Trial record 14 of 506 for:    Autism

Neural Mechanisms of CBT for Anxiety in Autism

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT02225808
First received: August 19, 2014
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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 Intervention
Autism
Autism Spectrum Disorder
Anxiety
Behavioral: CBT for anxiety in autism

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neural Mechanisms of Cognitive-Behavioral Therapy for Anxiety in Children With Autism Spectrum Disorder: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • functional magnetic resonance imaging (fMRI) [ Time Frame: baseline (week 0) ] [ Designated as safety issue: No ]
    fMRI scanning with tasks of emotion regulation and social perception

  • functional magnetic resonance imaging (fMRI) [ Time Frame: endpoint (week 12) ] [ Designated as safety issue: No ]
    fMRI scanning with tasks of emotion regulation and social perception


Secondary Outcome Measures:
  • Multidimensional anxiety scale for children (MASC) [ Time Frame: baseline (week 0) ] [ Designated as safety issue: No ]
    parent rating of child anxiety

  • Multidimensional anxiety scale for children (MASC) [ Time Frame: endpoint (week 12) ] [ Designated as safety issue: No ]
    parent rating of child anxiety

  • Pediatric Anxiety Rating Scale (PARS) [ Time Frame: baseline (week 0) ] [ Designated as safety issue: No ]
    clinician rating of anxiety based on an interview with parent and child

  • Pediatric Anxiety Rating Scale (PARS) [ Time Frame: endpoint (week 12) ] [ Designated as safety issue: No ]
    clinician rating of anxiety based on an interview with parent and child


Estimated Enrollment: 10
Study Start Date: August 2014
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   8 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02225808

Contacts
Contact: Erin MacDonnell 203-737-3439 erin.macdonnell@yale.edu
Contact: Denis Sukhodolsky, Ph.D. 203-785-6446 denis.sukhodolsky@yale.edu

Locations
United States, Connecticut
Yale School of Medicine, Child Study Center Recruiting
New Haven, Connecticut, United States, 06520
Contact: Erin MacDonnell    203-737-3439    erin.macdonnell@yale.edu   
Principal Investigator: Denis Sukhodolsky, Ph.D.         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Denis Sukhodolsky, Ph.D. Yale University
  More Information

Additional Information:
Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02225808     History of Changes
Other Study ID Numbers: 1211011144
Study First Received: August 19, 2014
Last Updated: August 22, 2014
Health Authority: United States: Yale University Institutional Review Board

Keywords provided by Yale University:
CBT
autism
anxiety
treatment
fMRI

Additional relevant MeSH terms:
Anxiety Disorders
Child Development Disorders, Pervasive
Autistic Disorder
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014