Trial Purpose and Description
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. The aims of the study are to investigate the neural-systems-level targets of CBT for anxiety in children with ASD by evaluating brain indices of socio-emotional functioning with functional magnetic resonance imaging (fMRI) before and after treatment. 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. This HIC protocol was first approved on 12/12/2012 to conduct an open study of CBT for anxiety in children with autism. The purpose of the open study was to collect pilot data in preparation of the R01 application for a randomized controlled study. Our R01 has received a priority score in the 9th percentile and the program officer at the NICHD indicated that it is very likely to be funded. Thus, we are amending this HIC protocol to conduct a randomized study of CBT versus Psychoeducation and Supportive Therapy (PST) in children with high-functioning autism spectrum disorder (ASD). Please note that we refer to the pilot study as Study 1 and randomized study as Study 2.
Ages: 8 - 14 years
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)
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).
Yale University School of Medicine
Start Date: 05/11/2016
End Date: 06/30/2020
Last Updated: 02/22/2018
Study HIC#: 1211011144