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.

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Key information

Conditions

Genetics Communication Disorders Learning Disabilities Life Participation Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.)

Secondary outcomes

Gene Test

Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Nov 5, 2024
Registry last updated: Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed