Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders
Condition: Autism; Asperger's Syndrome; Generalized Anxiety Disorder; Social Phobia; Separation Anxiety Disorder; Obsessive-compulsive Disorder
MeSH terms: Anxiety Disorders; Autistic Disorder; Autism Spectrum Disorder; Obsessive-Compulsive Disorder; Phobia, Social; Asperger Syndrome; Anxiety, Separation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Autism spectrum disorders affect as many as 1 out of 150 children and are related to
      significant impairment in social, adaptive, and school functioning. Co-occurring conditions,
      such as anxiety, are common and may cause substantial distress and impairment beyond that
      caused by the autism diagnosis. Although effective interventions have been developed for
      typically developing youth with anxiety disorders, this approach needs to be adapted for
      children with autism. Accordingly, we are proposing a randomized controlled trial to examine
      the effectiveness of CBT relative to treatment as usual (TAU) in 46 youth ages 7-11 with
      autism spectrum disorders and comorbid anxiety disorder(s).
    

Detailed description: 
      Autism spectrum disorders affect as many as 1 out of 150 children (Centers for Disease
      Control, 2007), with many higher-functioning children not being diagnosed until elementary
      school or later (Fombonne, 2003). Significant impairment in social, adaptive, and school
      functioning is prevalent and longstanding (Howlin et al., 2004). In addition, comorbid
      psychological disorders are common in the ASD population (Simonoff et al., 2008), and may
      cause substantial distress and impairment beyond that caused by the ASD diagnosis. Comorbid
      anxiety disorders, in particular, affect as many as 80% of children and adolescents with ASD
      (Bellini, 2004; de Bruin et al., 2007; Klin et al., 2005; Muris et al., 1998). Although
      efficacious interventions have been developed for otherwise typically developing youth with
      anxiety disorders, the linguistic; cognitive; and social characteristics of ASD may render
      standard treatment approaches less effective for children with ASD (Volkmar & Klin, 2000).
      Thus, there is a clinical need for the modification of existing treatment modalities for this
      unique group. To date, few studies have experimentally tested the efficacy of CBT for youth
      with a comorbid presentation of anxiety and ASD. This gap in the literature is of particular
      concern given the prevalence of comorbid anxiety among children, consequences of untreated
      anxiety, unknown efficacy of antidepressant medication for anxiety in ASD, and potential
      safety and tolerability issues related to medication use. Accordingly, we are proposing a
      randomized controlled trial to examine the efficacy of CBT relative to treatment as usual
      (TAU) in 46 youth ages 7-11 with ASD and comorbid anxiety disorder(s). In the proposed grant,
      we will: (1) examine the acute efficacy of CBT relative to TAU, and (2) evaluate the
      short-term maintenance of treatment gains. Forty-six children (ages 7-11 years) with ASD and
      comorbid anxiety disorder(s) will be randomly assigned to one of the two treatment
      conditions. Primary outcomes will be assessed by an independent evaluator, and will include
      change in anxiety symptom severity; response rates; and remission rates. Considering the
      rising number of children diagnosed with ASD, our proposed work toward the advent of an
      efficacious CBT protocol will provide a timely contribution to public health efforts.
    

Intervention name(s): Cognitive-behavioral therapy; Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.; Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Other intervention name(s): psychotherapy; counseling; therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Asperger's Syndrome; Treatment; Cognitive-behavioral therapy; Anxiety; Children; Therapy