Effect of Wearable Digital Intervention for Improving Socialization in Children With Autism Spectrum Disorder A Randomized Clinical Trial
Effect of Wearable Digital Intervention for Improving Socialization in Children With Autism Spectrum Disorder A Randomized Clinical Trial
复制标题
可穿戴数字干预对改善自闭症谱系障碍儿童社交的影响：一项随机临床试验
DOI：
10.1001/jamapediatrics.2019.0285
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发表时间：
2019-05-01
期刊：
影响因子：
26.1
通讯作者：
Wall, Dennis P.
中科院分区：
文献类型：
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作者：
Voss, Catalin;Schwartz, Jessey;Wall, Dennis P.
重要性 自闭症行为疗法是有效的，但昂贵且难以获得。虽然基于移动技术的治疗可以减少等候名单和扩大需求，但很少有临床试验支持其用于自闭症谱系障碍 (ASD) 护理。 目的 评估 Superpower Glass 的功效，这是一种人工智能驱动的可穿戴行为干预措施，用于改善 ASD 儿童的社会结果。 设计、设置和参与者 一项随机临床试验，其中参与者接受 Superpower Glass 干预加上标准护理应用行为分析治疗，对照参与者仅接受应用行为分析治疗。评估在斯坦福大学医学院完成，注册参与者在家中使用了 Superpower Glass 干预措施。被正式诊断为自闭症谱系障碍 (ASD) 且目前正在接受应用行为分析治疗的 6 至 12 岁儿童也被纳入其中。家庭招募于 2016 年 6 月至 2017 年 12 月期间进行。第一位参与者于 2016 年 11 月 1 日注册，最后一次预约于 2018 年 4 月 11 日完成。数据分析于 2018 年 4 月至 10 月期间进行。 干预措施 Superpower Glass 干预措施通过 Google Glass（由儿童佩戴）和智能手机应用程序部署，通过检测面部表情并提供强化社交线索来促进面部参与和情绪识别。要求家庭每周 4 次在家进行 20 分钟的课程，持续 6 周。 主要结果和措施 使用意向治疗分析和 Bonferroni 检验校正来评估四种社会化措施。 结果 总体而言，71 名诊断患有 ASD 的儿童（63 名男孩 [89%]；平均 [SD] 年龄，8.38 [2.46] 岁）被纳入其中（40 名 [56.3%] 被随机分配到治疗，31 例（43.7%）被随机分配至对照组）。与常规对照治疗相比，接受干预的儿童在瓦恩兰适应行为量表社交子量表上表现出显着改善（平均[SD]治疗影响，4.58 [1.62]；P =.005）。其他 3 项主要指标也发现了积极的平均治疗效果，但未达到 P = 0.0125 的显着性阈值。 结论和相关性 在 Vineland 适应行为量表社会化子量表上观察到的 4.58 分平均增益与标准护理治疗中观察到的增益相当。据我们所知，这是第一个随机临床试验，证明可穿戴数字干预措施对改善自闭症儿童社交行为的功效。这种干预措施增强了面部参与度和情绪识别，表明其中之一或两者都可能是推动所观察到的改善的作用机制。这项研究强调了数字家庭治疗在提高护理标准方面的潜力。
IMPORTANCE Autism behavioral therapy is effective but expensive and difficult to access. While mobile technology-based therapy can alleviate wait-lists and scale for increasing demand, few clinical trials exist to support its use for autism spectrum disorder (ASD) care.OBJECTIVE To evaluate the efficacy of Superpower Glass, an artificial intelligence-driven wearable behavioral intervention for improving social outcomes of children with ASD.DESIGN, SETTING, AND PARTICIPANTS A randomized clinical trial in which participants received the Superpower Glass intervention plus standard of care applied behavioral analysis therapy and control participants received only applied behavioral analysis therapy. Assessments were completed at the Stanford University Medical School, and enrolled participants used the Superpower Glass intervention in their homes. Children aged 6 to 12 years with a formal ASD diagnosis who were currently receiving applied behavioral analysis therapy were included. Families were recruited between June 2016 and December 2017. The first participant was enrolled on November 1, 2016, and the last appointment was completed on April 11, 2018. Data analysis was conducted between April and October 2018.INTERVENTIONS The Superpower Glass intervention, deployed via Google Glass (worn by the child) and a smartphone app, promotes facial engagement and emotion recognition by detecting facial expressions and providing reinforcing social cues. Families were asked to conduct 20-minute sessions at home 4 times per week for 6 weeks.MAIN OUTCOMES AND MEASURES Four socialization measures were assessed using an intention-to-treat analysis with a Bonferroni test correction.RESULTS Overall, 71children (63 boys [89%]; mean [SD] age, 8.38 [2.46] years) diagnosed with ASD were enrolled (40 [56.3%] were randomized to treatment, and 31(43.7%) were randomized to control). Children receiving the intervention showed significant improvements on the Vineland Adaptive Behaviors Scale socialization subscale compared with treatment as usual controls (mean [SD] treatment impact, 4.58 [1.62]; P =.005). Positive mean treatment effects were also found for the other 3 primary measures but not to a significance threshold of P =.0125.CONCLUSIONS AND RELEVANCE The observed 4.58-point average gain on the Vineland Adaptive Behaviors Scale socialization subscale is comparable with gains observed with standard of care therapy. To our knowledge, this is the first randomized clinical trial to demonstrate efficacy of a wearable digital intervention to improve social behavior of children with ASD. The intervention reinforces facial engagement and emotion recognition, suggesting either or both could be a mechanism of action driving the observed improvement. This study underscores the potential of digital home therapy to augment the standard of care.