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

NCT06674928 | Completed DMC

• 1 other identifier: 202301017A3
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Genetics; Life Participation

Keywords

Developmental delay; Life participation; Quality of life; Whole-exome sequencing; Gene; Children Development

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Gene Test

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Control and experimental group

You may qualify if:

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

You may not qualify if:

• Diseases of Central Nervous System
• Diseases of Neuromuscular
• Nature deficit disorder
• Genetic Disorder
• Sensory Integration disorder
• Auditory disorder
• Development delay children
• Agreeing in consent
• In the age range of 6-15 years old
• Diagnosed of Developmental Delay
• Diseases of Central Nervous System
• Diseases of Neuromuscular
• Nature deficit disorder
• Genetic Disorder
• Sensory Integration disorder

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Chia-Ling Chen, MD,PhD

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: July 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: November 20, 2025

Record last verified: 2024-10

Locations

TW (1)