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Completed

NCT Number: NCT01187784

Cognitive-Behavioral Therapy for Children With High-Functioning Autism Spectrum Disorder and Anxiety

Many children and adolescents with autism spectrum disorder (ASD) experience high levels of anxiety which can further inhibit their ability to master developmental tasks such as succeeding in school and developing and maintaining friendships. Despite the need for effective treatments for children with ASD and anxiety, there have been few studies that have addressed this issue. Recently, preliminary evidence has supported the use of cognitive-behavioral therapy (CBT) to treat anxiety disorders in children with ASD.

This study will utilize a CBT treatment program called Coping Cat. Coping Cat has been found to be one of the most effective treatments for typically developing children with anxiety and has also been shown to be effective for treating anxiety in children with other disorders such as physical impairments, selective mutism, and Attention Deficit Hyperactivity Disorder. The investigators goal is to demonstrate that Coping Cat is an effective treatment for children with ASD and anxiety. Finding effective treatments for children with ASD and anxiety could increase adaptive social relationships, decrease stress among families, and prevent the maintenance of anxiety into adulthood.

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Key information

Conditions

Autism Spectrum Disorder Asperger Syndrome Autism Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders PDD-NOS

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alliant International University

San Diego, California, 92131, United States

About this study

The purpose of the current study is to evaluate the effectiveness of an empirically-supported, individually-based cognitive-behavioral treatment for anxiety disorders in children with autism spectrum disorder (ASD). Recent research suggests that 47 - 84% of children with ASD experience clinically significant levels of anxiety due to inhibited temperament, physiological hyperarousal, and distinct information processing biases. Despite the clear need for effective treatments for children with ASD and anxiety, there have been few empirical studies. However, a small body of literature has demonstrated growing support for the use of cognitive-behavioral therapy (CBT) to treat anxiety in children with high-functioning ASD. Kendall and Hedtke's Coping Cat cognitive-behavioral therapy program for anxious children will be utilized as the primary intervention. To date, there are no studies that have used this treatment program for anxiety in children with developmental disorders, including ASD. However, Coping Cat has been successfully adapted for children with a variety of co-occurring diagnoses (e.g., physical impairments, selective mutism). Participants in this study will be 20 children aged 7;0 to 14;11 years diagnosed with high-functioning ASD and at least one anxiety disorder (separation anxiety disorder, generalized anxiety disorder, or social phobia). A randomized controlled trial design will be employed. It is hypothesized that participants in the CBT condition will demonstrate a significantly larger reduction in overall levels of anxiety from pre-treatment to post-treatment compared to those in the waitlist (WL) condition and that children who complete the CBT treatment will maintain gains at two-month follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 7 - 14 years
  • Diagnosis of an autism spectrum disorder (meets DSM-IV criteria for autism, Asperger syndrome, or Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS))
  • Clinically significant anxiety (meets DSM-IV criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder)
  • IQ > 70
  • Primary spoken language: English

Exclusion criteria

  • IQ < 70
  • Comorbid psychotic disorder

Treatment and study plan

Coping Cat cognitive-behavioral therapy for anxious youth

Behavioral

Manualized, empirically supported CBT treatment for anxious youth

Primary outcomes

  1. Anxiety Disorders Interview Schedule - Child/Parent Version

    Time frame: Post Treatment (16 weeks)

    Scores on parent-administered anxiety diagnostic interview after treatment or waitlist.

Secondary outcomes

  1. Multidimensional Anxiety Scale for Children

    Time frame: Post Treatment (16 weeks)

    Scores on self-report anxiety rating scale after treatment or waitlist.

  2. Spence Children's Anxiety Scale (Child and Parent Versions)

    Time frame: Post Treatment (16 weeks)

    Scores on self-and parent-report anxiety rating scale after treatment or waitlist.

Sponsors and collaborators

Lead sponsor

Alliant International University

Other

Collaborators

  • Autism Society of America - San Diego Chapter
  • National Foundation for Autism Research

Registry information

Official study title

Effectiveness of Cognitive-Behavioral Therapy for Children With High-Functioning Autism Spectrum Disorder and Anxiety

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 24, 2010
Registry last updated
Aug 24, 2010

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.

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