Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety
Completed · Not applicable
Conditions studied: Autism, Asperger's Syndrome, Pervasive Developmental Disorder Not Otherwise Specified, Generalized Anxiety Disorder, Social Phobia, Separation Anxiety Disorder, Obsessive-compulsive Disorder, Specific Phobia
In brief
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.
Key facts
- Study ID
- NCT01919970
- Run by
- University of South Florida
- People needed
- 32
- Starts
- 2013-08-01
- Expected to finish
- 2017-08-01
- Last updated by the study team
- 2019-06-14
Who can join
Age: 6 and older, up to 12. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Rothman Center for Neuropsychiatry — St. Petersburg, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.