3/3-Multisite RCT of Early Intervention for Spoken Communication in Autism

描述(由申请人提供)：这项研究补充了现有的NIH资助的研究方案，该方案专注于改善口语能力最低的学龄前儿童的口语结果(自闭症口语交流早期干预的多站点随机对照试验；1R01MH085048-01A1)，仅在肯尼迪·克里格研究所站点进行。这项拟议的研究是为了响应NIH NOT-DC-11-001的要求而设计的，NIH NOT-DC-11-001提供资金，以扩大现有研究方案的范围，以开发对患有自闭症的非语言学龄儿童的治疗的初步调查。这项拟议的研究目标是15名参与者，他们通过父母赠款完成了两项循证干预中的一项。尽管这15名儿童接受了为期6个月的强化干预，包括单独的试训(Lovaas等人，1981)或联合注意-象征性游戏(JASP；Kasari等人，2006)，但他们并没有成为功能性口语交际者。完成家长研究后，这些儿童将参加一项旨在改善表达能力交流发展的新型干预措施。新项目的具体目标是初步考察：(1)新的干预方案是否是改善自闭症学龄儿童表达交流发展和结果的积极因素；以及(2)家长和教师培训是否中介儿童在课堂和家庭中对表达交流技能的概括。探索性的目的是检查可能与治疗反应程度相关的治疗前变量，为计划对这一人群进行更大规模的干预研究提供信息。将使用非同步多基线研究设计，使我们能够在个体水平上检查这一异质性群体的变化轨迹和治疗反应(Lord，2010)。在基线阶段之后，所有参与者将在5个月内接受相同剂量的相同干预方案。在干预的特定时间点，教师将在课堂上进行培训，家长将在家里进行培训。新干预的积极成分包括培训儿童、教师和家长使用增强型和替代性交流(AAC)设备；轴心反应培训；基于计算机的接受性和表现性词汇和关系语义学培训；以及战略性选择的目标词汇和教学活动的使用，以最大限度地提高表达语言行为(自然言语或辅助语言)的灵活性。分析将包括目视检查和定量分析。这一补充资料将首次允许对先前循证干预的已知“无反应者”的新治疗进行评估。如果建议的干预措施被证明对因变量产生了影响，则将为一项随机临床试验奠定基础，该临床试验将适当地检查这组不同类型的非语言儿童的治疗反应的中介和调节因素。 与公共卫生相关：尽管接受了多年的干预，但许多自闭症儿童到了学龄儿童还没有获得使用口语进行功能性交流的能力。这项拟议的研究侧重于这样一组人，他们在接受了通过不同研究进行的两种干预之一后，没有发展出功能性言语。通过这个新项目，我们将研究一种新的干预方法的效果，旨在提高自闭症学龄儿童的表达交流能力。

DESCRIPTION (provided by applicant): This study supplements an existing NIH-funded research protocol that focuses on improving spoken language outcomes of preschoolers with minimal spoken language ability ("Multisite RCT of early intervention for spoken communication in autism"; 1R01MH085048-01A1) at the Kennedy Krieger Institute site only. The proposed study was designed in response to NIH NOT-DC-11-001, which provides funds to expand the scope of an existing research protocol to develop preliminary investigations into treatment of nonverbal school-aged children with autism. The proposed study targets 15 participants who completed one of two evidence-based interventions through the parent grant. Despite receiving a 6-month intensive intervention involving either Discrete Trial Training (Lovaas et al., 1981) or Joint Attention-Symbolic Play (JASP; Kasari et al., 2006), these 15 children did not become functional spoken language communicators. Upon completing the parent study, these children will be enrolled in a novel intervention aimed at improving expressive communication development. Specific aims of the new project are to preliminarily examine whether: (1) a novel intervention package is an active ingredient for improving expressive communication development and outcomes in nonverbal school-aged children with autism; and (2) parent and teacher training mediates children's generalization of expressive communication skills to the classroom and home. The exploratory aim is to examine pre-treatment variables that may be associated with degree of treatment response to inform planning for a larger-scale intervention study of this population. A nonconcurrent multiple baseline study design will be used, allowing us to examine trajectory of change and treatment response at the individual level for this heterogeneous group (Lord, 2010). After the baseline phase, all participants will receive the same intervention package at the same dosage for 5 months. At specified points in the intervention, teacher and parent training will occur in the classroom and home, respectively. Active ingredients in the novel intervention include training the children, teachers, and parents in the use of an augmentative and alternative communication (AAC) device; Pivotal Response Training; computer-based receptive and expressive lexical and relational semantics training; and strategically selected target vocabulary and use of instructional activities to maximize flexibility of expressive language behavior (natural speech or aided). Analyses will involve visual inspection and quantitative analyses. This supplement will permit, for the first time, assessment of a new treatment for known 'non-responders' to a prior evidence-based intervention. If the proposed intervention is shown to effect change on the dependent variables, the stage will be set for a randomized clinical trial powered appropriately to examine mediators and moderators of treatment response in this heterogeneous group of nonverbal children. PUBLIC HEALTH RELEVANCE: Many children with autism reach school age without having acquired functional communication abilities using spoken language despite having had years of intervention. The proposed study focuses on such a group who did not develop functional speech after receiving one of two interventions through a different study. Through this new project, we will study the effects of a novel approach to intervention aimed at improving the expressive communication abilities of nonverbal school-aged children with autism.