CBT for Anxiety in Children With Autism



Status:Recruiting
Conditions:Anxiety, Neurology, Psychiatric, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:8 - 14
Updated:1/11/2018
Start Date:April 2016
End Date:November 2020

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Neural Mechanisms of CBT for Anxiety in Children With Autism: Randomized Controlled Trial

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.

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.

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).
We found this trial at
1
site
New Haven, Connecticut 06520
Phone: 203-785-6446
?
mi
from
New Haven, CT
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