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

NCT ID: NCT01187784

Last Updated: 2010-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-08-31

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.

Conditions

Autism Spectrum Disorder; Autism; Asperger Syndrome; PDD-NOS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CBT

Coping Cat cognitive-behavioral therapy protocol

Group Type: ACTIVE_COMPARATOR

Coping Cat cognitive-behavioral therapy for anxious youth

Intervention Type: BEHAVIORAL

Manualized, empirically supported CBT treatment for anxious youth

Waitlist Control

Treatment as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Coping Cat cognitive-behavioral therapy for anxious youth

Manualized, empirically supported CBT treatment for anxious youth

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Foundation for Autism Research

UNKNOWN

Sponsor Role: collaborator

Autism Society of America - San Diego Chapter

UNKNOWN

Sponsor Role: collaborator

Alliant International University

OTHER

Sponsor Role: lead

Responsible Party

Alliant International University

Principal Investigators

Rebecca McNally Keehn, M.A.

Role: PRINCIPAL_INVESTIGATOR

Alliant International University

Locations

Alliant International University

San Diego, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22588377 (View on PubMed)

Other Identifiers

McNallyKeehn

Identifier Type: -

Identifier Source: org_study_id