Status:
COMPLETED
Neural Mechanisms of CBT for Anxiety in Autism (Open Pilot Study)
Lead Sponsor:
Yale University
Conditions:
Autism
Autism Spectrum Disorder
Eligibility:
All Genders
8-14 years
Phase:
NA
Brief Summary
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, approx...
Eligibility Criteria
Inclusion
- Males and females, ages 8 to 14 inclusive.
- DSM-V diagnosis of autism spectrum disorder.
- DSM-V diagnosis of generalized anxiety disorder, separation anxiety disorder, or social phobia.
- Score \> 19 on the 20 Item Anxiety scale of the Child and Adolescent Symptom Inventory.
- Full Scale IQ and Verbal IQ \> 70.
- Unmedicated or on stable medication for irritability, ADHD, anxiety, or depression for at least 6 weeks, with no planned changes for duration of study.
- 7\. Subjects will be free of metal medical implants, and will have a body weight of less than 250 lbs. and no claustrophobia. \[These are necessitated by the safety requirements of the fMRI.\]
- 8\. Child is an English speaker.
- 9\. Child is able to meet fMRI data quality requirements at baseline \[to enable pre- to post-treatment comparison.\]
Exclusion
- Presence of a known serious medical condition in the child (based on medical history or parent report) that would interfere with child and parent's ability to participate in the study.
- Presence of a current psychiatric diagnosis in the child that would require alternative treatment (based on assessment by experienced study clinician).
- Previous treatment with four or more sessions of CBT for anxiety. -
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02225808
Start Date
August 1 2014
End Date
December 1 2016
Last Update
January 14 2020
Active Locations (1)
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1
Yale School of Medicine, Child Study Center
New Haven, Connecticut, United States, 06520