Status:
COMPLETED
Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety
Lead Sponsor:
University of South Florida
Conditions:
Autism
Asperger's Syndrome
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief 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 co...
Detailed Description
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 co...
Eligibility Criteria
Inclusion
- 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
- 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 training, applied behavior analysis targeting anxiety). Those in the TAU arm will be able to seek out psychiatric/psychological services at their discretion.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01919970
Start Date
August 1 2013
End Date
August 1 2017
Last Update
June 14 2019
Active Locations (1)
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1
Rothman Center for Neuropsychiatry
St. Petersburg, Florida, United States, 33701