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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187784
• Other study ID #: McNallyKeehn
• Status: Completed
• Phase: Phase 1
• First received: August 23, 2010
• Last updated: August 23, 2010
• Start date: May 2009
• Est. completion date: August 2010

Study information

• Verified date: August 2010
• Source: Alliant International University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Coping Cat cognitive-behavioral therapy for anxious youth
Manualized, empirically supported CBT treatment for anxious youth

Locations

Country	Name	City	State
United States	Alliant International University	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Alliant International University	Autism Society of America - San Diego Chapter, National Foundation for Autism Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Disorders Interview Schedule - Child/Parent Version	Scores on parent-administered anxiety diagnostic interview after treatment or waitlist.	Post Treatment (16 weeks)	No
Secondary	Multidimensional Anxiety Scale for Children	Scores on self-report anxiety rating scale after treatment or waitlist.	Post Treatment (16 weeks)	No
Secondary	Spence Children's Anxiety Scale (Child and Parent Versions)	Scores on self-and parent-report anxiety rating scale after treatment or waitlist.	Post Treatment (16 weeks)	No