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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00090415 |
Purpose
This study will identify factors that distinguish children with autism from children with developmental delay and those with normal development and study the efficacy of intensive behavioral therapy in children with autism.
| Condition | Intervention | Phase |
|---|---|---|
|
Autism Autistic Disorder |
Behavioral: Intensive behavioral therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | UW STAART Center of Excellence |
| Estimated Enrollment: | 48 |
| Study Start Date: | April 2003 |
| Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Child participants with autism will undergo intensive behavioral therapy.
|
Behavioral: Intensive behavioral therapy
Participants will undergo a magnetic resonance imaging (MRI) scan and will complete various activities to determine brain functioning. In addition, children with autism will take part in intensive behavioral therapy at least 4 hours every day for the duration of the study.
|
|
2: No Intervention
Child participants without autism will receive no treatment and will undergo assessments to determine brain functioning only.
|
Children with autism often suffer from social, educational, and functional problems. By understanding the social, linguistic, psychological, and physiological differences that distinguish between autistic children, developmentally delayed children, and children with typical development, researchers may be able to recognize autism early in life so that children with autism can be helped as early as possible and their long-term outcome can be improved.
Children in this study will be enrolled for 2 years. They will receive annual evaluations throughout the two-year period. They will undergo a magnetic resonance imaging (MRI) scan and will complete various activities to determine brain functioning. In addition, children with autism will take part in intensive behavioral therapy at least 4 hours every day for the duration of the study. Communication and social behavior scales, an early development interview, observations of parent/child interaction, and neuropsychological, cognitive, and adaptive behavioral measures will be used to assess participants.
Eligibility| Ages Eligible for Study: | 18 Months to 30 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for Autistic Participants:
Inclusion Criteria for Developmentally Delayed Participants:
Inclusion Criteria for Participants with Normal Development:
Inclusion Criteria for All Participants:
Contacts and Locations More Information
| Responsible Party: | University of Washington ( Geraldine Dawson, PhD ) |
| Study ID Numbers: | U54 MH66399, DDTR BD-DD |
| Study First Received: | August 26, 2004 |
| Last Updated: | September 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00090415 History of Changes |
| Health Authority: | United States: Federal Government |
|
Autism Developmental Delay Disorders |
|
Child Development Disorders, Pervasive Developmental Disabilities Mental Disorders |
Autistic Disorder Mental Disorders Diagnosed in Childhood Autism |
|
Child Development Disorders, Pervasive Mental Disorders Autistic Disorder Mental Disorders Diagnosed in Childhood |
