| Conditions: |
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Autism - Asperger's Syndrome - Generalized Anxiety Disorder - Social Phobia - Separation Anxiety Disorder - Obsessive-compulsive Disorder |
| Purpose: |
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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).
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
1. Outpatient children with an autism spectrum disorder (see #2 below) between the ages
7-11years.
2. Meets criteria for a diagnosis of autism, Asperger syndrome (AS), or PDD-NOS using
scores from the Autism Diagnostic Interview-Revised and Autism Diagnostic Observation
Schedule.
3. Meets DSM-IV criteria for a diagnosis of one of the following anxiety disorders:
separation anxiety disorder (SAD), generalized anxiety disorder (GAD), social phobia,
or obsessive compulsive disorder (OCD) as determined by the ADIS-IV-C/P (with CSR 4)
and all available information.
4. Minimum score of 14 on the PARS Severity Scale; this score indicates clinically
significant anxiety symptom severity (RUPP, 2002) and has been used in recent major
clinical trials (e.g., Walkup et al., 2008).
5. Child has a Full Scale and Verbal Comprehension IQ > 70 as assessed on a commonly
used IQ test.
6. Subjects with co-morbid depression, ADHD, tic disorder or disruptive behavior
disorders will be acceptable as long as the anxiety disorder is primary (i.e., most
impairing/distressing).
Exclusion Criteria:
1. Receiving concurrent psychotherapy, social skills training, or behavioral
interventions (e.g., applied behavior analysis). Families will have the option of
discontinuing such services to enroll in the study. Those randomized to TAU will be
able to continue or initiate psychosocial interventions (psychotherapy, social skills
training, applied behavior analysis, or family therapy) whereas those randomized to
CBT will not receive these interventions concurrent with CBT.
2. New Treatments: Initiation of an antidepressant within 12 weeks before study
enrollment or an antipsychotic 8 weeks before study enrollment. No new alternative
medications, nutritionals or therapeutic diets within 8 weeks of study enrollment.
3. Established Treatment changes: Any change in established psychotropic medication
(e.g., antidepressants, anxioloytics) within 8 weeks before study enrollment, or any
change in alternative medications that might have behavioral effects within 6 weeks
prior to the study baseline assessment. Those randomized to TAU may make medication
changes following randomization, including starting a medication; those randomized to
CBT will remain stable on medications during the study.
4. (a) Current clinically significant suicidality or (b) individuals who have engaged in
suicidal behaviors within 6 months will be excluded and referred for appropriate
clinical intervention.
5. Lifetime DSM-IV bipolar, schizophrenia or schizoaffective disorders; or Substance
abuse in past 6 months.
6. Unwillingness of parents to make the commitment to accompany their child for multiple
study visits.
7. Presence of a significant and/or unstable medical illness which might lead to
hospitalization during the study.
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| NCT ID: |
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NCT01178385 |
| Primary Contact: |
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Principal Investigator
Eric A Storch, Ph.D.
University of South Florida
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| Backup Contact: |
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N/A |
| Location Contact: |
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St. Petersburg, Florida 33701
United States
There is no listed contact information for this specific location.
Site Status: N/A |