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Promoting Positive Outcomes for Individuals With ASD: Linking Early Detection, Treatment, and Long-term Outcomes

2023年2月13日 更新者: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.

研究概览

地位

主动,不招人

详细说明

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.

研究类型

介入性

注册 (实际的)

2087

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Sacramento、California、美国、95817
        • University of California, Davis
    • Connecticut
      • Storrs、Connecticut、美国、06269
        • University Of Connecticut
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Drexel University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1年 至 4年 (孩子)

接受健康志愿者

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:放映
  • 分配:随机化
  • 介入模型:平行线
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Enhanced early detection
Providers will receive training to administer enhanced early detection strategies.
standardized screening
NO_INTERVENTION:Usual care
Providers will not change their early detection strategies, but will be monitored.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in ASD Symptom Severity
大体时间:Change from pre-treatment to immediately post-treatment; 10 minutes
ASD symptom severity will be measured with the Brief Observation of Social Communication Change (BOSCC)
Change from pre-treatment to immediately post-treatment; 10 minutes
Change in Cognitive Functioning
大体时间:Change from pre-treatment to immediately post-treatment; 60 minutes
Cognitive functioning will be measured by the Mullen Scales of Early Learning (MSEL).
Change from pre-treatment to immediately post-treatment; 60 minutes

次要结果测量

结果测量
措施说明
大体时间
Adaptive Functioning
大体时间:Immediately post-treatment, 48 m, 60 m; 45 minutes
Vineland Adaptive Behavior Scales-3
Immediately post-treatment, 48 m, 60 m; 45 minutes
ASD 症状 - 次要措施 1
大体时间:48米、60米; 45分钟
自闭症诊断观察时间表,第二版 (ADOS-2)
48米、60米; 45分钟
Kindergarten Readiness
大体时间:60 m; 45 minutes
Developmental Indicators for the Assessment of Learning-4
60 m; 45 minutes
Social Engagement
大体时间:立即处理后,48 m、60 m; 15分钟
Eye tracking paradigms will assess aspects of social engagement (i.e., social orienting, motivation, and cognition)
立即处理后,48 m、60 m; 15分钟
Long-term change in Cognitive Functioning
大体时间:48 m, 60 m; 60 minutes
Cognitive functioning will be measured by the Mullen Scales of Early Learning (MSEL)
48 m, 60 m; 60 minutes
Parent-Child Social Engagement
大体时间:Immediately post-treatment, 48 m, 60 m; 15 minutes
Parent-child social engagement will be measured with the Joint Engagement Rating Inventory, which is applied to video recordings of the Communication Play Protocol.
Immediately post-treatment, 48 m, 60 m; 15 minutes
ASD symptoms - secondary measure2
大体时间:Immediately post-treatment, 48 m, 60 m; 20 minutes
PDD Behavior Inventory
Immediately post-treatment, 48 m, 60 m; 20 minutes
ASD symptoms - secondary measure3
大体时间:48 m, 60 m; 10 minutes
BOSCC
48 m, 60 m; 10 minutes
认知功能的长期变化(替代)
大体时间:48米、60米; 60分钟
对于达到 MSEL 上限的儿童,我们将使用差异差异能力量表-II (DAS-II) 将用于对于结果 7 来说太高的儿童
48米、60米; 60分钟

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Diana Robins, PhD、Drexel University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年11月29日

初级完成 (预期的)

2023年6月30日

研究完成 (预期的)

2023年6月30日

研究注册日期

首次提交

2017年9月8日

首先提交符合 QC 标准的

2017年11月3日

首次发布 (实际的)

2017年11月7日

研究记录更新

最后更新发布 (估计)

2023年2月14日

上次提交的符合 QC 标准的更新

2023年2月13日

最后验证

2023年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • R01MH115715 (NIH)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Data will be uploaded to the National Database for Autism Research (NDAR) semi-annually

IPD 共享时间框架

semi-annual uploads beginning December 2018

IPD 共享访问标准

as per NDAR requirements

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

自闭症谱系障碍的临床试验

  • Hospital Universitari Vall d'Hebron Research Institute
    Instituto de Salud Carlos III
    完全的
    小肠运动障碍 (Disorder)
    西班牙
  • Dren Bio
    Novotech
    招聘中
    侵袭性 NK 细胞白血病 | 肝脾T细胞淋巴瘤 | 肠病相关的T细胞淋巴瘤 | 皮下脂膜炎样 T 细胞淋巴瘤 | 单形性趋上皮性肠 T 细胞淋巴瘤 | LGLL - 大颗粒淋巴细胞白血病 | 原发性皮肤 T 细胞淋巴瘤 - 类别 | 原发性皮肤 CD8 阳性侵袭性嗜表皮 T 细胞淋巴瘤 | 系统性 EBV1 T 细胞淋巴瘤,如果 CD8 阳性 | Hydroa Vacciniforme-Like Lymphoproliferative Disorder | 结外 NK/T 细胞淋巴瘤,鼻型 | 胃肠道惰性慢性淋巴增生性疾病 (CLPD)(CD8+ 或 NK 衍生) | 上面未列出的其他 CD8+/NK 细胞驱动的淋巴瘤
    美国, 澳大利亚, 法国, 西班牙
  • Memorial Sloan Kettering Cancer Center
    招聘中
    蕈样肉芽肿 | 塞扎里综合症 | 血管免疫母细胞性T细胞淋巴瘤 | 肝脾T细胞淋巴瘤 | 间变性大细胞淋巴瘤,ALK 阳性 | 结外 NK/T 细胞淋巴瘤,鼻型 | T细胞淋巴瘤 | 未特指的外周 T 细胞淋巴瘤 | 原发性皮肤间变性大细胞淋巴瘤 | 皮下脂膜炎样 T 细胞淋巴瘤 | 肠病相关的T细胞淋巴瘤 | 间变性大细胞淋巴瘤,ALK 阴性 | 单形性趋上皮性肠 T 细胞淋巴瘤 | T 细胞幼淋巴细胞白血病 | T 细胞大颗粒淋巴细胞白血病 | 原发性皮肤 CD8 阳性侵袭性嗜表皮 T 细胞淋巴瘤 | Hydroa Vacciniforme-Like Lymphoproliferative Disorder | NK细胞淋巴瘤 | 侵袭性 NK 细胞白血病 | 成人 T 细胞白血病/淋巴瘤 及其他条件
    美国

Enhanced early detection的临床试验

3
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