2/3-Multisite RCT of Early Intervention for Spoken Communication in Autism

自闭症言语交流早期干预的 2/3 多站点随机对照试验

基本信息

批准号：
8064725
负责人：
TRISTRAM H SMITH
金额：
$ 39.23万
依托单位：
UNIVERSITY OF ROCHESTER
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-07-16 至 2014-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8064725
关键词：
3 year old 4 year old Address Adult Affect Age Agreement Area Arkansas Autistic Disorder Back Behavior Behavior Therapy Budgets California Canada Caregivers Characteristics Child Child Support Clinical Research Clinical Services Clinical Trials Data Monitoring Committees Code Cognitive Collaborations Communication Communities Consultations Controlled Study Data Data Analyses Data Quality Development Developmental Disabilities Diagnostic Discrimination Discrimination Learning Disease Documentation Early treatment Educational Intervention Educational process of instructing Educational workshop Effectiveness Enrollment Epidemiologic Studies Expectancy Faculty Family Family Characteristics Fostering Frequencies Funding Goals Home environment Hour Housing Impairment Individual Institutes Instruction Intervention Intervention Studies Interview Joints Language Language Development Language Development Disorders Lead Leadership Learning Letters Link Los Angeles Measures Mediating Mediator of activation protein Mental disorders Methods Modeling Monitor Multi-Institutional Clinical Trial NIH Program Announcements National Institute of Mental Health National Research Council Nature Norway Nursery Schools Organization and Administration Outcome Outcome Measure Parents Participant Pathologist Play Preschool Child Prevalence Principal Investigator Process Protocols documentation Psyche structure Psychological reinforcement Random Allocation Randomized Randomized Clinical Trials Randomized Controlled Clinical Trials Readiness Recording of previous events Recruitment Activity Research Research Infrastructure Research Personnel Research Project Grants Resources Safety Sampling Schedule Schools Site Social Interaction South Korea Speech Stimulus Stress Structure Study Subject Supervision Sweden Symptoms System Techniques Testing Training Treatment Factor Treatment outcome United States National Academy of Sciences Universities Work Writing aged authority autism spectrum disorder base comparative efficacy data management data sharing design distraction effective intervention experience flexibility graduate student human subject improved interest intervention effect intervention program joint attention meetings mental age novel operation primary outcome programs psychosocial quality assurance reinforcer response skills social social communication standard of care statistics sugar symposium task analysis teacher treatment program treatment response trial comparing working group

项目摘要

DESCRIPTION (provided by applicant): While significant progress has been made toward identifying effective interventions for preschool-age children with autism (National Research Council, 2001), few scientifically rigorous studies have compared active ingredients of these interventions or examined outcomes focused on core deficits. To address these areas of need, this collaborative, multi-site project combines the expertise of investigators experienced in randomized controlled clinical trials (RCTs), in the study of core deficits in young children with autism, and in data management and analysis of multi-site clinical trials. The goal of this project is to compare the efficacy of two interventions for improving spoken language and reducing symptoms of autism: (1) Discrete trial training (DTT)--an applied behavior analysis approach emphasizing highly structured teaching of school readiness skills (match-to-sample, imitation, functional play, and receptive and expressive language) and (2) Interpersonal developmental approach (IDA): a visually supported, child-focused, flexible engagement, socialcommunicative engagement approach on joint attention, symbolic play, and the use of conventional symbols within socially valid communicative contexts. Each site will recruit 64 children with autism (3-4 years of age; total sample=192) who are engaged in 25 hour per week early intervention programs. Children will be randomly assigned to DTT or IDA. In each condition, children's ongoing early intervention programs will be augmented with two 30-minute sessions daily of the study intervention (DTT or IDA) conducted by supervised therapists for 4 months, with transition to home therapy for 2 months. The primary aims are 1) to compare intervention conditions (DTT and IDA) on child outcomes of spoken language at the end of treatment and 6 months later, 2) to compare intervention conditions on child outcomes of core deficits of social features of autism at end of treatment and 6 months later, and 3) to examine potential moderators (e.g., mental age, language age) on treatment outcome. Secondary exploratory analyses focus on potential mediators (parent synchronization of joint attention and changes in parental expectancies), and non-specific factors (quality and quantity of community treatment). This study addresses multiple priorities in the autism research matrix (National Institute of Mental Health, 2004), including multisite RCTs of early intervention, isolation of active ingredients, identification of mediators or moderators, and treatment of core deficits.

描述（由申请人提供）：虽然在确定针对学龄前自闭症儿童的有效干预措施方面已经取得了重大进展（国家研究委员会，2001 年），但很少有科学严谨的研究比较这些干预措施的活性成分或检查针对核心缺陷的结果。为了解决这些领域的需求，这个协作的多地点项目结合了在随机对照临床试验（RCT）、自闭症幼儿核心缺陷研究以及多方面数据管理和分析方面经验丰富的研究人员的专业知识。现场临床试验。该项目的目标是比较两种干预措施在改善口语和减少自闭症症状方面的功效：（1）离散试验训练（DTT）——一种应用行为分析方法，强调高度结构化的学校准备技能教学（匹配-采样、模仿、功能性游戏以及接受性和表达性语言）和（2）人际发展方法（IDA）：一种视觉支持、以儿童为中心、灵活参与、关于共同关注、象征性的社会交流参与方法游戏，以及在社会有效的交流环境中使用传统符号。每个站点将招募 64 名自闭症儿童（3-4 岁；总样本 = 192），参与每周 25 小时的早期干预项目。孩子们将被随机分配到 DTT 或 IDA。在每种情况下，儿童正在进行的早期干预计划将通过监督治疗师进行为期 4 个月的每天两次 30 分钟的研究干预（DTT 或 IDA）课程来增强，并过渡到家庭治疗 2 个月。主要目的是 1) 比较干预条件（DTT 和 IDA）对治疗结束时和 6 个月后儿童口语结果的影响，2) 比较治疗结束时对自闭症社会特征核心缺陷儿童结果的干预条件治疗期间和 6 个月后，以及 3) 检查治疗结果的潜在调节因素（例如心理年龄、语言年龄）。二次探索性分析侧重于潜在的中介因素（父母共同关注的同步性和父母期望的变化）和非特定因素（社区治疗的质量和数量）。这项研究解决了自闭症研究矩阵中的多个优先事项（国家心理健康研究所，2004年），包括早期干预的多中心随机对照试验、活性成分的分离、调节剂或调节剂的识别以及核心缺陷的治疗。