Clinical trial NCT02725619: CBT for Anxiety in Children With Autism
Official title: Neural Mechanisms of CBT for Anxiety in Children With Autism: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Anxiety
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-04-01
Enrollment: 70
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Pediatric Anxiety Rating Scale (PARS)
timeFrame: change from baseline (week 0) at midpoint (week 8)
measure: Pediatric Anxiety Rating Scale (PARS)
timeFrame: change from baseline (week 0) at endpoint (week 16)
measure: Clinical Global Impression - Improvement (CGI-I) scale
timeFrame: change from baseline (week 0) at midpoint (week 8)
measure: Clinical Global Impression - Improvement (CGI-I) scale
timeFrame: change from baseline (week 0) at endpoint (week 16)
measure: blood oxygenation level dependent signal (BOLD) during down-regulation versus passive viewing of affective images.
timeFrame: change from baseline (week 0) at endpoint (week 16)
Secondary outcomes:
measure: blood oxygenation level dependent signal (BOLD) during emotional face perception task
timeFrame: change from baseline (week 0) at endpoint (week 16)
Other outcomes:
measure: blood oxygenation level dependent signal (BOLD) during perception of biological versus scrambled motion.
timeFrame: change from baseline (week 0) at endpoint (week 16)
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
References:
citation: Sukhodolsky DG, Bloch MH, Panza KE, Reichow B. Cognitive-behavioral therapy for anxiety in children with high-functioning autism: a meta-analysis. Pediatrics. 2013 Nov;132(5):e1341-50. doi: 10.1542/peds.2013-1193. Epub 2013 Oct 28.
citation: Sukhodolsky DG, Scahill L, Gadow KD, Arnold LE, Aman MG, McDougle CJ, McCracken JT, Tierney E, Williams White S, Lecavalier L, Vitiello B. Parent-rated anxiety symptoms in children with pervasive developmental disorders: frequency and association with core autism symptoms and cognitive functioning. J Abnorm Child Psychol. 2008 Jan;36(1):117-28. doi: 10.1007/s10802-007-9165-9. Epub 2007 Aug 3.