Developmental DisabilitiesNCT06532721
Child Development and Genetic Biomarkers(II): Gene Verification and Data Integration
An observational study of Developmental Disabilities, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The aims of the study include (1) identifying genes associated with child development and developmental delay in Taiwan (2) comparing the differences and similarities between genetic biomarkers of development and developmental delay for children in Taiwan and children from other countries (3) employing precision… Read more about this study
- Who is it for?
- Ages Up to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Disabilities
- How many people
- 525 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2022to 30 Nov 2025
- How long will I take part?
- 1 Day
- 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 Up to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 475 participants with developmental disabilities and 50 healthy participants
Who may be able to join
- Consent signing
- 0-40 years old
- Typical development or developmental disabilities
Who cannot join
- Central Nervous disease
- Neuromuscular disease
- Congenital disease
- Sensory disorder such as blindness or hearing impairment
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 241
ChiaLing Chen, 88633281200 ext. 8148, chialingchen@gmail.com
About this study
The aims of the study include (1) identifying genes associated with child development and developmental delay in Taiwan (2) comparing the differences and similarities between genetic biomarkers of development and developmental delay for children in Taiwan and children from other countries (3) employing precision medicine as the method for genetic screening or test and (4) tracking children's biological, psychological and social adjustment, especially for those who have early-onset developmental delay.
Read the detailed description
The aims of the study include (1) identifying genes associated with child development and developmental delay in Taiwan (2) comparing the differences and similarities between genetic biomarkers of development and developmental delay for children in Taiwan and children from other countries (3) employing precision medicine as the method for genetic screening or test and (4) tracking children's biological, psychological and social adjustment, especially for those who have early-onset developmental delay.
The study will be completed in two phases over three years and will enroll a total of 475 0~40-year-old participants. In the first phase, we will recruit 380 participants. Including 50 participants with typical development, 300 participants with developmental delay and 30 parents to whom have children with severe DD. Then, their genetic data will be compared with genetic data of Chang Gung Hospital and the National Center for Genome Medicine, expect to preliminary find genes associated with child language development. At the same time, 20-30 children with severe developmental delay or have family history of developmental delay will be selected as a pilot study, using whole-exome sequencing (WES) to find other genes associated with development. If the gene deficiency was found in the children, we will invite his or her parents to do WES. In the second phase, we will establish a gene panel according to the genes identified in the previous stage and recruit 95 children with developmental delay to test the gene panel prospectively. The long-term goal of this study is to establish a pioneer study for children
- Conditions
- Developmental Disabilities
- Medical subject headings
- Developmental 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 |
|---|---|---|
| developmental disabilities group | this group recruited children with developmental disabilities | |
| typical developmental group | This regoup recruited children with typical development |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wechsler Preschool and Primary Scale of Intelligence
Assess participant's intelligence.
Verbal Comprehension Index:
- Minimum Value :50
- Maximum Value : 150
- Interpretation : Higher score indicate better verbal reasoning, concept formation, and verbal comprehension abilities.
Visual Spatial Index:
- Minimum Value :50
- Maximum Value : 150
- Interpretation : Higher score indicate better visual-spatial reasoning and problem solving skills.
Fluid Reasoning Index:
- Minimum Value :50
- Maximum Value : 150
- Interpretation : Higher score indicate stronger abilities in abstract reasoning and problem solving skills.
Working Memory Index:
- Minimum Value :50
- Maximum Value : 150
- Interpretation : Higher score indicate better working memory, whic
Measured: initial assessment
Test of Nonverbal Intelligence-Fourth Edition
assess participant's intelligence.
Measured: initial assessment
Cantab
Assess participant's cognitive function
Motor Screening Task:
- Assess basic motor control and response to visual stimuli.
- Measurement: Reaction time and movement time.
- Faster response times indicate better motor function. Slower time suggest motor impairments or difficulties in visual processing.
Paired Associates Learning:
- Tests visual memory and new learning.
- Measurement: Number of errors made during the task.
- Higher error rated indicate poorer memory performance. Lower error rates suggest better visual memory and associative learning.
Spatial Working Memory:
- Assess the ability to retain and manipulate spatial information
- Measurement: Number of errors and strategy scores.
- Fewer errors and better strategy scores indicate better spatial working memory.
Rapid Visual Information Processing:
- Evaluates sustained attention and vigilance.
- Measurements: Detection targets sequences within rapidly presented digits.
- Higher hit rates and lower false
Measured: initial assessment
Peabody Picture Vocabulary Test-Revised
Assess participant's language function.
Measured: initial assessment
Clancy Behavior Scale
Help identifying autism symptoms.
The scale covers multiple behavioral domains such as aggression, anxiety, social skills, attention and hyperactivity.
The scale is administered as a questionnaire where parents, or caregivers rate the frequency and intensity of specific behaviors shown by the children. Responses are given on a Likert scale of 3.
Minimum value: The scale's scoring system ranges from 0 (indicating no problematic behavior) to higher value of 2, depending on the number of items and the severity of the behavior assessed.
Maximum value: The upper end of the scale is determined by the total number of items and the scoring format.
Higher scores typically indicate more frequent or severe behavioral issues, while lower scores suggest fewer or less sever issues.
Measured: initial assessment
Swanson, Nolan, and Pelham, version IV
screen ADHD symptoms.
Measured: initial assessment
The Berry-Buktenica Developmental Test of Visual-Motor Integration
Assess participant's motor function.
Measured: initial assessment
Comprehensive Developmental Inventory for Infants and Toddlers
Assess participant's general development.
Measured: initial assessment
Functional Independence Measure for Children
Assess functional abilities of children and adolescents
The WeeFIM includes three primary domains:
- Self-care: Assesses the ability to perform basic self-care tasks independently.
- Mobility: Measures the ability to move from one place to another and perform transfer.
- Cognition: Evaluates cognitive abilities related to communication, social skills, and problem-solving.
Rating scale: Each of the 18 items is rated on a 7-point scale based on the level of independence.
Minimum Score: 18 (indicating complete dependence across all items) Maximum Score: 126 (indicating complete independence across all items)
Higher score indicate greater functional independence, meaning the child requires less assistance to perform daily activities.
Lower score indicate greater dependence, suggesting the child requires more assistance or is unable to perform certain tasks independently.
Measured: initial assessment
Assessment of Preschool Children's Participation
Assess participant's participation in every day tasks.
Measured: initial assessment
Children Assessment of Participation and Enjoyment and Preferences for Activity of Children
Assess participant's participation in every day tasks.
The CAPE and PAC are designed for children and adolescents aged 6 to 21 years.
Both tools are typically administered through structured questionnaires or interviews, either in paper form or electronically.
CAPE: Helps identify areas where a child may be under-participating, guiding interventions to encourage greater engagement in a wider variety of activities.
PAC: Provides insight into activities the child is interested in but may not currently participate in, helping to tailor activities to their preferences.
Scoring:
CAPE: Higher diversity and intensity scores indicate more varied and frequent participation. Higher enjoyment scores indicate greater pleasure derived from activities.
PAC: Higher scores indicate a stronger preference for specific activities.
Measured: initial assessment
PedsQL TM
Assess participant's quality of life.
Core Scales:
- Physical Functioning: Assesses difficulties with physical activities, such as walking, running, and participating in sports.
- Emotional Functioning: Evaluates feelings of sadness, worry, and anger, as well as overall emotional well-being.
- Social Functioning: Measures interactions with peers, the ability to make friends, and feelings or being excluded or bullied.
- School Functioning: Assesses difficulties in paying attention in class, missing school due to illness, and keeping up with schoolwork.
The PedsQl uses a 5-point likert scale for responses.
Higher score indicate better health-related quality of life.
Measured: initial assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Dec 2022
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DisabilitiesStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 525 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ChiaLing Chen, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532721
- Sponsor's protocol ID
- GENE-CGMH 2023 (DD)
- Status last verified
- May 2024
- First submitted
- 30 Jul 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Child Development and Genetic Biomarkers(II): Gene Verification and Data Integration
- ClinicalTrials.gov ID
- NCT06532721
- Acronym / sponsor ID
- GENE-CGMH 2023 (DD)
- Conditions
- Developmental Disabilities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 1 Aug 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 aims of the study include (1) identifying genes associated with child development and developmental delay in Taiwan (2) comparing the differences and similarities between genetic biomarkers of development and developmental delay for children in Taiwan and children from other countries (3) employing precision medicine as the method for genetic screening or test and (4) tracking children's biological, psychological and social adjustment, especially for those who have early-onset developmental delay.
Detailed description
The aims of the study include (1) identifying genes associated with child development and developmental delay in Taiwan (2) comparing the differences and similarities between genetic biomarkers of development and developmental delay for children in Taiwan and children from other countries (3) employing precision medicine as the method for genetic screening or test and (4) tracking children's biological, psychological and social adjustment, especially for those who have early-onset developmental delay.
The study will be completed in two phases over three years and will enroll a total of 475 0~40-year-old participants. In the first phase, we will recruit 380 participants. Including 50 participants with typical development, 300 participants with developmental delay and 30 parents to whom have children with severe DD. Then, their genetic data will be compared with genetic data of Chang Gung Hospital and the National Center for Genome Medicine, expect to preliminary find genes associated with child language development. At the same time, 20-30 children with severe developmental delay or have family history of developmental delay will be selected as a pilot study, using whole-exome sequencing (WES) to find other genes associated with development. If the gene deficiency was found in the children, we will invite his or her parents to do WES. In the second phase, we will establish a gene panel according to the genes identified in the previous stage and recruit 95 children with developmental delay to test the gene panel prospectively. The long-term goal of this study is to establish a pioneer study for children
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| developmental disabilities group | – | –this group recruited children with developmental disabilities |
| typical developmental group | – | –This regoup recruited children with typical development |
Who may qualify
- Ages
- Up to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 475 participants with developmental disabilities and 50 healthy participants
Key inclusion criteria (3 listed)
- Consent signing
- 0-40 years old
- Typical development or developmental disabilities
Key exclusion criteria (4 listed)
- Central Nervous disease
- Neuromuscular disease
- Congenital disease
- Sensory disorder such as blindness or hearing impairment
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
Wechsler Preschool and Primary Scale of Intelligence
Time frame: initial assessment
Assess participant's intelligence. Verbal Comprehension Index: * Minimum Value :50 * Maximum Value : 150 * Interpretation : Higher score indicate better verbal reasoning, concept formation, and verbal comprehension abilities. Visual Spatial Index: * Minimum Value :50 * Maximum Value : 150 * Interpretation : Higher score indicate better visual-spatial reasoning and problem solving skills. Fluid Reasoning Index: * Minimum Value :50 * Maximum Value : 150 * Interpretation : Higher score indicate stronger abilities in abstract reasoning and problem solving skills. Working Memory Index: * Minimum Value :50 * Maximum Value : 150 * Interpretation : Higher score indicate better working memory, whic
Test of Nonverbal Intelligence-Fourth Edition
Time frame: initial assessment
assess participant's intelligence.
Cantab
Time frame: initial assessment
Assess participant's cognitive function Motor Screening Task: * Assess basic motor control and response to visual stimuli. * Measurement: Reaction time and movement time. * Faster response times indicate better motor function. Slower time suggest motor impairments or difficulties in visual processing. Paired Associates Learning: * Tests visual memory and new learning. * Measurement: Number of errors made during the task. * Higher error rated indicate poorer memory performance. Lower error rates suggest better visual memory and associative learning. Spatial Working Memory: * Assess the ability to retain and manipulate spatial information * Measurement: Number of errors and strategy scores. * Fewer errors and better strategy scores indicate better spatial working memory. Rapid Visual Information Processing: * Evaluates sustained attention and vigilance. * Measurements: Detection targets sequences within rapidly presented digits. * Higher hit rates and lower false
Peabody Picture Vocabulary Test-Revised
Time frame: initial assessment
Assess participant's language function.
Clancy Behavior Scale
Time frame: initial assessment
Help identifying autism symptoms. The scale covers multiple behavioral domains such as aggression, anxiety, social skills, attention and hyperactivity. The scale is administered as a questionnaire where parents, or caregivers rate the frequency and intensity of specific behaviors shown by the children. Responses are given on a Likert scale of 3. Minimum value: The scale's scoring system ranges from 0 (indicating no problematic behavior) to higher value of 2, depending on the number of items and the severity of the behavior assessed. Maximum value: The upper end of the scale is determined by the total number of items and the scoring format. Higher scores typically indicate more frequent or severe behavioral issues, while lower scores suggest fewer or less sever issues.
Swanson, Nolan, and Pelham, version IV
Time frame: initial assessment
screen ADHD symptoms.
The Berry-Buktenica Developmental Test of Visual-Motor Integration
Time frame: initial assessment
Assess participant's motor function.
Comprehensive Developmental Inventory for Infants and Toddlers
Time frame: initial assessment
Assess participant's general development.
Functional Independence Measure for Children
Time frame: initial assessment
Assess functional abilities of children and adolescents The WeeFIM includes three primary domains: * Self-care: Assesses the ability to perform basic self-care tasks independently. * Mobility: Measures the ability to move from one place to another and perform transfer. * Cognition: Evaluates cognitive abilities related to communication, social skills, and problem-solving. Rating scale: Each of the 18 items is rated on a 7-point scale based on the level of independence. Minimum Score: 18 (indicating complete dependence across all items) Maximum Score: 126 (indicating complete independence across all items) Higher score indicate greater functional independence, meaning the child requires less assistance to perform daily activities. Lower score indicate greater dependence, suggesting the child requires more assistance or is unable to perform certain tasks independently.
Assessment of Preschool Children's Participation
Time frame: initial assessment
Assess participant's participation in every day tasks.
Children Assessment of Participation and Enjoyment and Preferences for Activity of Children
Time frame: initial assessment
Assess participant's participation in every day tasks. The CAPE and PAC are designed for children and adolescents aged 6 to 21 years. Both tools are typically administered through structured questionnaires or interviews, either in paper form or electronically. CAPE: Helps identify areas where a child may be under-participating, guiding interventions to encourage greater engagement in a wider variety of activities. PAC: Provides insight into activities the child is interested in but may not currently participate in, helping to tailor activities to their preferences. Scoring: CAPE: Higher diversity and intensity scores indicate more varied and frequent participation. Higher enjoyment scores indicate greater pleasure derived from activities. PAC: Higher scores indicate a stronger preference for specific activities.
PedsQL TM
Time frame: initial assessment
Assess participant's quality of life. Core Scales: * Physical Functioning: Assesses difficulties with physical activities, such as walking, running, and participating in sports. * Emotional Functioning: Evaluates feelings of sadness, worry, and anger, as well as overall emotional well-being. * Social Functioning: Measures interactions with peers, the ability to make friends, and feelings or being excluded or bullied. * School Functioning: Assesses difficulties in paying attention in class, missing school due to illness, and keeping up with schoolwork. The PedsQl uses a 5-point likert scale for responses. Higher score indicate better health-related quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- 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.
ChiaLing Chen principal investigator
Chang Gung University
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 Developmental Disabilities, 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 3 inclusion and 4 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 29 Aug 2024. 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, MDPhD (88633281200 ext. 8148, chialingchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wechsler Preschool and Primary Scale of Intelligence (time frame: initial assessment). The study lists 12 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 29 Aug 2024.