Neural Mechanisms of CBT for Anxiety in Children With Autism: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- blood oxygenation level dependent signal (BOLD) during down-regulation versus passive viewing of affective images.
研究概览
简要总结
This is a randomized controlled trial of Cognitive Behavioral Therapy (CBT) versus Psychoeducation and Supportive Therapy (PST) in children with Autism Spectrum Disorder and moderate to severe anxiety. The study will utilize fMRI to identify CBT-invoked changes in levels of activity/functional connectivity within the neural circuits involved in emotion regulation and social perception. Matched typically developing children without autism and/or anxiety will be scanned twice, 16 weeks apart, to enable interpretation of treatment-evoked change relative to normative development.
详细描述
Anxiety is among the most common concerns in children with autism spectrum disorder (ASD) who seek mental health services, causing suffering and family stress and exacerbating social disability. Cognitive-Behavioral Therapy (CBT) is a promising treatment for anxiety in children with high-functioning ASD, but the neural mechanisms supporting response to this treatment have not been studied. The neural-systems-level targets of CBT for anxiety in children with ASD will be investigated by evaluating brain indices of socio-emotional functioning with functional magnetic resonance imaging (fMRI) before and after treatment. CBT teaches emotion regulation skills, such as cognitive reappraisal, followed by behavioral exposure to anxiety-provoking situations. It is hypothesized that CBT aimed at the reduction of anxiety will enhance the neural circuitry that subserves the experience and regulation of emotions. This is a randomized controlled trial of CBT vs. Psychoeducation and Supportive Therapy (PST) in 100 school-age children with high-functioning ASD and moderate to severe anxiety. In addition, 50 matched typically-developing (TD) children will be scanned twice with a 16-week interval to enable interpretation of change in brain function in children with ASD after CBT vs. PST relative to TD children. CBT for anxiety will be provided using a structured manual that has been modified for children with ASD by increasing parental participation and addressing the role of core ASD symptoms in the experience and expression of anxiety. Subjects will be comprehensively characterized with regard to ASD diagnosis, IQ, adaptive behavior, and comorbid psychopathology. Functional MRI will be collected as the subjects perform tasks involving emotion regulation, emotional face perception, biological motion perception, and resting state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Boys and girls, ages 8 to 14 inclusive
- •Diagnosis of autism spectrum disorder
- •Diagnosis of anxiety disorder and clinically significant level of anxiety
- •Full scale IQ and Verbal IQ > 70
- •Unmedicated or on stable medication with no planned changes for duration of study
- •able to meet MRI safety (e.g., no metal medical implants) and data quality requirements (e.g., able to keep head still during scanning)
排除标准
- •Presence of a known serious medical condition that would interfere with participation in the study
- •Present of a current psychiatric disorder that requires immediate clinical attention
- •A previous adequate trial of CBT for anxiety within the past 2 years.
- •Note: This study will also recruit healthy volunteers (typically developing children without past or current mental health concerns).
结局指标
主要结局
blood oxygenation level dependent signal (BOLD) during down-regulation versus passive viewing of affective images.
时间窗: change from baseline (week 0) at endpoint (week 16)
During a Functional Magnetic Resonance Imaging (fMRI), subjects will view neutral and affect-inducing pictures selected to be appropriate for children. During the emotion regulation task, subjects are asked to either simply look at the pictures or to down-regulate their emotional reaction to the picture.
Pediatric Anxiety Rating Scale (PARS)
时间窗: change from baseline (week 0) at endpoint (week 16)
The PARS is a 50-item semi-structures interview of anxiety that will be conducted by an expert clinician. Endorsed symptoms are rated using 0-5 severity scale on 7 dimensions and a sum of scores for 5 of 7 dimensions constitute the total PARS score.
Clinical Global Impression - Improvement (CGI-I) scale
时间窗: change from baseline (week 0) at endpoint (week 16)
The CGI-I reflects the IE's assessment of overall change of the target symptoms from baseline on a scale from very much improved (score of 1) through no change (score of 4) to very much worse (score of 7). By convention, ratings of very much improved (score of 1) and much improved (score of 2) define positive response.
次要结局
- blood oxygenation level dependent signal (BOLD) during emotional face perception task(change from baseline (week 0) at endpoint (week 16))