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Neural Mechanisms of CBT for Anxiety in Autism (Open Pilot Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02225808
Recruitment Status : Completed
First Posted : August 26, 2014
Last Update Posted : January 14, 2020
Information provided by (Responsible Party):
Yale University

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, 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.

Condition or disease Intervention/treatment Phase
Autism Autism Spectrum Disorder Anxiety Behavioral: CBT for anxiety in autism Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neural Mechanisms of Cognitive-Behavioral Therapy for Anxiety in Children With Autism Spectrum Disorder: A Pilot Study
Study Start Date : August 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CBT for anxiety in autism
Cognitive-behavioral therapy (CBT) teaches skills for coping with anxiety and consist of 12 weekly sessions. CBT is conducted with child and parent.
Behavioral: CBT for anxiety in autism

Primary Outcome Measures :
  1. functional magnetic resonance imaging (fMRI) [ Time Frame: baseline (week 0) ]
    fMRI scanning with tasks of emotion regulation and social perception

  2. functional magnetic resonance imaging (fMRI) [ Time Frame: endpoint (week 12) ]
    fMRI scanning with tasks of emotion regulation and social perception

Secondary Outcome Measures :
  1. Multidimensional anxiety scale for children (MASC) [ Time Frame: baseline (week 0) ]
    parent rating of child anxiety

  2. Multidimensional anxiety scale for children (MASC) [ Time Frame: endpoint (week 12) ]
    parent rating of child anxiety

  3. Pediatric Anxiety Rating Scale (PARS) [ Time Frame: baseline (week 0) ]
    clinician rating of anxiety based on an interview with parent and child

  4. Pediatric Anxiety Rating Scale (PARS) [ Time Frame: endpoint (week 12) ]
    clinician rating of anxiety based on an interview with parent and child

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Males and females, ages 8 to 14 inclusive.
  2. DSM-V diagnosis of autism spectrum disorder.
  3. DSM-V diagnosis of generalized anxiety disorder, separation anxiety disorder, or social phobia.
  4. Score > 19 on the 20 Item Anxiety scale of the Child and Adolescent Symptom Inventory.
  5. Full Scale IQ and Verbal IQ > 70.
  6. 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 Criteria:

  1. 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.
  2. Presence of a current psychiatric diagnosis in the child that would require alternative treatment (based on assessment by experienced study clinician).
  3. Previous treatment with four or more sessions of CBT for anxiety. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02225808

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United States, Connecticut
Yale School of Medicine, Child Study Center
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
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Principal Investigator: Denis Sukhodolsky, Ph.D. Yale University
Additional Information:
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Responsible Party: Yale University Identifier: NCT02225808    
Other Study ID Numbers: 1211011144
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Keywords provided by Yale University:
Additional relevant MeSH terms:
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Anxiety Disorders
Autistic Disorder
Autism Spectrum Disorder
Mental Disorders
Child Development Disorders, Pervasive
Neurodevelopmental Disorders