Relationship Training for Children With Autism and Their Peers
| Tracking Information | |||||
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| First Received Date ICMJE | November 4, 2004 | ||||
| Last Updated Date | May 13, 2013 | ||||
| Start Date ICMJE | September 2003 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Social network involvement of autistic children [ Time Frame: Measured before and after treatment and at 3-month follow-up ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Social network involvement of autistic children | ||||
| Change History | Complete list of historical versions of study NCT00095420 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Relationship Training for Children With Autism and Their Peers | ||||
| Official Title ICMJE | Peer Related School Interventions in Autism | ||||
| Brief Summary | This study will determine whether peer interaction training interventions are effective in enhancing the social relationships of children with autism. |
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| Detailed Description | Children with autism often have poor relationships with other children during their childhood and through their adult lives. A number of peer-related intervention models have been developed, but these models have not been thoroughly reviewed or implemented within the school setting. This study will examine the social inclusion of children with autism, following different peer-related interventions training children with autism and their peers. Children will be randomly assigned to one of four interventions that comprise all autistic children, all nonautistic children, or a mixed group of both. The first intervention focuses on improving the social skills of autistic children. The second intervention involves educating the peers of autistic children to increase their acceptance of their autistic peers. The third intervention is a combination of the first two interventions. Children assigned to the fourth intervention will receive the usual training offered in their local school districts. Training for each group will be conducted twice a week for 6 weeks. Characteristics of the autistic child will be assessed through an interview that evaluates intelligence quotient (IQ), language skills, and social interaction. Teachers will be asked to complete a questionnaire describing the autistic child and his or her interaction with peers. The autistic children will complete a friendship survey, clinical global impressions scales, and a battery of neuropsychiatric tests. All assessments will be conducted at study start and again at study completion. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria for Autistic and Nonautistic Participants:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years to 11 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 | NCT00095420 | ||||
| Other Study ID Numbers ICMJE | U54 MH68172, U54MH068172, DDTR BD-DD | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Connie Kasari, Ph.D., University of California, Los Angeles | ||||
| Study Sponsor ICMJE | University of California, Los Angeles | ||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Los Angeles | ||||
| Verification Date | May 2013 | ||||
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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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