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

January 10, 2020 updated by: Yale University

Neural Mechanisms of Cognitive-Behavioral Therapy for Anxiety in Children With Autism Spectrum Disorder: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale School of Medicine, Child Study Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional magnetic resonance imaging (fMRI)
Time Frame: baseline (week 0)
fMRI scanning with tasks of emotion regulation and social perception
baseline (week 0)
functional magnetic resonance imaging (fMRI)
Time Frame: endpoint (week 12)
fMRI scanning with tasks of emotion regulation and social perception
endpoint (week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multidimensional anxiety scale for children (MASC)
Time Frame: baseline (week 0)
parent rating of child anxiety
baseline (week 0)
Multidimensional anxiety scale for children (MASC)
Time Frame: endpoint (week 12)
parent rating of child anxiety
endpoint (week 12)
Pediatric Anxiety Rating Scale (PARS)
Time Frame: baseline (week 0)
clinician rating of anxiety based on an interview with parent and child
baseline (week 0)
Pediatric Anxiety Rating Scale (PARS)
Time Frame: endpoint (week 12)
clinician rating of anxiety based on an interview with parent and child
endpoint (week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 22, 2014

First Posted (Estimate)

August 26, 2014

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1211011144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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