Yale School of Medicine, Child Study Center
New Haven, Connecticut, 06520, United States
NCT Number: NCT02225808
This is an open, pilot study of neural mechanisms of cognitive-behavioral therapy for anxiety in children with high-functioning autism spectrum disorder (ASD). In addition to the core symptoms, approximately forty percent of children with ASD exhibit clinically significant levels of anxiety. Cognitive-Behavioral Therapy (CBT) is a promising treatment for anxiety in children with high-functioning ASD, but the neural mechanisms of this treatment have not been studied. CBT teaches emotion regulation skills such as cognitive reappraisal, followed by behavioral exposure to anxiety-provoking situations. The investigators propose to investigate the neural mechanisms of CBT for anxiety by evaluating fMRI indices of socioemotional functioning before and after treatment in children, ages 8 to 14, with high-functioning ASD. Dysfunction of the amygdala and its connectivity with prefrontal cortex has been implicated in co-occurring ASD and anxiety. In the investigators research, compared to typically developing controls, children with ASD have shown lower activation in several regions of prefrontal cortex and a lack of down-regulation in the amygdala during a task of emotion regulation. Based on these observations, the investigators propose that a positive response to CBT for anxiety in children with ASD will be associated with increased activation of several regions in the prefrontal cortex as well as increased functional connectivity between prefrontal regions the amygdala during the task of emotion regulation. The primary aim of this pilot study is to examine the effects of CBT on the neural basis of anxiety in ASD by collecting fMRI data during emotion regulation, face perception, and rest before and after treatment. The investigators hypothesize that CBT will increase prefrontal activity, decrease amygdala reactivity, and enhance amygdala-prefrontal functional connectivity during emotion regulation. The investigators also hypothesize that CBT will decrease amygdala reactivity during perception of emotional faces. Additional analyses will be conducted to explore change in resting-state functional connectivity before and after CBT for anxiety in children with ASD.
Looking for future studies?
Notify Me8 year–14 year
All sexes
Interventional
Not applicable
New Haven, Connecticut, 06520, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: baseline (week 0)
fMRI scanning with tasks of emotion regulation and social perception
Time frame: endpoint (week 12)
fMRI scanning with tasks of emotion regulation and social perception
Time frame: baseline (week 0)
parent rating of child anxiety
Time frame: endpoint (week 12)
parent rating of child anxiety
Time frame: baseline (week 0)
clinician rating of anxiety based on an interview with parent and child
Time frame: endpoint (week 12)
clinician rating of anxiety based on an interview with parent and child
Yale University
Other
Neural Mechanisms of Cognitive-Behavioral Therapy for Anxiety in Children With Autism Spectrum Disorder: A Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06740760
ADHD - Attention Deficit Disorder With Hyperactivity, Anxiety
Stockholm, Sweden
View Trial DetailsNCT05588570
Anxiety, Anxiety Disorders
Charleston, South Carolina, United States
View Trial DetailsNCT06081348
22Q11 Deletion, 22q11 Deletion Syndrome
Calgary, Alberta, Canada
View Trial DetailsNCT06537128
Anxiety, Anxiety Disorders
Houston, Texas, United States
View Trial Details