Connecting the Dots: a cluster-randomized clinical trial integrating standardized autism spectrum disorders screening, high-quality treatment, and long-term outcomes.
Connecting the Dots: a cluster-randomized clinical trial integrating standardized autism spectrum disorders screening, high-quality treatment, and long-term outcomes.
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连接点：一项集群临床试验，整合了标准化的自闭症谱系筛查，高质量治疗和长期结局。
DOI：
10.1186/s13063-021-05286-6
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发表时间：
2021-05-02
期刊：
影响因子：
2.5
通讯作者：
Robins DL
中科院分区：
文献类型：
--
作者：
McClure LA;Lee NL;Sand K;Vivanti G;Fein D;Stahmer A;Robins DL
在美国，每54名儿童中就有1名患有自闭症谱系障碍（ASD），在整个生命周期中为ASD患者提供支持是一项挑战，对个人、家庭和社区都有影响，而且成本相当高昂。美国儿科学会（American Academy of Pediatrics）建议在18个月和24个月时进行常规的自闭症谱系障碍筛查，但一些研究表明，很少有儿科医生能普遍进行高保真、标准化的筛查。此外，美国预防服务工作组（USPSTF）没有找到足够的证据来推荐或反对普遍的ASD筛查。这项研究的目的是验证一个假设，即自闭症儿童具有高保真度；与接受常规护理的儿童相比，标准化筛查将在5岁时取得更好的结果。这是一项在美国3个地点进行的集群随机对照临床试验。儿科实践将随机化，实施普遍、标准化、高保真的幼儿筛查或常规护理，随机化按实践规模分层。该研究将招募3450名儿童，每组约占一半。从这个样本中，我们预计将有100名儿童被诊断为自闭症谱系障碍。两组接受ASD诊断的儿童都将接受早期启动丹佛模式，这是一种基于证据的早期干预，针对社会、沟通和认知功能。治疗将持续1年，每周治疗ASD患儿20小时。在基线、治疗后以及4岁和5岁时测量的主要结局包括ASD症状严重程度（社会交流变化简要观察（BOSCC））和认知功能（马伦早期学习量表（MSEL）和差异能力量表- ii (DAS-II)）。儿童的次要结局包括适应功能、ASD症状和幼儿园准备程度的测量；二级分析还将检查父母之间的压力和授权。还将包括一些新的探索性措施。该研究将采用改良的意向治疗分析。该试验将评估对18个月大的儿童进行普遍、标准化、高保真的ASD筛查的影响，目的是提供证据支持这种检测幼儿ASD的策略，以便尽可能早地开始治疗并最大化结果。本研究由Drexel大学机构审查委员会批准（IRB协议：1607004653）。所有研究结果将由首席研究员通过电子邮件提供；数据将通过NIMH数据档案（https://nda.nih.gov/）提供。ClinicalTrials.gov NCT03333629。在线报名日期为2017年11月7日，包含补充资料，下载地址：10.1186/s13063-021-05286-6。
Autism spectrum disorder (ASD) affects one in 54 children in the United States of America, and supporting people with ASD across the lifespan presents challenges that impact individuals, families, and communities and can be quite costly. The American Academy of Pediatrics has issued recommendations for routine ASD screening at 18 and 24 months, but some research suggests that few pediatricians perform high-fidelity, standardized screening universally. Furthermore, the United States Preventive Services Task Force (USPSTF) found insufficient evidence to recommend for or against universal ASD screening. The objective of this study is to test the hypothesis that children with ASD who have high fidelity; standardized screening will achieve superior outcomes at 5 years of age compared to children receiving usual care ASD detection strategies. This is a cluster-randomized, controlled clinical trial in 3 sites in the USA. Pediatric practices will be randomized to implement universal, standardized, high-fidelity toddler screening or usual care, with randomization stratified by the practice size. The study will enroll 3450 children, approximately half in each group. From this sample, we anticipate 100 children to be diagnosed with ASD. Children in both groups receiving an ASD diagnosis will be administered the Early Start Denver Model, an evidence-based early intervention addressing social, communication, and cognitive functioning. Treatment will last for 1 year, with up to 20 h per week of therapy for children with ASD. Primary outcomes measured at baseline, following treatment, and at 4 and 5 years of age include ASD symptom severity (Brief Observation of Social Communication Change (BOSCC)) and cognitive functioning (Mullen Scales of Early Learning (MSEL) and Differential Abilities Scale-II (DAS-II)). Secondary outcomes in children include measures of adaptive functioning, ASD symptoms, and kindergarten readiness; secondary analyses will also examine stress and empowerment among parents. Several novel exploratory measures will be included as well. The study will utilize a modified intention-to-treat analysis. This trial will evaluate the impact of universal, standardized, high-fidelity screening for ASD among children at 18 months of age, with a goal of providing evidence to support this strategy to detect ASD in toddlers in order to start treatment as young as possible and maximize outcomes. This study was approved by the Institutional Review Board at Drexel University (IRB protocol: 1607004653). All findings will be provided by the principal investigator via email; data will be available through the NIMH Data Archive (https://nda.nih.gov/). ClinicalTrials.gov NCT03333629. Registered on November 7, 2017 The online version contains supplementary material available at 10.1186/s13063-021-05286-6.
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影响因子：
1.1
作者：
Arunyanart, Wirongrong;Fenick, Ada;Weitzman, Carol
通讯作者：
Weitzman, Carol
DOI：
10.1080/09540261.2018.1432574
发表时间：
2018-03
期刊：
International review of psychiatry (Abingdon, England)
影响因子：
--
作者：
Landa RJ
通讯作者：
Landa RJ
DOI：
10.1097/dbp.0000000000000014
发表时间：
2014-02-01
影响因子：
2.4
作者：
Herlihy, Lauren E.;Brooks, Bianca;Robins, Diana L.
通讯作者：
Robins, Diana L.
影响因子：
3.9
作者：
Cohen, IL;Schmidt-Lackner, S;Sudhalter, V
通讯作者：
Sudhalter, V
影响因子：
5.8
作者：
Kreidler, Sarah M.;Muller, Keith E.;Glueck, Deborah H.
通讯作者：
Glueck, Deborah H.