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Sponsors and Collaborators: |
National Institute of Mental Health (NIMH) University of California, Los Angeles |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00004449 |
OBJECTIVES: I. Determine the effectiveness of intensive one-on-one behavioral treatment in the home or neighborhood compared with at home, individualized, parent training in preschool aged children with autism.
II. Identify intake measures that predict differences in outcome between subjects in the experimental group.
Condition | Intervention |
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Autistic Disorder |
Behavioral: intensive one-on-one behavioral treatment Behavioral: Individualized in home parent training |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Estimated Enrollment: | 32 |
Study Start Date: | May 1998 |
Estimated Study Completion Date: | November 1999 |
PROTOCOL OUTLINE: This is a randomized study. Children are randomized to receive either 35 hours of intensive one-on-one behavioral treatment in the home and neighborhood for 2 years or individualized, in home parent training for 6 months.
A common group of tests to evaluate autism are administered at intake, 12 and 24 months into treatment, and when patients reach age 6.
Ages Eligible for Study: | 2 Years to 3 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Diagnosis of autism based on the Autism Diagnostic Interview using the ICD-10 research criteria
Ratio IQ score greater than 35 determined from the Bayley Scales of Infant Development
--Patient Characteristics--
Other:
Must reside within 60 km (37.5 miles) of a treatment site
No severe medically induced limitations defined as:
Study ID Numbers: | 199/13515, UCLA-HSPC-G930506611, R01 MH48863 |
Study First Received: | October 18, 1999 |
Last Updated: | November 29, 2005 |
ClinicalTrials.gov Identifier: | NCT00004449 History of Changes |
Health Authority: | United States: Federal Government |
autism neurologic and psychiatric disorders rare disease |
Developmental Disabilities Child Development Disorders, Pervasive Autistic Disorder Mental Disorders |
Mental Disorders Diagnosed in Childhood Rare Diseases Autism |
Child Development Disorders, Pervasive Mental Disorders Autistic Disorder Mental Disorders Diagnosed in Childhood |