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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 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| developmental disabilities group | this group recruited children with developmental disabilities | ||
| typical developmental group | This regoup recruited children with typical development |
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| Measure | Description | Time Frame |
|---|---|---|
| Wechsler Preschool and Primary Scale of Intelligence | Assess participant's intelligence. Verbal Comprehension Index:
Visual Spatial Index:
Fluid Reasoning Index:
Working Memory Index:
| initial assessment |
| Test of Nonverbal Intelligence-Fourth Edition | assess participant's intelligence. | initial assessment |
| Cantab | Assess participant's cognitive function Motor Screening Task:
Paired Associates Learning:
Spatial Working Memory:
Rapid Visual Information Processing:
| initial assessment |
| Peabody Picture Vocabulary Test-Revised | Assess participant's language function. |
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Inclusion Criteria:
Exclusion Criteria:
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475 participants with developmental disabilities and 50 healthy participants
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chia-Ling Chen, MDPhD | Contact | 88633281200 | 8148 | chialingchen@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| ChiaLing Chen | Chang Gung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Recruiting | Taoyuan | 241 | Taiwan |
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| ID | Term |
|---|---|
| D002658 | Developmental Disabilities |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 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. | initial assessment |
| Swanson, Nolan, and Pelham, version IV | screen ADHD symptoms. | initial assessment |
| The Berry-Buktenica Developmental Test of Visual-Motor Integration | Assess participant's motor function. | initial assessment |
| Comprehensive Developmental Inventory for Infants and Toddlers | Assess participant's general development. | initial assessment |
| Functional Independence Measure for Children | Assess functional abilities of children and adolescents The WeeFIM includes three primary domains:
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. | initial assessment |
| Assessment of Preschool Children's Participation | Assess participant's participation in every day tasks. | 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. | initial assessment |
| PedsQL TM | Assess participant's quality of life. Core Scales:
The PedsQl uses a 5-point likert scale for responses. Higher score indicate better health-related quality of life. | initial assessment |