GeneticsNCT06674928
Developmental Trajectory of Gene and Life Participation in Children With Developmental Delay
An observational study of Genetics and Life Participation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The goal of this observational study is to learn the factors affecting the quality of life in children's development. The main hypothesis for this study is: If the level of well-being increases in age, could the quality of life be enhanced in terms of function and participation? Participant will be given assessment… Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Genetics, Life Participation
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2024to 31 Oct 2024
- How long will I take part?
- 1 Year
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Control and experimental group
Who may be able to join
- Agreeing in consent
- In the age range of 6-15 years old
- Agreeing in consent
- In the age range of 6-15 years old
- Diagnosed of Developmental Delay
Who cannot join
- Diseases of Central Nervous System
- Diseases of Neuromuscular
- Nature deficit disorder
- Genetic Disorder
- Sensory Integration disorder
- Auditory disorder
Show all 13Show fewer
- Development delay children
- Diseases of Central Nervous System
- Diseases of Neuromuscular
- Nature deficit disorder
- Genetic Disorder
- Sensory Integration disorder
- Auditory disorder
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to learn the factors affecting the quality of life in children's development.
The main hypothesis for this study is:
If the level of well-being increases in age, could the quality of life be enhanced in terms of function and participation?
Participant will be given assessment every year for five years in total. No intervention will be given during the whole study period.
- Conditions
- Genetics, Life Participation
- Keywords
- Developmental delay, Life participation, Quality of life, Whole-exome sequencing, Gene, Children Development
- Medical subject headings
- Learning Disabilities
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 |
|---|---|---|
| Normal Developing Children | Children that were satisfied with the criteria as average or "on-time" growth based on the attainment of specific physical, cognitive, linguistic, social-emotional, and behavioral milestones across specific stages. | |
| Developmental Delay Children | Children who has not gained the developmental skills expected of him or her, compared to others of the same age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of participation (< 3y)
Children Assessment of Participation and Enjoyment and Preferences for Activity of Children (Higher scores means a better outcome.)
Measured: baseline
Score of participation (3y > 15y)
Pediatric Quality of Life Inventory TM (Scores from 0 to 102, higher scores mean a better outcome.)
Measured: Baseline
Secondary outcomes (1)
Gene Test
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Jul 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeneticsStudies 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
- 500 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, MD,PhD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674928
- Sponsor's protocol ID
- 202301017A3
- Status last verified
- Oct 2024
- First submitted
- 4 Nov 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Trajectory of Gene and Life Participation in Children With Developmental Delay
- ClinicalTrials.gov ID
- NCT06674928
- Acronym / sponsor ID
- 202301017A3
- Conditions
- Genetics, Life Participation
- Keywords
- Developmental delay, Life participation, Quality of life, Whole-exome sequencing, Gene, Children Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 5 Nov 2024 (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.
The goal of this observational study is to learn the factors affecting the quality of life in children's development.
The main hypothesis for this study is:
If the level of well-being increases in age, could the quality of life be enhanced in terms of function and participation?
Participant will be given assessment every year for five years in total. No intervention will be given during the whole study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Developing Children | – | –Children that were satisfied with the criteria as average or "on-time" growth based on the attainment of specific physical, cognitive, linguistic, social-emotional, and behavioral milestones across specific stages. |
| Developmental Delay Children | – | –Children who has not gained the developmental skills expected of him or her, compared to others of the same age. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Control and experimental group
Key inclusion criteria (5 listed)
- Agreeing in consent
- In the age range of 6-15 years old
- Agreeing in consent
- In the age range of 6-15 years old
- Diagnosed of Developmental Delay
Key exclusion criteria (13 listed)
- Diseases of Central Nervous System
- Diseases of Neuromuscular
- Nature deficit disorder
- Genetic Disorder
- Sensory Integration disorder
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
Score of participation (< 3y)
Time frame: baseline
Children Assessment of Participation and Enjoyment and Preferences for Activity of Children (Higher scores means a better outcome.)
Score of participation (3y > 15y)
Time frame: Baseline
Pediatric Quality of Life Inventory TM (Scores from 0 to 102, higher scores mean a better outcome.)
1 secondary outcome
Gene Test
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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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 Genetics and Life Participation, 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 20 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of participation (< 3y) (time frame: baseline). The study lists 2 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 20 Nov 2025.