Taiwan
An observational study of Child Language, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
A study of the relation between genetic biomarkers and child language development in Taiwan. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Language
- How many people
- 596 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Aug 2020to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Control and experimental groups
Who may be able to join
- Age 2-18 y/o
- Agree to sign informed consent
- Patients with Language Disorder
- Age 2-18 y/o
- Agree to sign informed consent
- His or her child participated in this study, and gene abnormality was found.
Who cannot join
- Central nervous system disease
- Neuromuscular Disorders
- Congenital Abnormality
- Genetic Disease
- Dysesthesia
- Hearing Impairment
- Hearing Impairment
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Chia-Ling Chen, MD, PhD, +886-3-3281200 ext. 8148, clingchen@gmail.com
About this study
A study of the relation between genetic biomarkers and child language development in Taiwan.
Read the 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.
- Conditions
- Child Language
- Keywords
- language development, gene, whole-exome sequencing, body function and body structure, quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy child | |
| Experimental | Patients with language disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores of cognitive function 1
Bayley Scales of Infant and Toddler Development (Scores from 0 to 140, higher scores mean a better outcome.)
Measured: 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.)
Measured: 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.)
Measured: baseline
Scores of cognitive function 3
Test of Nonverbal Intelligence-Fourth Edition (Scores from 0 to 60, higher scores mean a better outcome.)
Measured: baseline
Scores of language function 1
Peabody Picture Vocabulary Test-Revised (Scores from 0 to 124, higher scores mean a better outcome.)
Measured: 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.)
Measured: baseline
Scores of general development
Comprehensive Developmental Inventory for Infants and Toddlers (Higher scores mean a better outcome.)
Measured: baseline
Gene test 1
Microarray (Use Axiom Genome-Wide TWB 2.0 Array Plate (TWB 2.0) to analyze SNPs of disease-related biomarkers.)
Measured: 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.)
Measured: baseline
Secondary outcomes (4)
Scores of participation(2-5 y/o)
Assessment of Preschool Children's Participation (Scores from 0 to 45, higher scores mean a better outcome.)
Measured: baseline
Scores of participation(>6 y/o)
Children Assessment of Participation and Enjoyment and Preferences for Activity of Children (Higher scores mean a better outcome.)
Measured: baseline
Scores of activities
Functional Independence Measure for Children (Scores from 18 to 126, higher scores mean a better outcome.)
Measured: baseline
Scores of quality of life
Pediatric Quality of Life Inventory TM (Scores from 0 to 102, higher scores mean a better outcome.)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start20 Aug 2020
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child LanguageStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 596 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, MD, PhD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518787
- Sponsor's protocol ID
- 201901976A3
- Status last verified
- Oct 2021
- First submitted
- 17 Aug 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Biomarkers Associated With Child Language Development in Taiwan
- ClinicalTrials.gov ID
- NCT04518787
- Acronym / sponsor ID
- 201901976A3
- Conditions
- Child Language
- Keywords
- language development, gene, whole-exome sequencing, body function and body structure, quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 596 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Healthy child |
| Experimental | – | –Patients with language disorder |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Control and experimental groups
Key inclusion criteria (6 listed)
- Age 2-18 y/o
- Agree to sign informed consent
- Patients with Language Disorder
- Age 2-18 y/o
- Agree to sign informed consent
Key exclusion criteria (7 listed)
- Central nervous system disease
- Neuromuscular Disorders
- Congenital Abnormality
- Genetic Disease
- Dysesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.)
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.)
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.)
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.)
Scores of language function 1
Time frame: baseline
Peabody Picture Vocabulary Test-Revised (Scores from 0 to 124, higher scores mean a better outcome.)
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.)
Scores of general development
Time frame: baseline
Comprehensive Developmental Inventory for Infants and Toddlers (Higher scores mean a better outcome.)
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.)
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.)
4 secondary outcomes
Scores of participation(2-5 y/o)
Time frame: baseline
Scores of participation(>6 y/o)
Time frame: baseline
Scores of activities
Time frame: baseline
Scores of quality of life
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Ling Chen, MD, PhD study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Language, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Ling Chen, MD, PhD (+886-3-3281200 ext. 8148, clingchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores of cognitive function 1 (time frame: baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.