Developmental Trajectory of Gene and Life Participation in Children With Developmental Delay

Completed

• Conditions: Genetics; Life Participation

• Registration Number: NCT06674928
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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 every year for five years in total. No intervention will be given during the whole study period.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2024-10
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Agreeing in consent
• In the age range of 6-15 years old

Exclusion Criteria

• Diseases of Central Nervous System
• Diseases of Neuromuscular
• Nature deficit disorder
• Genetic Disorder
• Sensory Integration disorder
• Auditory disorder

Development delay children

Inclusion Criteria:

• Agreeing in consent
• In the age range of 6-15 years old
• Diagnosed of Developmental Delay

Exclusion Criteria:

• Diseases of Central Nervous System
• Diseases of Neuromuscular
• Nature deficit disorder
• Genetic Disorder
• Sensory Integration disorder
• Auditory disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score of participation (< 3y)	baseline	Children Assessment of Participation and Enjoyment and Preferences for Activity of Children (Higher scores means a better outcome.)
Score of participation (3y > 15y)	Baseline	Pediatric Quality of Life Inventory TM (Scores from 0 to 102, higher scores mean a better outcome.)

Secondary Outcome Measures

Name	Time	Method
Gene Test	Baseline	Whole-Exome Sequencing (Use Burrows-Wheeler Aligner (BWA) 85, Samtools86, Picard, Genome Analysis Toolkit (GATK) to screen out the variant discovery and genotyping.)

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan