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.

中文翻译：

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与常规治疗相比，早期启动丹佛模型的多站点随机对照两阶段试验。

客观的

这项单盲，随机，多站点，意图治疗研究旨在复制和扩展Dawson等人的研究。的（Pediatrics。2010; 125：e17-e23）随机对照试验，用于测试“早起丹佛模型”（ESDM）的效果，该模型是在自然环境中进行的基于运动和常规训练的密集干预。

方法

在3所大学进行了一项随机对照试验。招募了114名自闭症谱系障碍的14至24个月大的儿童，并随机分配给他们进行ESDM或社区干预27个月。81名儿童完成了全部治疗过程和所有评估；所有118名儿童的数据均用于分析。分配给ESDM干预的孩子每周接受3个月的父母指导，然后每周24个月（平均）每周15个小时（平均）在有监督的治疗助手的家庭或日托环境中每周1：1接受治疗，而父母则每月接受4个小时的指导认证的ESDM治疗师。

结果

对于主要分析，对于语言结果，存在按组和按组按时间的交互。在涉及站点的重要三向交互中，有两个站点显示出显着的ESDM优势，而第三个站点则没有显着的组差异。在计划的双向分析中汇总了所有3个站点的数据，对于ESDM组而言，它具有显着的优势。对于次要分析，ESDM与社区群体之间在发育商，自闭症严重程度或适应性行为方面无显着差异。基线发育商，自闭症严重程度或语言并不能缓解该组对语言结局的治疗效果。

结论

初步分析的结果提供了Dawson等人的部分复制。的2010年语言调查结果。

临床试验注册信息

对自闭症幼儿的强化干预；https://clinicaltrials.gov/; NCT00698997。