- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03700190
The Predictors for Activity and Participation in Children With ASD: A Follow-up Study
2022년 2월 17일 업데이트: Chang Gung Memorial Hospital
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
연구 개요
상태
모병
정황
상세 설명
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.
연구 유형
관찰
등록 (예상)
180
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Taoyuan, 대만, 333
- 모병
- Chang Gung Memorial Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
2년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
This study is a prospective and follow-up study.
Children with Autism Spectrum Disorder and Typical Developmental, aged 2-18 years.
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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제어
건강한 아이
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Experimental
Patients with Autism Spectrum Disorder
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from baseline of general developmental for Healthy child and patients with Autism Spectrum Disorder in 6 months and 12 months
기간: baseline, 6 months, 12 months
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Comprehensive Developmental Inventory for Infants and Toddlers
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baseline, 6 months, 12 months
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Change from baseline of body function & structures in 6 months and 12 months
기간: baseline, 6 months, 12 months
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Bruininks- Oseretsky Test of Motor Proficiency II short form
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baseline, 6 months, 12 months
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Change from baseline of Sensory and Perceptual function in 6 months and 12 months
기간: baseline, 6 months, 12 months
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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)
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baseline, 6 months, 12 months
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Change from baseline of Participation in 6 months and 12 months
기간: baseline, 6 months, 12 months
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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).
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baseline, 6 months, 12 months
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Change from baseline of Participation in 6 months and 12 months
기간: baseline, 6 months, 12 months
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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).
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baseline, 6 months, 12 months
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Change from baseline of Visual Perception in 6 months and 12 months
기간: baseline, 6 months, 12 months
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Test of Visual Perceptual Skills-Third Edition
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baseline, 6 months, 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline of lower extremity function & structures in 6 months and 12 months
기간: baseline, 6 months, 12 months
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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.
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baseline, 6 months, 12 months
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Change from baseline of activities in 6 months and 12 months
기간: baseline, 6 months, 12 months
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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.
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baseline, 6 months, 12 months
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Change from baseline of Quality of Life in 6 months and 12 months
기간: baseline, 6 months, 12 months
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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.
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baseline, 6 months, 12 months
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Change from baseline of Personal & Environment factor in 6 months and 12 months
기간: baseline, 6 months, 12 months
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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.
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baseline, 6 months, 12 months
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Change from baseline of Rehabilitation & community service factor in 6 months and 12 months
기간: baseline, 6 months, 12 months
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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.
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baseline, 6 months, 12 months
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Change from baseline of Social Responsiveness Scale in 6 months and 12 months
기간: baseline, 6 months, 12 months
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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.
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baseline, 6 months, 12 months
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Change from baseline of facial expression in 6 months and 12 months
기간: baseline, 6 months, 12 months
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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.
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baseline, 6 months, 12 months
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Change from baseline of Clancy Behavior Scale in 6 months and 12 months
기간: baseline, 6 months, 12 months
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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.
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baseline, 6 months, 12 months
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Change from baseline of Theory of Mind Inventory-2 in 6 months and 12 months
기간: baseline, 6 months, 12 months
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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"
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baseline, 6 months, 12 months
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Change from baseline of Childhood Autism Rating Scale II in 6 months and 12 months
기간: baseline, 6 months, 12 months
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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.
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baseline, 6 months, 12 months
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Change from baseline of Childhood Asperger Syndrome Test in 6 months and 12 months
기간: baseline, 6 months, 12 months
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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
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baseline, 6 months, 12 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 8월 1일
기본 완료 (예상)
2022년 7월 31일
연구 완료 (예상)
2022년 10월 31일
연구 등록 날짜
최초 제출
2018년 5월 11일
QC 기준을 충족하는 최초 제출
2018년 10월 8일
처음 게시됨 (실제)
2018년 10월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 2월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 2월 17일
마지막으로 확인됨
2022년 2월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 201601949B0
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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아니
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .