Examining adaptive peer-mediated interventions for preschoolers with autism spectrum disorder and limited or no spoken language: A Sequential Multiple Assignment Randomized Trial

检查对患有自闭症谱系障碍且口语有限或没有口语的学龄前儿童的适应性同伴介导干预措施：序贯多重分配随机试验

• 批准号: 10491421
• 负责人: Kathy Thiemann-Bourque
• 金额: $ 57.75万
• 依托单位: UNIVERSITY OF KANSAS LAWRENCE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10491421
• 关键词: Academic achievement; Address; Adopted; Adult; Aftercare; Age; Apple; Blinded; Child; Child Development; Clinical Trials; Communication; Communities; Complex; Data; Development; Early Intervention; Educational Activities; Educational process of instructing; Emotional; Ensure; Environment; Goals; Growth; Instruction; Intervention; Joints; Knowledge; Language; Lead; Learning; Learning Disorders; Length; Measures; Mediating; Modeling; Nodal; Nursery Schools; Outcome; Output; Participant; Phase; Play; Prediction of Response to Therapy; Problem behavior; Public Health; Randomized; Reporting; Research; Research Personnel; Sequential Multiple Assignment Randomized Trial; Series; Site; Speech; Teaching Method; Testing; Training; Vocabulary; Voice; Work; adaptive intervention; autism spectrum disorder; autistic children; base; disability; effective intervention; elementary school; flexibility; follow-up; improved; innovation; input device; novel; peer; peer coaching; primary outcome; reinforcer; response; service providers; skills; social; social communication; social communication impairment; social inclusion; social interventions; social skills; statistics; teacher; treatment response; trial design; virtual vocal tract; vocalization

PROJECT SUMMARY Impaired social communication is a core feature of autism spectrum disorder (ASD). This proposal will evaluate a series of peer-mediated interventions for preschool-age children (3 to 6 years) with ASD and limited or no spoken language, using an innovative Sequential Multiple Assignment Randomized Trial (SMART) design. Available evidence supports the beneficial effects of peer-mediated interventions for improving social communication skills in children with ASD.1, 2 Peer-related social competence is vital to a wide range of child outcomes.3 Children who achieve positive peer interactions in preschool show improved social communication and fewer behavioral problems in elementary school.4 In spite of considerable early intervention efforts, approximately 30% of children with ASD remain minimally-verbal in kindergarten5, restricting participation in inclusive activities. Recent studies report improved communication between children with ASD and peers after a speech-generating device (SGD) is included in treatment.6-9 A repertoire of effective interventions that can be applied and modified is necessary to ensure optimal social communication outcomes when children do not make anticipated progress. A strength of the study is that these interventions can be adopted by community- based, early service providers. All participants will receive an adapted Stay-Play-Talk (SPT)7, 10-12 peer- mediated intervention that varies in active ingredients examined by the PI in preliminary studies. Now, with SMART designs, it is possible to test and identify alternative combinations of peer-mediated approaches, such as the addition of a SGD to improve social communication of children with ASD and complex communication needs.7, 8, 13 In the current proposal, 132 preschoolers with ASD (and N=264 peers without disabilities) will be initially randomized to SPT and SGD with spoken peer input only (SPT Basic; peers taught to model language) or SPT and SGD with augmented peer input in which peers are taught to model verbal responses while simultaneously selecting screen icons (SPT Plus; peers taught to use verbal language models concurrently with the SGD). Each child’s response to treatment after 5 weeks will determine that child’s next phase in the SMART design. Children showing a positive response will continue in their originally assigned group. Children who are slow responders after 5 weeks will be randomly assigned to receive added treatment components to improve peer-directed communication (either SPT Plus or SPT Advanced). SPT Advanced adds direct instruction strategies for the children with ASD (i.e., adult prompts, reinforcers, and teaching trials) shown to increase child vocalizations in SGD interventions.9, 14 The use of a SMART design extends our prior work by testing the systematic addition of selected peer-mediated strategies in combination with an SGD8 that allows for flexible application of interventions based on child response measured at important nodal points.15-17 We have assembled an outstanding team of highly qualified investigators with complementary skills in preschool assessment, language intervention, clinical trials, and statistics.

项目摘要 社交障碍是自闭症谱系障碍（ASD）的核心特征。该提案将评估 对患有ASD和有限或无ASD的学龄前儿童（3至6岁）进行一系列同伴介导的干预 口语，使用创新的顺序多分配随机试验（SMART）设计。 现有的证据支持同伴介导的干预措施对改善社会 自闭症儿童的沟通技巧1，2同伴相关的社会能力对广泛的儿童至关重要 结果。3在学龄前获得积极同伴互动的儿童表现出更好的社会沟通 小学的行为问题较少。4尽管有相当多的早期干预努力， 大约30%的ASD儿童在2015年仍然保持最低限度的语言能力，限制了他们参与 包容性活动。最近的研究报告说，自闭症儿童与同龄人之间的沟通得到了改善， 治疗中包括语音发生装置（SGD）。6 -9有效的干预措施， 应用和修改是必要的，以确保最佳的社会沟通结果时，儿童不 取得预期的进展。这项研究的一个优点是，这些干预措施可以被社区采用- 早期的服务提供商所有参与者都将获得一个经过改编的Stay-Play-Talk（SPT）7，10-12 peer- 在初步研究中PI检查的活性成分不同的介导干预。现在随着 SMART设计，有可能测试和识别同伴介导方法的替代组合，例如 作为SGD的补充，以改善ASD儿童的社会沟通和复杂的沟通 在目前的提案中，132名患有ASD的学龄前儿童（N=264名无残疾的同龄人）将被 最初随机分配至SPT和SGD，仅使用口头同伴输入（SPT基本;同伴学习建模语言） 或SPT和SGD与增强的同伴输入，其中同伴被教导模仿口头反应， 同时选择屏幕图标（SPT Plus;学习同时使用口头语言模型的同伴 的SGD）。每个孩子在5周后对治疗的反应将决定孩子在下一阶段的治疗。 智能设计。表现出积极反应的儿童将继续留在原来分配的小组。儿童 5周后为慢反应者的患者将被随机分配接受额外的治疗组分， 改进对等通信（SPT Plus或SPT Advanced）。SPT Advanced增加了直接 ASD儿童的教学策略（即，成人提示，验证和教学试验）显示， 在SGD干预中增加儿童发声。9，14 SMART设计的使用扩展了我们之前的工作， 测试选定的同行介导的策略与SGD 8相结合的系统性添加， 根据在重要节点测得的儿童反应情况灵活采取干预措施。 组建了一支优秀的高素质调查团队，在学前教育方面具有互补技能 评估，语言干预，临床试验和统计。