Cognitive Behavioral Therapy for Anxiety Disorders in Adolescents With Autism

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

In brief

Due to the considerable prevalence of anxiety in youth with autism spectrum disorders, this study seeks to establish the efficacy of a modified cognitive behavioral therapy protocol in 50 adolescents versus other available treatment options.

Key facts

Study ID: NCT01563003
Run by: University of South Florida
People needed: 31
Starts: 2011-06-01
Expected to finish: 2015-04-01
Last updated by the study team: 2015-04-17

Who can join

Age: 11 and older, up to 16. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Outpatient children with an autism spectrum disorder (see #2 below) between the ages 11-16 years.
Meets criteria for a diagnosis of autism, Asperger syndrome (AS), or PDD-NOS using scores from the Autism Diagnostic Interview-Revised and the Childhood Autism Rating Scale.
Meets DSM-IV criteria for a diagnosis of one of the following anxiety disorders: separation anxiety disorder (SAD), generalized anxiety disorder (GAD), social phobia, or obsessive compulsive disorder (OCD) as determined by the ADIS-IV-C/P (with CSR 4) and all available information.
Minimum score of 13 on the PARS Severity Scale; this score indicates clinically significant anxiety symptom severity (RUPP, 2002) and has been used in recent major clinical trials (e.g., Walkup et al., 2008).
Child has a Full Scale and Verbal Comprehension IQ > 80 as assessed on a commonly used IQ test.
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 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative medications, nutritionals or therapeutic diets within 6 weeks of study enrollment.
Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 8 weeks before study enrollment (6 weeks for antipsychotic). Alternative medications that might have behavioral effects must be stable for 6 weeks prior to the study baseline assessment. Any medications that the adolescent is on must remain stable during treatment. If a potential participant is taking psychotropic medication at the time of the phone evaluation or the first in-person study assessment and wishes to discontinue this medication to enter the study, the patient will be asked to discuss this option with their prescribing physician to determine whether medication discontinuation would be safe and in the adolescent's best interest. In addition, we will obtain the patient's written consent to contact their treating clinician to determine the appropriateness of study participation. We will not influence the decision patients make with their prescribing physician. All pharmacotherapy recommendations will be made in consultation with Dr. Murphy.
(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.

Where it is running

Rothman Center for Neuropsychiatry — St. Petersburg, Florida, United States

Full record on ClinicalTrials.gov

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