CBT for Anxiety in Children With Autism
Completed · Not applicable
Conditions studied: Autism Spectrum Disorder, Anxiety
In brief
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.
Key facts
- Study ID
- NCT02725619
- Run by
- Yale University
- People needed
- 70
- Starts
- 2016-04-01
- Expected to finish
- 2022-10-12
- Last updated by the study team
- 2023-11-18
Who can join
Age: 8 and older, up to 14. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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).
Where it is running
- Yale Child Study Center — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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