Autism Spectrum DisorderNCT03700190
The Predictors for Activity and Participation in Children With ASD: A Follow-up Study
An observational study of Autism Spectrum Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Developmental function and Participation in life and school activities in patients with autism spectrum disorder: A follow-up study Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This study is a prospective and follow-up study. Children with Autism Spectrum Disorder and Typical Developmental, aged 2-18 years.
Who may be able to join
- Patients with Autism Spectrum Disorder
- Age 2-18 y/o
- Agree to sign informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Chia-Ling Chen, MD, PhD, +886-3-3281200 ext. 8148, clingchen@gmail.com
Chia-Ling Chen, MD, PhD
About this study
Official title: Developmental Function and Participation in Life and School Activities in Patients With Autism Spectrum Disorder: A Follow-up Study
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.
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, activity and participation, sensory perception, facial expression, developmental functions, predictors, follow-up study
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Motor Activity, Facial Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy child | |
| Experimental | Patients with Autism Spectrum Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 6 months, 12 months
Change from baseline of body function & structures in 6 months and 12 months
Bruininks- Oseretsky Test of Motor Proficiency II short form
Measured: baseline, 6 months, 12 months
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)
Measured: baseline, 6 months, 12 months
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).
Measured: baseline, 6 months, 12 months
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).
Measured: baseline, 6 months, 12 months
Change from baseline of Visual Perception in 6 months and 12 months
Test of Visual Perceptual Skills-Third Edition
Measured: baseline, 6 months, 12 months
Secondary outcomes (11)
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.
Measured: baseline, 6 months, 12 months
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.
Measured: baseline, 6 months, 12 months
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.
Measured: baseline, 6 months, 12 months
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.
Measured: baseline, 6 months, 12 months
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.
Measured: baseline, 6 months, 12 months
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.
Measured: baseline, 6 months, 12 months
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.
Measured: baseline, 6 months, 12 months
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.
Measured: baseline, 6 months, 12 months
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"
Measured: baseline, 6 months, 12 months
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.
Measured: baseline, 6 months, 12 months
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
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Aug 2017
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, MD, PhD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700190
- Sponsor's protocol ID
- 201601949B0
- Status last verified
- Feb 2022
- First submitted
- 11 May 2018
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Function and Participation in Life and School Activities in Patients With Autism Spectrum Disorder: A Follow-up Study
- ClinicalTrials.gov ID
- NCT03700190
- Acronym / sponsor ID
- 201601949B0
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, activity and participation, sensory perception, facial expression, developmental functions, predictors, follow-up study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Healthy child |
| Experimental | – | –Patients with Autism Spectrum Disorder |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This study is a prospective and follow-up study. Children with Autism Spectrum Disorder and Typical Developmental, aged 2-18 years.
Key inclusion criteria (3 listed)
- Patients with Autism Spectrum Disorder
- Age 2-18 y/o
- Agree to sign informed consent
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 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 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)
Change from baseline of Participation in 6 months and 12 months
Time frame: baseline, 6 months, 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).
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
11 secondary outcomes
Change from baseline of lower extremity function & structures in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of activities in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of Quality of Life in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of Personal & Environment factor in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of Rehabilitation & community service factor in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of Social Responsiveness Scale in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of facial expression in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of Clancy Behavior Scale in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of Theory of Mind Inventory-2 in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of Childhood Autism Rating Scale II in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of Childhood Asperger Syndrome Test in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Ling Chen, MD, PhD study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Ling Chen, MD, PhD (+886-3-3281200 ext. 8148, clingchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.