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: 8811156
• 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 2016-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8811156
• 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; behavioral response; efficacy testing; evidence base; flexibility; follow-up; functional disability; improved; individualized medicine; intervention effect; meetings; memory retrieval; novel strategies; outcome forecast; peer; personalized intervention; 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.

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自闭症核心症状的方法。自闭症症状越严重，功能障碍就越严重，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、实用语言缺陷、重复和僵化行为。核心症状趋于稳定且难以干预。虽然基于行为和谈话的治疗对于患有 ASD 的学龄青少年来说很常见，平均每个孩子每年使用约 6,000 美元的门诊服务，但目前的证据基础薄弱。大多数治疗涉及基于小组的社交技能训练，外部有效性和效果的持久性有限。对于患有自闭症谱系障碍的学龄儿童的核心自闭症症状，没有一种心理社会治疗方法符合美国心理学会关于可能疗效的指南。认知行为疗法（CBT）为解决功能较高的学龄青少年的核心自闭症症状提供了一种新方法。 CBT 已成功用于治疗患有 ASD 的学龄儿童的情绪问题（例如，Wood 等人，2009a）。初步结果表明，CBT 也可能有望减少自闭症核心症状（Wood 等人，2009b；Drahota、Wood 等人，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抑制日常社会环境（例如学校、家庭）中特殊信念和行为的策略，强调使用深层语义处理来增强记忆检索。我们提议进行一项随机对照试验，以检验 CBT 相对于社区护理标准、社交技能培训 (SST) 对自闭症谱系障碍 (ASD) 青少年的疗效。 CBT 计划在过去五年中根据患有自闭症谱系障碍的高功能青少年的特征和临床需求量身定制。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来个性化干预。主要结果指标是同伴参与度的游乐场观察量表，这是一种独立评估者评定的学校操场联合参与观察指标，是对自闭症核心症状的心理测量有效指标，具有既定的治疗敏感性。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 应答者观察到的治疗效果的持久性，（3）根据主要结果指标（学校对共同参与的观察）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。总共 80 名患有 ASD 的青少年（7-12 岁）将被随机分配接受 CBT 或 SST。鉴于学龄组的核心自闭症症状缺乏循证治疗，这项试验的积极结果可能具有相当大的公共卫生意义。