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

This study has been completed.
Sponsor:
Collaborators:
National Foundation for Autism Research
Autism Society of America - San Diego Chapter
Information provided by:
Alliant International University
ClinicalTrials.gov Identifier:
NCT01187784
First received: August 23, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Autism Spectrum Disorder
Autism
Asperger Syndrome
PDD-NOS
Behavioral: Coping Cat cognitive-behavioral therapy for anxious youth
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Cognitive-Behavioral Therapy for Children With High-Functioning Autism Spectrum Disorder and Anxiety

Resource links provided by NLM:


Further study details as provided by Alliant International University:

Primary Outcome Measures:
  • Anxiety Disorders Interview Schedule - Child/Parent Version [ Time Frame: Post Treatment (16 weeks) ] [ Designated as safety issue: No ]
    Scores on parent-administered anxiety diagnostic interview after treatment or waitlist.


Secondary Outcome Measures:
  • Multidimensional Anxiety Scale for Children [ Time Frame: Post Treatment (16 weeks) ] [ Designated as safety issue: No ]
    Scores on self-report anxiety rating scale after treatment or waitlist.

  • Spence Children's Anxiety Scale (Child and Parent Versions) [ Time Frame: Post Treatment (16 weeks) ] [ Designated as safety issue: No ]
    Scores on self-and parent-report anxiety rating scale after treatment or waitlist.


Enrollment: 22
Study Start Date: May 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CBT
Coping Cat cognitive-behavioral therapy protocol
Behavioral: Coping Cat cognitive-behavioral therapy for anxious youth
Manualized, empirically supported CBT treatment for anxious youth
No Intervention: Waitlist Control
Treatment as usual

Detailed 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.

  Eligibility

Ages Eligible for Study:   7 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01187784

Locations
United States, California
Alliant International University
San Diego, California, United States, 92131
Sponsors and Collaborators
Alliant International University
National Foundation for Autism Research
Autism Society of America - San Diego Chapter
Investigators
Principal Investigator: Rebecca McNally Keehn, M.A. Alliant International University
  More Information

No publications provided by Alliant International University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rebecca McNally Keehn, M.A., Alliant International University
ClinicalTrials.gov Identifier: NCT01187784     History of Changes
Other Study ID Numbers: McNallyKeehn
Study First Received: August 23, 2010
Last Updated: August 23, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 24, 2014