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

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 Overview

• Status: Completed
• Conditions: Genetics; Life Participation

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan District, Taiwan, 333
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Control and experimental group

Description

Normal developing children

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	Baseline

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Director: Chia-Ling Chen, MD,PhD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Developmental delay; Whole-exome sequencing; Gene; Life participation; Children Development
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Learning Disabilities
• Other Study ID Numbers: 202301017A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No