- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03333629
Promoting Positive Outcomes for Individuals With ASD: Linking Early Detection, Treatment, and Long-term Outcomes
2023년 2월 13일 업데이트: Diana Robins, Drexel University
Connecting the Dots: An RCT Integrating Standardized ASD Screening, High-Quality Treatment, and Long-Term Outcomes
Autism spectrum disorder (ASD) is defined by impaired social engagement and social communication, and repetitive, restricted, or stereotyped behaviors and interests.
The average age of diagnosis in the US is after the fourth birthday.
However, children who start ASD-specific early intervention have better outcomes than children start later.
The current study will address a gap identified by the US Prevention Services Task Force, namely that children detected through screening respond positively to early intervention.
This study will directly relate early detection strategies to early intervention, and measure the impact of age of intervention onset on outcomes when children are entering kindergarten.
Local pediatric providers will be randomized to provide either usual care, or to an experimental condition in which autism early detection strategies are enhanced through the addition of specific procedures.
Across all sites, 8,000 children will be recruited through their participating pediatric practice.
Qualifying children will receive up to one year of early intensive behavioral intervention, after getting an ASD diagnosis.
Primary outcome measures will include children's cognitive functioning and ASD symptom severity, which will be measured at multiple time points.
The investigators predict that this study will inform early detection strategies which will result in improving children's social and cognitive functioning, mitigating lifespan disability, reducing societal costs, and improving personal well-being and productivity of individuals with ASD.
연구 개요
상세 설명
Autism spectrum disorder (ASD) is a serious neurodevelopmental disorder defined by impaired social engagement and social communication, in addition to the presence of repetitive, restricted, or stereotyped behaviors and interests.
Although many cases of ASD can be detected when children are less than two years old, the average age of diagnosis in the US is still after the fourth birthday.
However, evidence demonstrates that children who start ASD-specific early intervention have better outcomes than children who do not start treatment until later ages.
In 2006 and 2007, American Academy of Pediatrics recommended three early detection approaches to improve identification of children at risk for ASD: ongoing developmental surveillance at every well-child check-up, routine broad developmental screening at three infant/toddler ages, and ASD-specific screening at two toddler ages.
When these early detection strategies are used with all children attending well-child check-ups, the age of ASD detection is lower, and children who are diagnosed have the opportunity to start ASD-specific early intervention at younger ages than if they had not been detected.
Yet in 2016, the US Preventive Services Task Force (USPSTF) indicated that current evidence is insufficient to recommend universal ASD screening, given the lack of experimental studies demonstrating positive outcomes for treated children that are detected through screening.
The current study will address this gap.
This study will directly relate early detection strategies to early intervention, and measure the impact of age of intervention onset on outcomes when children are entering kindergarten.
The study will be conducted by investigators from three sites: Drexel University; the University of California, Davis; and the University of Connecticut.
Local pediatric providers will be enrolled in the study, and their practices will be randomized to provide either usual care, or to an experimental condition in which autism early detection strategies are enhanced through the addition of specific procedures.
Children attending well-child visits at participating practices will then be enrolled.
Across all sites, 8,000 children will be recruited through their participating pediatric practice.
As part of the study, qualifying children will receive up to one year of early intensive behavioral intervention, using an evidence-based manualized treatment.
Primary outcome measures will include children's cognitive functioning and ASD symptom severity, which will be measured at multiple time points.
Exploratory outcomes will include children's adaptive functioning, kindergarten readiness, and social reciprocity, as measured by experimental eye tracking and parent-child interaction ratings.
This study also will examine the impact of the screening intervention on physician attitudes and on parent empowerment and stress.
Finally, investigators will examine potential moderators of outcomes, to determine whether initial symptom severity, cognitive ability, or socioeconomic status affects children's long-term outcomes.
The investigators predict that this study will inform early detection strategies which will result in improving children's social and cognitive functioning, mitigating lifespan disability, reducing societal costs, and improving personal well-being and productivity of individuals with ASD.
연구 유형
중재적
등록 (실제)
2087
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Sacramento, California, 미국, 95817
- University of California, Davis
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Connecticut
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Storrs, Connecticut, 미국, 06269
- University of Connecticut
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Drexel University
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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
1년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- child attended 18 m visiting at participating pediatric practice
- legal guardian is fluent in English or Spanish
Exclusion Criteria:
- child has severe sensory or motor deficit that precludes completing standardized evaluation
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 평행한
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Enhanced early detection
Providers will receive training to administer enhanced early detection strategies.
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standardized screening
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NO_INTERVENTION: Usual care
Providers will not change their early detection strategies, but will be monitored.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in ASD Symptom Severity
기간: Change from pre-treatment to immediately post-treatment; 10 minutes
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ASD symptom severity will be measured with the Brief Observation of Social Communication Change (BOSCC)
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Change from pre-treatment to immediately post-treatment; 10 minutes
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Change in Cognitive Functioning
기간: Change from pre-treatment to immediately post-treatment; 60 minutes
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Cognitive functioning will be measured by the Mullen Scales of Early Learning (MSEL).
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Change from pre-treatment to immediately post-treatment; 60 minutes
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Adaptive Functioning
기간: Immediately post-treatment, 48 m, 60 m; 45 minutes
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Vineland Adaptive Behavior Scales-3
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Immediately post-treatment, 48 m, 60 m; 45 minutes
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ASD 증상 - 보조 조치1
기간: 48m, 60m; 45 분
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자폐증 진단 관찰 일정, 제2판(ADOS-2)
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48m, 60m; 45 분
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Kindergarten Readiness
기간: 60 m; 45 minutes
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Developmental Indicators for the Assessment of Learning-4
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60 m; 45 minutes
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Social Engagement
기간: 처리 직후, 48m, 60m; 15 분
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Eye tracking paradigms will assess aspects of social engagement (i.e., social orienting, motivation, and cognition)
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처리 직후, 48m, 60m; 15 분
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Long-term change in Cognitive Functioning
기간: 48 m, 60 m; 60 minutes
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Cognitive functioning will be measured by the Mullen Scales of Early Learning (MSEL)
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48 m, 60 m; 60 minutes
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Parent-Child Social Engagement
기간: Immediately post-treatment, 48 m, 60 m; 15 minutes
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Parent-child social engagement will be measured with the Joint Engagement Rating Inventory, which is applied to video recordings of the Communication Play Protocol.
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Immediately post-treatment, 48 m, 60 m; 15 minutes
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ASD symptoms - secondary measure2
기간: Immediately post-treatment, 48 m, 60 m; 20 minutes
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PDD Behavior Inventory
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Immediately post-treatment, 48 m, 60 m; 20 minutes
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ASD symptoms - secondary measure3
기간: 48 m, 60 m; 10 minutes
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BOSCC
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48 m, 60 m; 10 minutes
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인지 기능의 장기적인 변화(대안)
기간: 48m, 60m; 60분
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그리고 MSEL에서 최고점에 도달한 아동의 경우 Differential Differential Abilities Scales-II(DAS-II)를 사용할 것입니다.
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48m, 60m; 60분
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Diana Robins, PhD, Drexel University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 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 11월 29일
기본 완료 (예상)
2023년 6월 30일
연구 완료 (예상)
2023년 6월 30일
연구 등록 날짜
최초 제출
2017년 9월 8일
QC 기준을 충족하는 최초 제출
2017년 11월 3일
처음 게시됨 (실제)
2017년 11월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2023년 2월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2023년 2월 13일
마지막으로 확인됨
2023년 2월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- R01MH115715 (NIH : 국립보건원)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Data will be uploaded to the National Database for Autism Research (NDAR) semi-annually
IPD 공유 기간
semi-annual uploads beginning December 2018
IPD 공유 액세스 기준
as per NDAR requirements
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
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. .
자폐 스펙트럼 장애에 대한 임상 시험
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University Hospital, Basel, SwitzerlandGebert Rüf-Stiftung모집하지 않고 적극적으로ESBL(Extended Spectrum Beta Lactamases) 대장균스위스
Enhanced early detection에 대한 임상 시험
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Saranas, Inc.Cardiovascular Research Foundation, New York; Proxima Clinical Research, Inc.완전한
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Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Boston아직 모집하지 않음자살 생각 | 자살 시도 | 자살
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Duke UniversityUniversity of North Carolina, Chapel Hill; University of North Carolina, Greensboro; UConn...완전한
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Johns Hopkins Bloomberg School of Public HealthUnited States Agency for International Development (USAID)모병