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Comparison of Applied Behavioral Analysis (ABA) Versus ABA and Risperidone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00374764
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : February 16, 2007
Information provided by:
Washington University School of Medicine

Brief Summary:


  1. Preschool children with autism spectrum disorders (ASDs) who undergo ABA treatment only will demonstrate significantly better outcomes compared to an age and severity matched control group without ABA treatment.
  2. Preschool children with ASDs who undergo ABA in combination with risperidone will demonstrate significantly better outcomes compared to age and severity matched children who are receiving ABA alone.
  3. Young age, cognitive development and attentional abilities at baseline will be predictive of good socio-emotional and neuropsychological outcomes after ABA treatment.
  4. At baseline, children with ASDs will show significantly lower performances on measures of cognitive, neuropsychological, and socio-emotional functioning than age-matched typically developing controls.

Condition or disease Intervention/treatment Phase
Autistic Disorder Drug: Risperidone Behavioral: ABA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized Double Blind Comparison of Applied Behavioral Analysis Versus ABA and Risperidone
Study Start Date : July 2000
Study Completion Date : June 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Diagnosis of autism or severe pervasive developmental disorder (PDD) not otherwise specified (NOS) according to the Autism Diagnosis Interview-Revised (ADI-R)
  • Aged 2.6 to 5.0.

Exclusion Criteria:

  • Fragile X or metabolic etiology of PDD symptoms
  • Diagnosis of other central nervous system (CNS) disorders
  • Chronic serious medical problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00374764

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United States, Missouri
Early Emotional Development Program
St. Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
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Principal Investigator: Joan Luby, MD Washington University Medical School
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Bauman, M. & Kemper, T.L. (1988). Limbic and cerebellar abnormalities: Consistent findings in infantile autism. Journal of Neuropathology and Experimental Neurology, 47, 369.
Butterworth, G. & Jarrett, N. (1991). What minds have in common is space: Spatial mechanisms serving joint visual attention in infancy. British Journal of Developmental Psychology, 9. 55-72.
Dawson, G. & Castelloe, P. (1995). Autism. In C.E. Walker & M.C. Roberts (Eds.). Handbook of Clinical Child Psychology. New York. Plenum Press.
Dawson, G. & Lewy, A. (1989). Reciprocal subcortical-cortical influences in autism: The role of attentional mechanisms. In G. Dawons (Ed.), Autism: Nature, Diagnosis, and Treatment (pp. 144-173). New York: Guilford Press.
Dawson, G., Warrenburg, S. & Fuller, P. (1996. Early intervention in autism. In M.J. Guralnick (Ed.), The Effectiveness of Early Intervention. Baltimore, MD: Paul Brookes Publishing Co.
Diamond, A. & Goldman-Rakic, P.S. (1985). Evidence for involvement of prefrontal cortex in cognitive changes during the first year of life: comparison of human infants to rhesus monkeys on a detour task with transparent barrier. Society for Neurosciences Abstracts (Part II), 11, 832.
Diamond, A. & Goldman-Rakic, P.S. (1986). Comparative development in human infants and infant rhesus monkeys on cognitive functions that depend on the prefrontal cortex. Society of Neurosciences Abstracts, 12, 742.
Fenske, E.D., Zalenski, S., Krantz, P.J., & McClannahan, L.E. (1985). Age at intervention and treatment outcome for autistic children in a comprehensive intervention program. Analysis and Intervention in Developmental Disabilities, 5, 49-58.
Gilliam, J.E. (1995). Gilliam Autism Rating Scale, Austin, TX: PRO-ED, Inc.
Goldman-Rakic, P.S. (1987). Circuitry of primate prefrontal cortex and regulation of behavior by representational knowledge. In F. Plum & V. Mountcastle (Eds.), Handbook of Physiology, 5, 373-417.
Goldsmith, H.H. & Rothbart, M.K. (1996). The Laboratory Temperament Assessment Battery, Locomotor Version 3.0. Madison, Wisconsin: Department of psychology, University of Wisconsin.
Elyse, P., Luby, J., Abbacchi, A., & Constantino, J.N. Quantitative Assessment of Autistic Symptomatology in Preshoolers. In Press.

Layout table for additonal information Identifier: NCT00374764    
Other Study ID Numbers: IND #58033
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: February 16, 2007
Last Verified: June 2002
Keywords provided by Washington University School of Medicine:
Autism, Applied Behavioral Analysis, Risperidone
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents