Cognitive-Behavioral Therapy for Children With High-Functioning Autism Spectrum Disorder and Anxiety
Primary Purpose
Autism Spectrum Disorder, Autism, Asperger Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Coping Cat cognitive-behavioral therapy for anxious youth
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility 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
Sites / Locations
- Alliant International University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
CBT
Waitlist Control
Arm Description
Coping Cat cognitive-behavioral therapy protocol
Treatment as usual
Outcomes
Primary Outcome Measures
Anxiety Disorders Interview Schedule - Child/Parent Version
Scores on parent-administered anxiety diagnostic interview after treatment or waitlist.
Secondary Outcome Measures
Multidimensional Anxiety Scale for Children
Scores on self-report anxiety rating scale after treatment or waitlist.
Spence Children's Anxiety Scale (Child and Parent Versions)
Scores on self-and parent-report anxiety rating scale after treatment or waitlist.
Full Information
NCT ID
NCT01187784
First Posted
August 23, 2010
Last Updated
August 23, 2010
Sponsor
Alliant International University
Collaborators
National Foundation for Autism Research, Autism Society of America - San Diego Chapter
1. Study Identification
Unique Protocol Identification Number
NCT01187784
Brief Title
Cognitive-Behavioral Therapy for Children With High-Functioning Autism Spectrum Disorder and Anxiety
Official Title
Effectiveness of Cognitive-Behavioral Therapy for Children With High-Functioning Autism Spectrum Disorder and Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alliant International University
Collaborators
National Foundation for Autism Research, Autism Society of America - San Diego Chapter
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autism, Asperger Syndrome, PDD-NOS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT
Arm Type
Active Comparator
Arm Description
Coping Cat cognitive-behavioral therapy protocol
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Coping Cat cognitive-behavioral therapy for anxious youth
Intervention Description
Manualized, empirically supported CBT treatment for anxious youth
Primary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule - Child/Parent Version
Description
Scores on parent-administered anxiety diagnostic interview after treatment or waitlist.
Time Frame
Post Treatment (16 weeks)
Secondary Outcome Measure Information:
Title
Multidimensional Anxiety Scale for Children
Description
Scores on self-report anxiety rating scale after treatment or waitlist.
Time Frame
Post Treatment (16 weeks)
Title
Spence Children's Anxiety Scale (Child and Parent Versions)
Description
Scores on self-and parent-report anxiety rating scale after treatment or waitlist.
Time Frame
Post Treatment (16 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca McNally Keehn, M.A.
Organizational Affiliation
Alliant International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alliant International University
City
San Diego
State/Province
California
ZIP/Postal Code
92131
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22588377
Citation
McNally Keehn RH, Lincoln AJ, Brown MZ, Chavira DA. The Coping Cat program for children with anxiety and autism spectrum disorder: a pilot randomized controlled trial. J Autism Dev Disord. 2013 Jan;43(1):57-67. doi: 10.1007/s10803-012-1541-9.
Results Reference
derived
Learn more about this trial
Cognitive-Behavioral Therapy for Children With High-Functioning Autism Spectrum Disorder and Anxiety
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