School- and Home-Based Early Intervention for Toddlers With Autism
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First Received Date ICMJE | March 21, 2005 | ||||
Last Updated Date | May 20, 2011 | ||||
Start Date ICMJE | May 2003 | ||||
Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||
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Change History | Complete list of historical versions of study NCT00106210 on ClinicalTrials.gov Archive Site | ||||
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Descriptive Information | |||||
Brief Title ICMJE | School- and Home-Based Early Intervention for Toddlers With Autism | ||||
Official Title ICMJE | Early Detection, Intervention, and Neurobiology in Autism: Early Intervention Portion | ||||
Brief Summary | This study will determine the impact of early intervention on the communication and social development of toddlers with autism. |
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Detailed Description | Autism is a condition that affects brain development, often leading to difficulties in social, emotional, and educational functioning. This study will determine whether early intervention can improve such functioning in toddlers with autism. Each treatment session will last 6 months. Children with an autism spectrum disorder will be enrolled in one of two parallel classes and will receive one of two treatments 4 days a week for the duration of the session. Children in each class will receive the same amount and level of intervention, but with a different goal focus. Treatments will be school- and home-based; parents will receive instruction on administering the at-home part of the treatment. The intervention will include environmental engineering, developmental approaches, adaptations of traditional behavioral approaches, and contemporary behavioral approaches that apply principles of applied behavior analysis in more naturalistic teaching frameworks. A series of measures including scales, interviews, and observations will be used to assess the children at baseline, study completion, and 6 months after study completion. The children will be videotaped during the school-based intervention. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Intervention ICMJE |
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Publications * | |||||
* 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 | 50 | ||||
Completion Date | September 2007 | ||||
Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Months to 33 Months | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00106210 | ||||
Other Study ID Numbers ICMJE | U54 MH66417, DDTR BD-DD | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Rebecca Landa, Kennedy Krieger Institute | ||||
Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
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Investigators ICMJE |
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Information Provided By | National Institute of Mental Health (NIMH) | ||||
Verification Date | February 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |