Treatment of Autism Symptoms in Children (TASC): Initial RCT with Active Control

儿童自闭症症状的治疗 (TASC)：主动控制的初始随机对照试验

• 批准号: 8297454
• 负责人: Jeffrey James Wood
• 金额: $ 38.5万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-15 至 2017-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8297454
• 关键词: Address; Affect; Aftercare; Age; American Psychological Association; Attention; Autacoids; Autistic Disorder; Behavior; Behavioral; Belief; Benchmarking; California; Caring; Centers for Disease Control and Prevention (U.S.); Characteristics; Child; Childhood; Clinical; Cognitive; Cognitive Therapy; Collaborations; Communities; Consumer Satisfaction; Diagnosis; Emotional; Evidence based treatment; Goals; Guidelines; Home environment; Impaired cognition; Individual; Intervention; Joints; Language Disorders; Literature; Los Angeles; Maintenance; Measures; Methods; Modality; Modeling; Outcome; Outcome Measure; Outpatients; Patients; Placebos; Population; Prevalence; Procedures; Public Health; Randomized; Randomized Controlled Trials; Relative (related person); Research; Research Design; Resistance; School-Age Population; Schools; Services; Severities; Social Environment; Strategic Planning; Symptoms; Syndrome; Techniques; Time; Treatment Efficacy; Treatment Protocols; Treatment outcome; Universities; Wood material; Work; Youth; active control; age group; aged; arm; autism spectrum disorder; base; behavior observation; efficacy testing; evidence base; flexibility; follow-up; functional disability; improved; intervention effect; meetings; memory retrieval; novel strategies; outcome forecast; peer; primary outcome; programs; psychosocial; response; satisfaction; semantic processing; skills training; social; social skills; standard of care; treatment effect

DESCRIPTION (provided by applicant): Autism spectrum disorders (ASDs) are among the most common childhood neurodevelopmental syndromes. A fundamental goal in the field is the discovery of methods that mitigate core autism symptoms. Greater severity of autism symptoms is associated with increased functional impairment, while lower levels of symptoms are associated with better prognosis. Core autism symptoms span from social-cognitive impairments, to pragmatic language deficits, to repetitive and rigid behaviors. The core symptoms tend to be stable and resistant to intervention. While behavioral and talk-based therapies are common for school-aged youth with ASD, with the average child using about $6,000 of outpatient services annually, the current evidence base is weak. Most treatments involve group-based social skills training, with limited external validity and durability of effect. No psychosocial treatment for core autism symptoms in school-aged children with ASD meets American Psychological Association guidelines for possible efficacy. Cognitive behavioral therapy (CBT) offers a novel approach for addressing core autism symptoms in higher functioning school-age youngsters. CBT has been successfully adapted to treat emotional problems in school-aged children with ASD (e.g., Wood et al., 2009a). Initial results suggest that CBT may also be promising for reducing core autism symptoms (Wood et al., 2009b; Drahota, Wood et al., 2011). The treatment is based on a contemporary model of memory retrieval competition, employing strategies for enhancing the retention of adaptive conceptual and behavioral responses and the suppression of idiosyncratic beliefs and behaviors in daily social contexts (e.g., school, home), emphasizing the use of deep semantic processing to enhance memory retrieval. We are proposing a randomized controlled trial to examine the efficacy of CBT relative to the standard of care in the community, social skills training (SST), in youngsters with ASD. The CBT program has been tailored over the last five years to the characteristics and clinical needs of high-functioning youth with ASD. In response to the 2009 Interagency Autism Coordinating Committee (IACC) Strategic Plan, a modular treatment approach is employed to personalize the intervention. The primary outcome measure is the Playground Observation of Peer Engagement scale, an independent evaluator-rated school playground observational measure of joint engagement, which is a psychometrically valid measure of core autism symptoms with established treatment sensitivity. The proposed research will (1) examine the short term efficacy of CBT relative to SST on autism symptom severity, (2) evaluate the durability of observed treatment gains in CBT responders, (3) cross-validate the ADOS, ADI-R, and SRS as measures of treatment outcome against the primary outcome measure (school observations of joint engagement), and (4) identify predictors of treatment outcome. A total of 80 youth (ages 7-12 years) with ASD will be randomly assigned to CBT or SST. Given the lack of evidence-based treatments for core autism symptoms in the school age-group, positive findings from this trial could have considerable public health significance. PUBLIC HEALTH RELEVANCE: Among youth with autism spectrum disorders (ASD), qualitatively lower levels of core autism symptoms are associated with a better prognosis. No psychosocial treatment for core autism symptoms in school-aged children with ASD meets American Psychological Association guidelines for possible efficacy, but CBT has shown promising results in our pilot work. This randomized, controlled trial will examine the efficacy of CBT relative to traditional social skills training (an attention placebo) in high-functioning schoo-aged youth with ASD in an effort to identify treatment protocols that can improve the prognosis of the rising number of children diagnosed with ASD.

描述（由申请人提供）：自闭症谱系障碍（ASD）是最常见的儿童神经发育综合征之一。该领域的一个基本目标是发现减轻核心自闭症症状的方法。更严重的自闭症症状与增加的功能障碍有关，而较低水平的症状与更好的预后有关。自闭症的核心症状包括社交认知障碍、语用语言缺陷、重复和刻板的行为。核心症状趋于稳定，对干预有抵抗力。虽然行为和基于谈话的治疗对于患有ASD的学龄青少年很常见，平均每个孩子每年使用约6，000美元的门诊服务，但目前的证据基础很薄弱。大多数治疗涉及基于群体的社会技能训练，其外部有效性和效果的持久性有限。没有心理社会治疗的核心自闭症症状的学龄儿童ASD符合美国心理协会的指导方针，可能的疗效。认知行为疗法（CBT）提供了一种新的方法来解决核心自闭症症状的高功能学龄儿童。CBT已成功地用于治疗患有ASD的学龄儿童的情绪问题（例如，Wood等人，2009年a）。初步结果表明，CBT也可能有希望减少核心自闭症症状（Wood et al.，2009 b; Drahota，Wood等人，2011年）。该治疗基于当代记忆检索竞争模型，采用增强适应性概念和行为反应的保留以及抑制日常社会环境中的特质信念和行为的策略（例如，学校，家庭），强调使用深层语义处理来增强记忆检索。我们提出了一项随机对照试验，以检查CBT相对于社区护理标准，社交技能训练（SST）在ASD青少年中的疗效。在过去的五年里，CBT计划一直针对ASD高功能青年的特点和临床需求而量身定制。为了响应2009年机构间自闭症协调委员会（IACC）战略计划，采用模块化治疗方法进行个性化干预。主要的结果测量是同伴参与量表的操场观察，这是一个独立的评估者评定的学校操场联合参与的观察措施，这是一个心理测量学上有效的衡量核心自闭症症状与既定的治疗敏感性。拟议的研究将（1）检查CBT相对于SST对自闭症症状严重程度的短期疗效，（2）评估CBT应答者中观察到的治疗收益的持久性，（3）交叉验证ADOS，ADI-R和SRS作为治疗结果的指标，对照主要结果指标（联合参与的学校观察），以及（4）确定治疗结果的预测因素。共有80名ASD青少年（7-12岁）将被随机分配到CBT或SST。鉴于缺乏对学龄儿童核心自闭症症状的循证治疗，这项试验的积极结果可能具有相当大的公共卫生意义。 公共卫生相关性：在患有自闭症谱系障碍（ASD）的青少年中，核心自闭症症状的定性水平较低与预后较好相关。对于患有ASD的学龄儿童的核心自闭症症状，没有心理社会治疗符合美国心理协会关于可能疗效的指南，但CBT在我们的试点工作中显示出有希望的结果。这项随机对照试验将检查 CBT相对于传统的社交技能训练（注意力安慰剂）在高功能学龄青少年ASD中的作用，旨在确定治疗方案，以改善越来越多的ASD儿童的预后。