Computer- Assisted Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders
NCT ID: NCT01565629
Last Updated: 2017-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2012-02-29
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Waitlist Condition
Children in this condition will withhold from any type of intervention for a period of 12 weeks.
No interventions assigned to this group
Computer Assisted CBT
Those who choose to participate will be required to attend 4 assessments - pre-treatment (week 0), mid-treatment (week 8), post-treatment, and a 4th assessment for a 3 month Follow-up. All children regardless of condition will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
Computer assisted cognitive behavioral therapy.
Those who choose to participate will be required to attend 4 assessments - pre-treatment (week 0), mid-treatment (week 8), post-treatment, and a 4th assessment for a 3 month Follow-up. All children regardless of condition will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
Interventions
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Computer assisted cognitive behavioral therapy.
Those who choose to participate will be required to attend 4 assessments - pre-treatment (week 0), mid-treatment (week 8), post-treatment, and a 4th assessment for a 3 month Follow-up. All children regardless of condition will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. Minimum score of 12 on the PARS Severity Scale
5. Child has a Full Scale and Verbal Comprehension IQ \> 85 as assessed on the KBIT-2.
6. 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).
Exclusion Criteria
2. 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.
3. 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.
4. (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.
5. Lifetime DSM-IV bipolar, schizophrenia or schizoaffective disorders; or Substance abuse in past 6 months.
6. Unwillingness of parents to make the commitment to accompany their child for multiple study visits.
7. 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.
7 Years
12 Years
ALL
Yes
Sponsors
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University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Eric A Storch, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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University of South Florida
St. Petersburg, Florida, United States
Countries
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Related Links
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Rothman Center for Pediatric Neuropsychiatry
Other Identifiers
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CCAL-2012
Identifier Type: -
Identifier Source: org_study_id