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Status unknownNCT03700190Updated Feb 18, 2022

The Predictors for Activity and Participation in Children With ASD: A Follow-up Study

An observational study in Autism Spectrum Disorder, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 2 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-18.

Sponsored by Chang Gung Memorial Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
2 Years to 18 Years
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Autism Spectrum Disorder

Keywords

  • autism
  • activity and participation
  • sensory perception
  • facial expression
  • developmental functions
  • predictors
  • follow-up study
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In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's planned enrollment of 180 is above the median of 102 across 267 observational studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

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

Exclusion criteria

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (estimated)
Patient registry
No

Groups and cohorts

  • Control

    Healthy child

  • Experimental

    Patients with Autism Spectrum Disorder

06

What researchers measure

Primary outcomes

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

    Comprehensive Developmental Inventory for Infants and Toddlers

    Time frame: baseline, 6 months, 12 months

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

    Bruininks- Oseretsky Test of Motor Proficiency II short form

    Time frame: baseline, 6 months, 12 months

  3. Change from baseline of Sensory and Perceptual function in 6 months and 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)

    Time frame: baseline, 6 months, 12 months

  4. Change from baseline of Participation in 6 months and 12 months

    Children Assessment of Participation and Enjoyment(CAPE): Applicable to children or adolescents between the ages of six and twenty one, through questionnaires through self-reports or interviews, a total of 49 questions, asking children about the activities involved in the past four months (1 point for yes, 0 for no).

    Time frame: baseline, 6 months, 12 months

  5. Change from baseline of Participation in 6 months and 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).

    Time frame: baseline, 6 months, 12 months

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

    Test of Visual Perceptual Skills-Third Edition

    Time frame: baseline, 6 months, 12 months

Secondary outcomes

  1. Change from baseline of lower extremity function & structures in 6 months and 12 months

    Pediatric Balance Scale:The Pediatric Balance Scale (PBS) is a 14-item measure of functional balance for children, ages 2 to 13 years. It was developed through modifications of the Berg Balance Scale to identify children who lack appropriate functional balance and thus may be at risk for developmental delay and injury. The PBS is also used to identify change in functional balance with intervention. The score for each item is from 0 (lowest function) to 4 (highest function). The total maximum score that refers to the best function, is 56.

    Time frame: baseline, 6 months, 12 months

  2. Change from baseline of activities in 6 months and 12 months

    Functional Independence Measure for Children:Applicable to infants and adolescents. The main purpose is to understand and track children's life function performance, progress and goal achievement. There are three main areas: self-care, mobility, and cognition. The score is from 1 to 7 points, 1 is completely dependent, and 7 is completely independent.

    Time frame: baseline, 6 months, 12 months

  3. Change from baseline of Quality of Life in 6 months and 12 months

    TNO-AZL Child Quality of Life Questionnaire (TACQOL): The TACQOL is for children aged from 8 to 15. The questionnaire can be done by the parents or the children themselves for children's health status. The TACQOL contains 56 items with 7 domains (physical functioning, motor, autonomous, cognitive, social, positive moods, and negative moods). There are 8 items in each domain. For physical functioning, motor, autonomous, cognitive and social domains, the scoring is from 0 (never) to 3 (often), followed by a question of child's feeling (3: fine, 2: not so good, 1: quite bad or 0: bad). Items are scored by assigning a value of 4 to the 'never' response, a value of 3 to a 'feeling fine' response, a value of 2 to a 'feeling not so good' response, a value of 1 to a 'feeling quite bad' response and a value of 0 to a 'feeling bad' response. For moods, the scoring is from 0 (never) to 3 (often). The minimal score is 0, and the maximal score is 219.

    Time frame: baseline, 6 months, 12 months

  4. Change from baseline of Personal & Environment factor in 6 months and 12 months

    Parenting Stress Index:Screening and triage measure for evaluating the parenting system and identifying issues that may lead to problems in the child's or parent's behavior. Focuses on three major domains of stress: child characteristics, parent characteristics and situational/demographic life stress.

    Time frame: baseline, 6 months, 12 months

  5. Change from baseline of Rehabilitation & community service factor in 6 months and 12 months

    Measure of Processes of Care: It is to assess parents' perceptions of the care they and their children receive from children's rehabilitation treatment centers. It is a means to assess family-centered behaviors of health care providers. There are 20 items. For each item, a question begins with "To what extent do the people who work with your child," with a 7-point scale with the statement "the service provider engaged in this behavior to a very great extent" (7 point) and "not at all" (1 point). 0 point refers to "not applicable. For each item, the minimal score is 0, and the maximum is 7. A scale score is obtained by calculating the average of the items' ratings. There is no total score.

    Time frame: baseline, 6 months, 12 months

  6. Change from baseline of Social Responsiveness Scale in 6 months and 12 months

    his scale is suitable for children aged 4-18. It is evaluated by 65 questions whether there is a social disorder. The child is identified as autism. The score is 0-3, 0 is untrue, and 3 is descriptive.

    Time frame: baseline, 6 months, 12 months

  7. Change from baseline of facial expression in 6 months and 12 months

    Taiwanese facial expression database:According to Yangming University database, select black and white pictures, strong expression versions, and select five questions of happiness, anger, sadness, fear, and neutrality, a total of 20 questions, each question is taken in four ways, each emotion is in each question will only appear at most, and will be randomly distributed and presented on the computer. The child will specify the specified mood, 1 point for each question, up to 20 points.

    Time frame: baseline, 6 months, 12 months

  8. Change from baseline of Clancy Behavior Scale in 6 months and 12 months

    This scale is suitable for children aged 2-5, a total of 14 questionnaires, about 10 minutes of test, mainly used to screen children with autism, three-point scoring, 2 points for frequent, 1 for occasional, 0 for No, the total score is greater than 14 and there is a tendency to autism. If the score is more than 2/3, it is established as a child with autism.

    Time frame: baseline, 6 months, 12 months

  9. Change from baseline of Theory of Mind Inventory-2 in 6 months and 12 months

    A questionnaire for assessing children's social cognition ability, which is a five-point questionnaire for continuity. It can be filled out by parents or filled by children with good reading skills and speaking skills. This scale is suitable for children aged 2-13, including 60 items. Each question is described as a state, including emotional cognition, mental state understanding, pragmatics and other fields. The person who fills the document is marked with "not", "may not "undetermined", "may have", "determined"

    Time frame: baseline, 6 months, 12 months

  10. Change from baseline of Childhood Autism Rating Scale II in 6 months and 12 months

    Applicable to children under the age of six and those with insufficient intelligence or suspected communication at the age of six, used to judge whether children have autism. A total of 15 questions, each topic is divided into 1 to 4 points, the highest total score of 60 points. For high-function groups, the total score \<27.5, non-autistic; between 28 and 33.5 points, there is a tendency to autism; \>33.5 points, there is autism.

    Time frame: baseline, 6 months, 12 months

  11. Change from baseline of Childhood Asperger Syndrome Test in 6 months and 12 months

    This is a set of questionnaires for screening autism traits (social impairment, communication deficit, repetitive behavior) for children with Asperger or high-functioning autism. It is suitable for children aged 4-11 years. The questionnaire is filled out by parents and filled out. The time is about 10 minutes, divided into two points (0, 1 points), a total of 37 questions

    Time frame: baseline, 6 months, 12 months

07

Study locations

1 of 1 sites recruiting
  • Chang Gung Memorial Hospital
    Taoyuan, 333, Taiwan
    • Chia-Ling Chen, MD, PhD · Contact · clingchen@gmail.com · +886-3-3281200
    • Chia-Ling Chen, MD, PhD · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03700190
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Oct 9, 2018
Start date
Aug 1, 2017
Primary completion
Jul 31, 2022 (estimated)
Completion
Oct 31, 2022 (estimated)
Last update
Feb 18, 2022

Study contacts

Chia-Ling Chen, MD, PhD
Contact
clingchen@gmail.com
+886-3-3281200 ext. 8148
Chia-Ling Chen, MD, PhD
study director · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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