Clinical trial NCT03700190: The Predictors for Activity and Participation in Children With ASD: A Follow-up Study
Official title: Developmental Function and Participation in Life and School Activities in Patients With Autism Spectrum Disorder: A Follow-up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism Spectrum Disorder
Keywords: autism
activity and participation
sensory perception
facial expression
developmental functions
predictors
follow-up study
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 180
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a prospective and follow-up study. Children with Autism Spectrum Disorder and Typical Developmental, aged 2-18 years.

Brief summary: Developmental function and Participation in life and school activities in patients with autism spectrum disorder: A follow-up study

Detailed description: Most ASD studies have explored the body functions and core symptoms in children with ASD by follow-up, but less studies explore the activities and participation by follow-up, especially the changes in different ages. Although studies explore many predictors to predict the activities and participation in children with ASD, but less studies explore sensory perception to predict the activities and participation in children with ASD.

Eligibility criteria: Inclusion Criteria:

* Patients with Autism Spectrum Disorder
* Age 2-18 y/o
* Agree to sign informed consent

Exclusion Criteria:

* Active medical condition (e.g. infection)
* Concurrent progressive or degenerative disease (e.g. neurogenerative disease)
* Concurrent illness or disease not typically associated with ASD (e.g. pneumonia)

Primary outcomes:
measure: Change from baseline of general developmental for Healthy child and patients with Autism Spectrum Disorder in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of body function & structures in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Sensory and Perceptual function in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Participation in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Participation in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Visual Perception in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
Secondary outcomes:
measure: Change from baseline of lower extremity function & structures in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of activities in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Quality of Life in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Personal & Environment factor in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Rehabilitation & community service factor in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Social Responsiveness Scale in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of facial expression in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Clancy Behavior Scale in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Theory of Mind Inventory-2 in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Childhood Autism Rating Scale II in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of Childhood Asperger Syndrome Test in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ling Chen, MD, PhD
role: STUDY_DIRECTOR
References: