- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01655485
Effect of a Social Script iPAD Application for Children With Autism Spectrum Disorder
Effect of a Social Script iPAD Application for Children With Autism Spectrum Disorder(ASD) Undergoing Medical Imaging Procedures
The purpose of the research is to test the effectiveness of the social story intervention delivered using the iPAD application "Going to Imaging" on the anxiety, challenging child behaviors, child injuries and completion rates among children with ASD undergoing medical imaging procedures. A secondary purpose is to test the effect of this intervention on the anxiety levels of the parents of ASD children undergoing medical imaging procedures.
Hypotheses:
H1: Children with ASD who are exposed to a story book "Here the investigators go to medical imaging (x-ray)" to prepare for medical imaging compared with children with ASD exposed to treatment as usual (TAU) will have:
- Lower anxiety as measured by heart rate respiratory rate, and blood pressure (baseline compared to up to two hours later).
- Exhibit fewer challenging behaviors as measured by a behavior observation scale (developed for the study (up to 2 hours after baseline)
- Higher procedure completion rate.
- Shorter time to complete a procedure.
Less child injuries.
H2: Compared to parents of ASD children exposed to treatment as usual (TAU), parents of children with ASD who are exposed to a story book "Here the investigators go to medical imaging (x-ray)" to prepare for medical imaging will have:
- Lower state anxiety as measured by the State Anxiety Inventory ( baseline ).
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53201
- Children's Hospital of Wisconsin
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Children with autism spectrum disorder
- English speaking parent or guardian.
Exclusion Criteria:
- Non-english speaking parent or guardian
- Severe autism as defined by caregiver or health care provider.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Patient teaching
ipad application for social script book
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The Social script application is an story book on the iPAD with photos and script explaining the steps of getting a medical image such as a CAT scan from the perspective of the child.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Child behaviors
기간: up to 2 hours
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Child behaviors measured during imaging procedures with the behaviors observation tool created for this study.
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up to 2 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Parent anxiety
기간: Baseline
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State anxiety measure www.mindgarden.com
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Baseline
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Child anxiety
기간: Baseline
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Vital signs
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Baseline
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Change in parent anxiety
기간: Change from baseline in state anxiety measure to 30 minutes later
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Parent anxiety is measured at baseline www.mindgarden.com
and again after the intervention to see if there is a change.
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Change from baseline in state anxiety measure to 30 minutes later
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Change in child anxiety
기간: change in child anxiety from baseline to 30 minutes later
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Child anxiety is measured at baseline vital signs and again after the intervention to see if there is a change.
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change in child anxiety from baseline to 30 minutes later
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공동 작업자 및 조사자
수사관
- 수석 연구원: Norah L Johnson, PhD, Children's Hospital and Health System Foundation, Wisconsin
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 255769-1
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. .
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Oslo University HospitalThe Research Council of Norway완전한림프종 | 백혈병 | 암 | 줄기세포 이식
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University of California, DavisNational Institute of Mental Health (NIMH)모병