Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety (NCT01919970) | Clinical Trial Compass
CompletedNot Applicable
Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety
United States32 participantsStarted 2013-08
Plain-language summary
Autism spectrum disorders affect as many as 1 out of 88 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. Accordingly, we are proposing a randomized controlled trial to examine the effectiveness of a form of cognitive-behavioral therapy relative to treatment as usual (TAU) in 50 youth ages 6-12 with autism spectrum disorders and comorbid anxiety.
Who can participate
Age range6 Years – 12 Years
SexALL
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Inclusion Criteria:
* Outpatient children with an autism spectrum disorder between the ages 6-12 years.
* Meets criteria for a diagnosis of one of the following anxiety disorders: generalized anxiety disorder, separation anxiety disorder, social phobia, specific phobia, panic disorder or obsessive-compulsive disorder.
* Minimum score of 12 on the Pediatric Anxiety Rating Scale - Severity Scale.
* Child has a Full Scale and Verbal Comprehension IQ \> 80.
Exclusion Criteria:
* Current clinically significant suicidality or engagement in suicidal behaviors within the last 6 months.
* Presence of any clinical features requiring a higher level of care (inpatient or partial hospital treatment).
* Any lifetime diagnosis (meeting DSM-IV criteria) of bipolar disorder, schizophrenia or schizoaffective disorder; or Substance abuse in the past 6 months.
* Initiation of an antidepressant medication within 10 weeks before study enrollment or an antipsychotic medication 6 weeks before study enrollment or the child has changed the dose of an established medication within 6 weeks before study enrollment (4 weeks for antipsychotic) or during psychotherapy (unless the dose is lowered because of side effects). If the child is on a medication, she or he can remain on it at its current dose. While in their treatment arm, children randomized to the EF-CBT condition will not be able to continue or initiate psychosocial interventions targeting anxiety(psychotherapy, certain types of social skills t…
What they're measuring
1
Pediatric Anxiety Rating Scale
Timeframe: After an average of 12 weeks (post-treatment)