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| Tracking Information | |||||||||
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| First Received Date ICMJE | May 13, 2009 | ||||||||
| Last Updated Date | July 7, 2009 | ||||||||
| Start Date ICMJE | April 2009 | ||||||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Cognitive Assessment Battery, including the NIMH-Measurement and Treatment Research to Improve Cognition in Schizophrenia (NIMH-MATRICS) Battery and the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) [ Time Frame: Measured at baseline and at 9 and 18 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00902798 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Functional Assessment Battery (Social, Role, Vocational) [ Time Frame: Measured at baseline and at 9 and 18 months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effectiveness of Cognitive Enhancement Therapy for Young Adults With Autism Spectrum Disorders | ||||||||
| Official Title ICMJE | Adapting Cognitive Enhancement Therapy for ASD | ||||||||
| Brief Summary | This study will test a therapy for improving thinking and brain function in people with autism, Asperger's syndrome, or pervasive developmental disorder. |
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| Detailed Description | Autism, Asperger's syndrome, and pervasive developmental disorder are all autism spectrum disorders (ASD), which are characterized by specific impairments in social interactions, communication, and imaginative play and by restricted and repetitive interests and behavior. These impairments stem from problems in underlying cognition and information processing. ASDs are often treated in childhood, but no attempt has been made to improve cognition and brain deficits in adults with ASDs, who often experience difficulty in understanding social situations, thinking abstractly, and taking the perspective of others. Cognitive enhancement therapy (CET) is a treatment that has proved effective in improving cognition in individuals with schizophrenia. This study will test whether CET can improve cognition and brain functioning in adults with ASDs. Participation in this study will last 18 months. Potential participants must be able to attend weekly treatment sessions in Pittsburgh, PA. The first 12 participants will be assigned to receive CET. All other participants will be randomly assigned to receive either CET or usual care as part of the control group. Some participants will also be randomly selected to complete a magnetic resonance imaging (MRI) assessment, which will involve performing tasks while undergoing a brain scan. Participants assigned to receive CET will complete three different weekly study visits: a group, an individual, and a computer visit. Participants will receive training in attention, memory, and problem solving abilities through computer training and will develop problem solving and communication skills through the group sessions. The CET treatment will require approximately 3 to 3.5 hours a week for up to 18 months. All participants will complete assessments at baseline and after 9 and 18 months. Assessments will include a cognitive testing session, in which participants complete a reading and intelligence test; an interview with a researcher, in which participants will be asked about the symptoms of their disorder; and an interview with a family member or close friend of the participant, which will involve questions about the participant's disorder. Participants assigned to MRI will undergo the procedure at baseline and 18 months. |
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| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Autistic Disorder | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 67 | ||||||||
| Estimated Completion Date | May 2014 | ||||||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 30 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00902798 | ||||||||
| Responsible Party | Allen A. DiPalma, Director of Research, University of Pittsburgh | ||||||||
| Study ID Numbers ICMJE | R21 MH085851, DDTR B2-MBA, GRANT00475979, NIH #1R21MH085851-01 | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | July 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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