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

描述（由申请人提供）：自闭症谱系障碍（ASDs）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。自闭症症状越严重，功能损害越严重，而症状越轻，预后越好。自闭症的核心症状包括社会认知障碍、语用障碍、重复和僵化的行为。核心症状趋于稳定，对干预有抵抗力。虽然行为疗法和谈话疗法在学龄自闭症青少年中很常见，平均每个孩子每年使用约6000美元的门诊服务，但目前的证据基础很薄弱。大多数治疗包括以团体为基础的社交技能训练，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符合美国心理协会指南的可能疗效。认知行为疗法（CBT）为解决高功能学龄儿童的核心自闭症症状提供了一种新的方法。CBT已被成功地用于治疗ASD学龄儿童的情绪问题（例如，Wood等人，2009a）。初步结果表明，CBT也有望减轻核心自闭症症状（Wood et al., 2009b; Drahota, Wood et al., 2011）。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在日常社会环境（如学校、家庭）中抑制特殊信念和行为的策略，强调使用深度语义处理来增强记忆检索。我们建议进行一项随机对照试验，以检验CBT相对于社区标准护理，社会技能训练（SST）对自闭症青少年的疗效。在过去的五年里，CBT项目是根据高功能自闭症青少年的特点和临床需求量身定制的。为响应2009年跨机构自闭症协调委员会（IACC）战略计划，采用模块化治疗方法进行个性化干预。主要结果测量是操场同伴参与观察量表，这是一种独立的评估者评定的学校操场联合参与观察量表，是一种心理测量学上有效的核心自闭症症状测量方法，具有既定的治疗敏感性。拟议的研究将(1)检验CBT相对于SST对自闭症症状严重程度的短期疗效，(2)评估CBT应答者观察到的治疗获益的持久性，(3)交叉验证ADOS、ADI-R和SRS作为治疗结果的测量指标，与主要结果测量指标（联合参与的学校观察）相比，(4)确定治疗结果的预测因子。共有80名青少年（7-12岁）自闭症患者将被随机分配到CBT或SST组。鉴于缺乏针对学龄期核心自闭症症状的循证治疗，这项试验的积极发现可能具有相当大的公共卫生意义。

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.