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; 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 社会交流受损是自闭症谱系障碍（ASD）的核心特征。该建议将评估 一系列对学龄前儿童的同行介导的干预措施（3至6岁），ASD和LIMING或没有 口语，使用创新的顺序多重分配随机试验（智能）设计。 现有证据支持同伴介导的干预措施对改善社会的有益影响 ASD的儿童的沟通技巧，2个与同伴有关的社会能力对于广泛的儿童至关重要 成果。3个在学龄前实现积极同伴互动的孩子表明社交交流的改善 小学中的行为问题更少。4尽管有早期干预工作，但 大约30％的ASD儿童在幼儿园中仍保持最低率，限制参与 包容性活动。最近的研究报告报告改善了ASD儿童和同伴之间的沟通 治疗中包括语音生成设备（SGD）。6-9有效干预措施的曲目 应用和修改是必要的，以确保儿童不在 取得预期的进展。该研究的优势在于，这些干预措施可以由社区采用 - 基于早期服务提供商。所有参与者都将获得适应性的住宿交谈（SPT）7，10-12同行 - 介导的干预措施在初步研究中由PI检查的活性成分有所不同。现在，与 智能设计，可以测试和确定同伴介导的方法的替代组合，例如 作为增加ASD和复杂沟通儿童社交沟通的SGD 需求。7、8、13在当前的提案中，有132名ASD的学龄前儿童（n = 264个无残疾同行）将是 最初仅使用口语同伴输入随机将SPT和SGD随机分配（SPT Basic;教授模型语言的同伴） 或SPT和SGD，具有增强的同行输入 类似地选择屏幕图标（SPT Plus；同伴教导同时使用语言模型 使用SGD）。每个孩子在5周后对治疗的反应将决定孩子在 智能设计。表现出积极反应的儿童将在最初分配的小组中继续进行。孩子们 在5周后，谁是缓慢的响应者 改善同行定向的通信（SPT Plus或SPT Advanced）。 SPT高级添加直接 ASD儿童的指导策略（即成人提示，增强剂和教学试验） 在SGD干预中增加儿童发声。9，14智能设计的使用扩展了我们先前的工作 测试选定的同行介导的策略的系统添加以及允许的SGD8结合 为了根据在重要的节点上测得的儿童反应的干预措施的灵活应用。15-17我们 已经组建了一支由高素质的调查员组成的杰出团队 评估，语言干预，临床试验和统计数据。