Schema, Emotion, and Behavior Therapy for Children (SEBASTIEN)
2018年9月5日 更新者:Jeffrey J. Wood、University of California, Los Angeles
Treatment of Autism Symptoms in Children (TASC): Initial RCT With Active Control
The study is a randomized controlled trial to examine the efficacy of individual cognitive behavioral therapy (CBT) relative to a standard community treatment, in youngsters with autism spectrum disorder (ASD).
The individual CBT program has been tailored over the last five years to the clinical needs of high-functioning youth with ASD.
研究概览
地位
完全的
条件
详细说明
Autism spectrum disorder (ASD) is among the most common childhood developmental disorders.
A key goal in the field is the discovery of methods that reduce core autism symptoms.
Core autism symptoms include social-cognitive impairments, pragmatic language deficits, and repetitive and rigid behaviors.
The core symptoms tend to be stable and resistant to intervention.
Most treatments involve group-based social skills training (SST), with limited effects.
No 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.
Initial results suggest that individual 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, emphasizing the use of deep semantic processing to enhance memory retrieval.
We are proposing a randomized controlled trial to examine the efficacy of individual CBT relative to a standard community treatment in youngsters with ASD.
研究类型
介入性
注册
70
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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California
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Los Angeles、California、美国、90024
- Jeffrey Wood
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
9年 至 13年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Meets research criteria for a diagnosis of autism, based on child scores on the ADI-R and ADOS tests.
- If taking medication, have maintained a stable dose for 1 month prior to baseline assessment.
- Between the ages of 9-13 years.
- The child's teacher consents to participate in the study to play a modest role in helping implement the intervention and facilitate the school observation assessment.
Exclusion Criteria:
- IQ less than 85.
- The child starts taking new medication(s) or current medication dose changes either (a) less than 1 month prior to the diagnostic evaluation, or (b) during the study period.
- The child is participating in an intensive early intervention program for autism such as applied behavior analysis or floortime.
- For any reason the child or parents appear unable to participate in the treatment program.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Individual Cognitive Behavioral Therapy
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Therapists will work with families for 32 weekly sessions, each lasting 90 minutes (45 minutes with the child and 45 minutes with the family/parents), implementing the CBT manual for children with ASD (Wood et al., 2007).
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有源比较器:Standard Community Treatment
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In this condition, the child meets with a therapist for 32 weekly sessions, each 90 minutes.
Therapists use an established manual to administer a standard community treatment.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Playground Observation of Peer Engagement scale
大体时间:Post-Treatment (week 32)
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An independent evaluator-rated school playground observational measure of joint engagement, which is a valid measure of core autism symptoms with established treatment sensitivity
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Post-Treatment (week 32)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Wood JJ, Kuhfeld M, Sturm A, Cai L, Wood KS, Cornejo Guevara MV, Galan CA, Johnson AR, Cho AC, Weisz JR. Personalized autism symptom assessment with the Youth Top Problems Scale: Observational and parent-report formats for clinical trials applications. Psychol Assess. 2022 Jan;34(1):43-57. doi: 10.1037/pas0001065. Epub 2021 Aug 30.
- Wood JJ, Sze Wood K, Chuen Cho A, Rosenau KA, Cornejo Guevara M, Galan C, Bazzano A, Zeldin AS, Hellemann G. Modular cognitive behavioral therapy for autism-related symptoms in children: A randomized controlled trial. J Consult Clin Psychol. 2021 Feb;89(2):110-125. doi: 10.1037/ccp0000621.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2012年3月1日
初级完成 (实际的)
2017年2月1日
研究完成 (实际的)
2017年9月1日
研究注册日期
首次提交
2012年3月23日
首先提交符合 QC 标准的
2013年2月1日
首次发布 (估计)
2013年2月5日
研究记录更新
最后更新发布 (实际的)
2018年9月7日
上次提交的符合 QC 标准的更新
2018年9月5日
最后验证
2018年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 11-002061
- 1R01MH094391-01A1 (美国 NIH 拨款/合同)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.