Clinical trial NCT01919970: Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety
Official title: Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Asperger's Syndrome
Pervasive Developmental Disorder Not Otherwise Specified
Generalized Anxiety Disorder
Social Phobia
Separation Anxiety Disorder
Obsessive-compulsive Disorder
Specific Phobia
Keywords: Autism
Asperger's Syndrome
Pervasive Developmental Disorder Not Otherwise Specified
Treatment
Cognitive-behavioral therapy
Anxiety
Children
Therapy
Generalized Anxiety Disorder
Social Phobia
Separation Anxiety Disorder
Obsessive-compulsive Disorder
Specific Phobia
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 common and may cause substantial distress and impairment beyond that caused by the autism diagnosis. Many children with anxiety disorders, especially those on the autism spectrum, do not receive evidence based treatment, which has fueled the development and evaluation of cognitive-behavioral therapy (CBT). Accordingly, we are proposing a randomized controlled trial to examine the efficacy of exposure based CBT that heavily incorporates parents (EF-CBT) relative to a TAU condition (TAU) in 50 youth ages 6-12 years with ASD and comorbid anxiety disorder(s).

Eligibility criteria: 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 training, applied behavior analysis targeting anxiety). Those in the TAU arm will be able to seek out psychiatric/psychological services at their discretion.

Primary outcomes:
measure: Pediatric Anxiety Rating Scale
timeFrame: After an average of 12 weeks (post-treatment)
Secondary outcomes:
measure: Clinical Global Impression - Severity Scale
timeFrame: After an average of 12 weeks (Post-treatment)
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Rothman Center for Neuropsychiatry
state: Florida
Study officials:
References: