一项多中心随机对照两阶段试验：早期丹佛模式与常规治疗的比较。
A Multisite Randomized Controlled Two-Phase Trial of the Early Start Denver Model Compared to Treatment as Usual.
机构信息
University of California, Davis, MIND Institute, Sacramento.
University of Washington, Seattle.
出版信息
J Am Acad Child Adolesc Psychiatry. 2019 Sep;58(9):853-865. doi: 10.1016/j.jaac.2019.01.004. Epub 2019 Jan 24.
OBJECTIVE
This single-blind, randomized, multisite, intent-to-treat study was designed to replicate and extend Dawson et al.'s (Pediatrics. 2010;125: e17-e23) randomized controlled trial testing the effects of the Early Start Denver Model (ESDM), an intensive play- and routines-based intervention delivered in natural settings.
METHOD
A randomized controlled trial was conducted at 3 universities. One hundred eighteen children 14 to 24 months old with autism spectrum disorder were enrolled and randomly assigned to ESDM or community interventions for 27 months. Eighty-one children completed the full treatment course and all assessments; data from all 118 children were used in analyses. Children assigned to the ESDM intervention received 3 months of weekly parent coaching followed by 24 months of 15 hour per week (on average) 1:1 treatment weekly on average in homes or daycare settings from supervised therapy assistants while parents received coaching 4 hours monthly from a certified ESDM therapist.
RESULTS
For the primary analyses, there were time-by-group and time-by-group-by-site interactions for language outcome. In the significant 3-way interaction involving site, 2 sites showed a significant ESDM advantage and the third site showed no significant group differences. In the planned 2-way analysis that pooled data across all 3 sites, there was a significant advantage found for the ESDM group. For the secondary analyses, there were no significant differences between the ESDM and community groups involving developmental quotient, autism severity, or adaptive behavior. The treatment effect of group on language outcomes was not moderated by baseline developmental quotient, autism severity, or language.
CONCLUSION
Results of the primary analysis provide a partial replication of Dawson et al.'s 2010 language findings.
CLINICAL TRIAL REGISTRATION INFORMATION
Intensive Intervention for Toddlers with Autism; https://clinicaltrials.gov/; NCT00698997.
目的
本单盲、随机、多中心、意向治疗研究旨在复制和扩展 Dawson 等人的研究（儿科学。2010；125：e17-e23），该研究测试了早期开始丹佛模式（ESDM）的效果，ESDM 是一种在自然环境中进行的基于游戏和常规的密集干预。
方法
在 3 所大学进行了一项随机对照试验。共招募了 118 名 14 至 24 个月大的自闭症谱系障碍儿童，并随机分为 ESDM 组或社区干预组，进行 27 个月的治疗。81 名儿童完成了完整的治疗疗程和所有评估；所有 118 名儿童的数据均用于分析。被分配到 ESDM 干预组的儿童接受了 3 个月的每周家长培训，然后在 24 个月内，每周平均有 15 小时（平均）的 1:1 治疗，在家庭或日托环境中由监督治疗助理进行，同时父母每月从认证的 ESDM 治疗师那里接受 4 小时的辅导。
结果
对于主要分析，语言结果存在时间-组和时间-组-地点交互作用。在涉及地点的显著 3 向交互作用中，2 个地点显示 ESDM 有显著优势，第 3 个地点则没有显著的组间差异。在对所有 3 个地点的数据进行汇总的计划 2 向分析中，ESDM 组有显著优势。对于次要分析，在 ESDM 组和社区组之间，发育商、自闭症严重程度或适应行为均无显著差异。组对语言结果的治疗效果不受基线发育商、自闭症严重程度或语言的影响。
结论
主要分析结果部分复制了 Dawson 等人 2010 年的语言发现。
临床试验注册信息
自闭症儿童强化干预；https://clinicaltrials.gov/；NCT00698997。
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