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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
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.
Rothman Center for Neuropsychiatry, University of South Florida
St. Petersburg, Florida, United States
Pediatric Anxiety Rating Scale (Measures the Severity of Anxiety Symptoms)
This scale assesses the severity of anxiety symptoms. The scale ranges from 0 (minimum score) to 25 (maximum score). Higher scores reflect more severe anxiety symptoms; lower scores reflect lower anxiety severity. There are no subscales to this measure.
Time frame: After an average of 16 weeks (Post-treatment)
Anxiety Disorders Interview Schedule Highest Anxiety Clincian Severity Rating (Measures the Severity of the Child's Anxiety Symptoms)
This is a measure of severity of the child's primary anxiety disorder. The maximum rating is 8, the minimum rating is 0. Higher scores correspond to more severe anxiety.
Time frame: After an average of 16 weeks (Post-treatment)
Clinical Global Impression - Severity Scale (This Scale Measures the Severity of the Child's Anxiety Symptoms).
This scale measures severity of the child's overall anxiety presentation. The minimum rating is 0, the maximum is 6. Higher scores correspond to greater anxiety; lower scores correspond to less severe anxiety. There are no subscales for this measure.
Time frame: After an average of 16 weeks (Post-treatment)
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