Skip to main content
OpenTrials
Completed

NCT Number: NCT02725619

CBT for Anxiety in Children With Autism

This is a randomized controlled trial of Cognitive Behavioral Therapy (CBT) versus Psychoeducation and Supportive Therapy (PST) in children with Autism Spectrum Disorder and moderate to severe anxiety. The study will utilize fMRI to identify CBT-invoked changes in levels of activity/functional connectivity within the neural circuits involved in emotion regulation and social perception. Matched typically developing children without autism and/or anxiety will be scanned twice, 16 weeks apart, to enable interpretation of treatment-evoked change relative to normative development.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Anxiety Anxiety Disorders Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Child Study Center

New Haven, Connecticut, 06520, United States

About this study

Anxiety is among the most common concerns in children with autism spectrum disorder (ASD) who seek mental health services, causing suffering and family stress and exacerbating social disability. Cognitive-Behavioral Therapy (CBT) is a promising treatment for anxiety in children with high-functioning ASD, but the neural mechanisms supporting response to this treatment have not been studied. The neural-systems-level targets of CBT for anxiety in children with ASD will be investigated by evaluating brain indices of socio-emotional functioning with functional magnetic resonance imaging (fMRI) before and after treatment. CBT teaches emotion regulation skills, such as cognitive reappraisal, followed by behavioral exposure to anxiety-provoking situations. It is hypothesized that CBT aimed at the reduction of anxiety will enhance the neural circuitry that subserves the experience and regulation of emotions. This is a randomized controlled trial of CBT vs. Psychoeducation and Supportive Therapy (PST) in 100 school-age children with high-functioning ASD and moderate to severe anxiety. In addition, 50 matched typically-developing (TD) children will be scanned twice with a 16-week interval to enable interpretation of change in brain function in children with ASD after CBT vs. PST relative to TD children. CBT for anxiety will be provided using a structured manual that has been modified for children with ASD by increasing parental participation and addressing the role of core ASD symptoms in the experience and expression of anxiety. Subjects will be comprehensively characterized with regard to ASD diagnosis, IQ, adaptive behavior, and comorbid psychopathology. Functional MRI will be collected as the subjects perform tasks involving emotion regulation, emotional face perception, biological motion perception, and resting state.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Boys and girls, ages 8 to 14 inclusive
  • Diagnosis of autism spectrum disorder
  • Diagnosis of anxiety disorder and clinically significant level of anxiety
  • Full scale IQ and Verbal IQ > 70
  • Unmedicated or on stable medication with no planned changes for duration of study
  • able to meet MRI safety (e.g., no metal medical implants) and data quality requirements (e.g., able to keep head still during scanning)

Exclusion criteria

  • Presence of a known serious medical condition that would interfere with participation in the study
  • Present of a current psychiatric disorder that requires immediate clinical attention
  • A previous adequate trial of CBT for anxiety within the past 2 years.

Note: This study will also recruit healthy volunteers (typically developing children without past or current mental health concerns).

Treatment and study plan

CBT

Behavioral

Other names: Behavior therapy

PST

Behavioral

Other names: Supportive psychotherapy

Primary outcomes

  1. Pediatric Anxiety Rating Scale (PARS)

    Time frame: change from baseline (week 0) at midpoint (week 8)

    The PARS is a 50-item semi-structures interview of anxiety that will be conducted by an expert clinician. Endorsed symptoms are rated using 0-5 severity scale on 7 dimensions and a sum of scores for 5 of 7 dimensions constitute the total PARS score.

  2. Pediatric Anxiety Rating Scale (PARS)

    Time frame: change from baseline (week 0) at endpoint (week 16)

    The PARS is a 50-item semi-structures interview of anxiety that will be conducted by an expert clinician. Endorsed symptoms are rated using 0-5 severity scale on 7 dimensions and a sum of scores for 5 of 7 dimensions constitute the total PARS score.

  3. Clinical Global Impression - Improvement (CGI-I) scale

    Time frame: change from baseline (week 0) at midpoint (week 8)

    The CGI-I reflects the IE's assessment of overall change of the target symptoms from baseline on a scale from very much improved (score of 1) through no change (score of 4) to very much worse (score of 7). By convention, ratings of very much improved (score of 1) and much improved (score of 2) define positive response.

  4. Clinical Global Impression - Improvement (CGI-I) scale

    Time frame: change from baseline (week 0) at endpoint (week 16)

    The CGI-I reflects the IE's assessment of overall change of the target symptoms from baseline on a scale from very much improved (score of 1) through no change (score of 4) to very much worse (score of 7). By convention, ratings of very much improved (score of 1) and much improved (score of 2) define positive response.

  5. blood oxygenation level dependent signal (BOLD) during down-regulation versus passive viewing of affective images.

    Time frame: change from baseline (week 0) at endpoint (week 16)

    During a Functional Magnetic Resonance Imaging (fMRI), subjects will view neutral and affect-inducing pictures selected to be appropriate for children. During the emotion regulation task, subjects are asked to either simply look at the pictures or to down-regulate their emotional reaction to the picture.

Secondary outcomes

  1. blood oxygenation level dependent signal (BOLD) during emotional face perception task

    Time frame: change from baseline (week 0) at endpoint (week 16)

    During a Functional Magnetic Resonance Imaging (fMRI), subjects will complete the emotional face perception task. This task involves subjects being asked to view and match emotional faces and geometrical shapes. During "match emotion" blocks, participants view a trio of angry, fearful, or neutral faces and match emotional expression of one of two faces to the target face.

Other outcomes

  1. blood oxygenation level dependent signal (BOLD) during perception of biological versus scrambled motion.

    Time frame: change from baseline (week 0) at endpoint (week 16)

    During a Functional Magnetic Resonance Imaging (fMRI), participants will perform the biological motion perception task. This task involves viewing coherent and scrambled point-light displays of biological motion created from motion capture data. The coherent motion displays feature an adult performing easily recognizable movements, such as playing pat-a-cake. The scrambled motion animations were created by randomly selecting 16 points from the biological motion displays and plotting their trajectories on a black background.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Neural Mechanisms of CBT for Anxiety in Children With Autism: Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2016
Registry last updated
Nov 18, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.