Computer- Assisted Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders

Completed · Not applicable

Conditions studied: Autism, Asperger's Syndrome, Generalized Anxiety Disorder, Social Phobia, Separation Anxiety Disorder, Obsessive-compulsive Disorder

In brief

This study will examine the efficacy of a computerized cognitive behavioral therapy (CCBT) program for children with anxiety and autism spectrum disorders.

Key facts

Study ID

NCT01565629

Run by

University of South Florida

People needed

40

Starts

2012-02-01

Expected to finish

2016-10-01

Last updated by the study team

2017-10-26

Who can join

Age: 7 and older, up to 12. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Outpatient children with an autism spectrum disorder (see #2 below) between the ages 7-12 years.
• Meets criteria for a diagnosis of an autism spectrum disorder using scores from the Autism Diagnostic Observation Schedule and Childhood Autism Rating Scale-II High Functioning Version.
• Meets DSM-IV criteria for a diagnosis of one of the following anxiety disorders: separation anxiety disorder (SAD), generalized anxiety disorder (GAD), social phobia, panic disorder or specific phobia as determined by the ADIS-IV-C/P (with CSR 4) and all available information.
• Minimum score of 12 on the PARS Severity Scale
• Child has a Full Scale and Verbal Comprehension IQ > 85 as assessed on the KBIT-2.
• 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).

You may not qualify if…

• 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.
• New Treatments: Initiation of an antidepressant within 10 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative medications, nutritionals or therapeutic diets within 8 weeks of study enrollment.
• Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 6 weeks before study enrollment, or any change in alternative medications that might have behavioral effects within 4 weeks prior to the study baseline assessment.
• (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.
• Lifetime DSM-IV bipolar, schizophrenia or schizoaffective disorders; or Substance abuse in past 6 months.
• Unwillingness of parents to make the commitment to accompany their child for multiple study visits.
• Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study or if the computer-assisted CBT is not a good avenue of treatment for the child.

Where it is running

• University of South Florida — St. Petersburg, Florida, United States

Full record on ClinicalTrials.gov

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