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(ASD)是最常见的儿童神经发育综合征之一。该领域的一个根本目标是发现缓解自闭症核心症状的方法。自闭症症状越严重，功能损害越严重，而症状水平越低，预后越好。自闭症的核心症状从社会认知障碍，到语用语言缺陷，再到重复和僵化的行为。核心症状趋于稳定，不愿干预。虽然行为和谈话疗法在患有自闭症的学龄儿童中很常见，平均每个孩子每年使用约6000美元的门诊服务，但目前的证据基础薄弱。大多数治疗都涉及以团体为基础的社交技能培训，外部有效性和效果持久性有限。对患有自闭症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。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已经成功地用于治疗患有自闭症的学龄儿童的情绪问题(例如，Wood等人，2009a)。初步结果表明，CBT也可能在减少核心自闭症症状方面有希望(Wood等人，2009b；Drahota，Wood等人，2011年)。该治疗基于当代记忆提取竞赛模型，采用策略来增强对适应性概念和行为反应的保留，并抑制日常社会环境(如学校、家庭)中的特殊信念和行为，强调使用深层语义加工来增强记忆提取。我们正在提议一项随机对照试验，以检验CBT相对于社区护理标准--社交技能训练(SST)--在患有自闭症的青少年中的疗效。CBT计划在过去五年中针对患有ASD的高功能青年的特点和临床需求而量身定做。作为对2009年机构间自闭症协调委员会(IACC)战略计划的回应，采用了模块化治疗方法来个性化干预。主要结果衡量标准是同伴参与度量表的游乐场观察，这是一种由独立评估者评定的学校游乐场联合参与度观察衡量标准，是对核心自闭症症状的心理计量学有效衡量标准，具有既定的治疗敏感性。拟议的研究将(1)检验CBT相对于SST在自闭症症状严重性上的短期疗效，(2)评估CBT应答者观察到的治疗成果的持久性，(3)对照主要结果衡量标准(学校对联合参与的观察)交叉验证ADOS、ADI-R和SRS作为治疗结果的衡量标准，以及(4)确定治疗结果的预测因素。共有80名患有自闭症的青少年(7-12岁)将被随机分配到CBT或SST。鉴于缺乏对学龄组核心自闭症症状的循证治疗，这项试验的阳性结果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.