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Clinical Trials/NCT03700190
NCT03700190
Unknown
Not Applicable

Developmental Function and Participation in Life and School Activities in Patients With Autism Spectrum Disorder: A Follow-up Study

Chang Gung Memorial Hospital1 site in 1 country180 target enrollmentAugust 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Chang Gung Memorial Hospital
Enrollment
180
Locations
1
Primary Endpoint
Change from baseline of body function & structures in 6 months and 12 months
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
October 31, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Change from baseline of body function & structures in 6 months and 12 months

Time Frame: baseline, 6 months, 12 months

Bruininks- Oseretsky Test of Motor Proficiency II short form

Change from baseline of Participation in 6 months and 12 months

Time Frame: baseline, 6 months, 12 months

Preferences for Activity of Children(APCP): For children between the ages of two and five, the questionnaire model is used to allow parents to circle the level. There are 45 questions in total, so that the case or parent can review the activities in the past 4 months and ask if the child have done this activity (1 point means yes, 0 points means no).

Change from baseline of Visual Perception in 6 months and 12 months

Time Frame: baseline, 6 months, 12 months

Test of Visual Perceptual Skills-Third Edition

Change from baseline of general developmental for Healthy child and patients with Autism Spectrum Disorder in 6 months and 12 months

Time Frame: baseline, 6 months, 12 months

Comprehensive Developmental Inventory for Infants and Toddlers

Change from baseline of Sensory and Perceptual function in 6 months and 12 months

Time Frame: baseline, 6 months, 12 months

Sensory Profile:It is composed of 125 projects and is completed by the main caregivers of children. There are 14 sub-projects, which can be divided into three main areas: sensory processing (6 items), adjustment (5 items), and emotional response ( 3 items), the project score is divided into 0, 25, 50, 75, 100% (none, rarely, occasionally, often, almost always)

Secondary Outcomes

  • Change from baseline of Quality of Life in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of Personal & Environment factor in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of Social Responsiveness Scale in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of facial expression in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of Clancy Behavior Scale in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of Theory of Mind Inventory-2 in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of Childhood Autism Rating Scale II in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of Rehabilitation & community service factor in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of lower extremity function & structures in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of activities in 6 months and 12 months(baseline, 6 months, 12 months)
  • Change from baseline of Childhood Asperger Syndrome Test in 6 months and 12 months(baseline, 6 months, 12 months)

Study Sites (1)

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