CBT for Comorbid Anxiety Disorders in Children With Autism, Asperger Syndrome, or PDD-NOS
Condition: Autistic Disorder; Asperger Syndrome; Anxiety Disorders
MeSH terms: Syndrome; Anxiety Disorders; Autistic Disorder; Asperger Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to examine the efficacy of a cognitive behavioral therapy (CBT)
      program for treating anxiety symptoms, social problems, and adaptive behavior deficits in
      children with autism spectrum disorders.
    

Detailed description: 
      Anxiety disorders are commonly diagnosed in children with autism, Asperger syndrome (AS), and
      pervasive developmental disorder not otherwise specified (PDD-NOS). Anxiety disorders
      contribute to children's functional impairment over and above the functional deficits
      attributable to autism, AS, and PDD-NOS. Thus, investigators have called for the development
      of anxiety treatments for this population (Attwood, 2003). Cognitive behavioral therapy (CBT)
      has been found to be efficacious for anxiety disorders in typically developing children. This
      pilot study will advance the field by providing an estimate of the treatment effects of CBT
      for anxiety disorders among children with autism, AS, or PDD-NOS. The sample will include 20
      children aged 7-11 years with autism, AS, or PDD-NOS and a comorbid anxiety disorder.
      Children will be randomly assigned to immediate treatment or a 3-month waitlist. The
      manualized CBT program includes traditional anxiety treatment components including coping
      skills training (e.g., cognitive restructuring), in vivo exposure, operant procedures, and
      parent training. Additional treatment components have been added to enhance intervention
      response in children with AS or PDD-NOS, including emotion education, social
      skills/friendship skills training, and peer tutoring/mentoring modules. Trained graduate
      students with expertise in CBT and developmental disabilities will serve as therapists.
      Treatment fidelity will be checked using a session-by-session adherence checklist. Treatment
      acceptability and consumer satisfaction will be assessed at posttreatment, providing guidance
      on the extent to which the manual will need to be revised. Multiple measures of children's
      anxiety, including a structured diagnostic interview administered by an independent
      evaluator, will comprise the primary outcomes. Children's social functioning, adaptive
      behavior, and service use will also be assessed to determine if CBT can affect relevant
      distal outcomes. By comparing outcomes for children in the immediate treatment group versus
      those in the waitlist group, we will estimate effect sizes of CBT for this population.
      Subsequently, power analyses will be conducted in planning for a larger clinical trial. This
      study could contribute to public health efforts to address the mental health needs of the
      rising number of children diagnosed with autism-spectrum disorders. If CBT is found to be
      efficacious, it will be the first evidence-based psychological treatment to be successfully
      adapted for children with autism, AS, and PDD-NOS.
    

Intervention name(s): Cognitive-behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): Cognitive behavioral therapy for children with autism and anxiety.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment