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出境医 / 临床实验 / The Predictors for Activity and Participation in Children With ASD: A Follow-up Study

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

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

Condition or disease
Autism Spectrum Disorder

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
Layout table for study information
Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developmental Function and Participation in Life and School Activities in Patients With Autism Spectrum Disorder: A Follow-up Study
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : October 31, 2022
Arms and Interventions
Group/Cohort
Control
Healthy child
Experimental
Patients with Autism Spectrum Disorder
Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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).

  5. 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).

  6. 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


Secondary Outcome Measures :
  1. Change from baseline of lower extremity function & structures in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.

  2. Change from baseline of activities in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.

  3. Change from baseline of Quality of Life in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.

  4. Change from baseline of Personal & Environment factor in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.

  5. Change from baseline of Rehabilitation & community service factor in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.

  6. Change from baseline of Social Responsiveness Scale in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.

  7. Change from baseline of facial expression in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.

  8. Change from baseline of Clancy Behavior Scale in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.

  9. Change from baseline of Theory of Mind Inventory-2 in 6 months and 12 months [ Time Frame: baseline, 6 months, 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"

  10. Change from baseline of Childhood Autism Rating Scale II in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.

  11. Change from baseline of Childhood Asperger Syndrome Test in 6 months and 12 months [ Time Frame: baseline, 6 months, 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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.
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)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Chia-Ling Chen, MD, PhD +886-3-3281200 ext 8148 clingchen@gmail.com

Locations
Layout table for location information
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Chia-Ling Chen, MD, PhD    +886-3-3281200 ext 8148    clingchen@gmail.com   
Principal Investigator: Chia-Ling Chen, MD, PhD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Layout table for investigator information
Study Director: Chia-Ling Chen, MD, PhD Chang Gung Memorial Hospital
Tracking Information
First Submitted Date May 11, 2018
First Posted Date October 9, 2018
Last Update Posted Date November 27, 2020
Actual Study Start Date August 1, 2017
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 8, 2018)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 8, 2018)
  • Change from baseline of lower extremity function & structures in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.
  • Change from baseline of activities in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.
  • Change from baseline of Quality of Life in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.
  • Change from baseline of Personal & Environment factor in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.
  • Change from baseline of Rehabilitation & community service factor in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.
  • Change from baseline of Social Responsiveness Scale in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.
  • Change from baseline of facial expression in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.
  • Change from baseline of Clancy Behavior Scale in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.
  • Change from baseline of Theory of Mind Inventory-2 in 6 months and 12 months [ Time Frame: baseline, 6 months, 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"
  • Change from baseline of Childhood Autism Rating Scale II in 6 months and 12 months [ Time Frame: baseline, 6 months, 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.
  • Change from baseline of Childhood Asperger Syndrome Test in 6 months and 12 months [ Time Frame: baseline, 6 months, 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Autism Spectrum Disorder
Intervention Not Provided
Study Groups/Cohorts
  • Control
    Healthy child
  • Experimental
    Patients with Autism Spectrum Disorder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 8, 2018)
180
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2022
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Chia-Ling Chen, MD, PhD +886-3-3281200 ext 8148 clingchen@gmail.com
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03700190
Other Study ID Numbers 201601949B0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Chang Gung Memorial Hospital
Study Sponsor Chang Gung Memorial Hospital
Collaborators Not Provided
Investigators
Study Director: Chia-Ling Chen, MD, PhD Chang Gung Memorial Hospital
PRS Account Chang Gung Memorial Hospital
Verification Date November 2020