Computer- Assisted Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders (CCAL)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 26, 2012 | ||||
| Last Updated Date | February 25, 2013 | ||||
| Start Date ICMJE | February 2012 | ||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pediatric Anxiety Rating Scale [ Time Frame: After an average of 12 weeks (Post-treatment) ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01565629 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Computer- Assisted Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders | ||||
| Official Title ICMJE | Computer- Assisted Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders | ||||
| Brief Summary | This study will examine the efficacy of a computerized cognitive behavioral therapy (CCBT) program for children with anxiety and autism spectrum disorders. |
||||
| Detailed Description | Many children who have an autism spectrum disorder (ASD) experience substantial anxiety that can cause impairment above that of an ASD alone. Few studies have examined effective treatment options for anxiety in this population.Preliminary studies have established the efficacy of computer-assisted cognitive behavioral therapy in otherwise typically developing youth with anxiety. Accordingly, this study seeks to examine the efficacy of computer assisted CBT in children with autism and ASD. A randomized-control trial will examine the ability of computer-assisted CBT to treat anxiety in comparison to a waitlist condition. This study will recruit approximately 40 youth ages 7-12 years. Significant reductions in anxiety severity and overall improvement of functioning will establish this treatment's ability to treat anxiety. This study aims to evaluate the acute efficacy of CCBT relative to WAITLIST in children with ASD and comorbid anxiety disorders;examine the short-term durability of treatment gains for youth receiving CCBT; examine whether, relative to WAITLIST, CCBT results in improved social; adaptive; and global functioning, as well as reduced child- and parent-rated anxiety symptoms; and examine whether, relative to WAITLIST, CCBT is associated with greater satisfaction and consumer acceptability. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Behavioral: 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 Names:
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | February 2014 | ||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 7 Years to 12 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01565629 | ||||
| Other Study ID Numbers ICMJE | CCAL-2012 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of South Florida | ||||
| Study Sponsor ICMJE | University of South Florida | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of South Florida | ||||
| Verification Date | February 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||