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

This study has been completed.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00374764
First received: September 7, 2006
Last updated: February 15, 2007
Last verified: June 2002
  Purpose

Hypotheses:

  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 Intervention
Autistic Disorder
Drug: Risperidone
Behavioral: ABA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Double Blind Comparison of Applied Behavioral Analysis Versus ABA and Risperidone

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Estimated Enrollment: 60
Study Start Date: July 2000
Estimated Study Completion Date: June 2002
  Eligibility

Ages Eligible for Study:   30 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374764

Locations
United States, Missouri
Early Emotional Development Program
St. Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Joan Luby, MD Washington University Medical School
  More Information

Publications:
Bachevalier, J. (1991). Memory loss and socio-emotional disturbances following neonatal damage of the limbic system in monkeys: An animal model for childhood autism. In C. Tamminga & S. Schulz (Eds.). Advances in Psychiatry and Psychopharmacology (pp. 129-140). New York: Raven Press.
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.
Charman, T., Swettenham, J., Baron-Cohen, S., Cox, A., Baird, G. & Drew, A.(1997). Developmental Psychology, 33(5), 781-789.
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.
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.

ClinicalTrials.gov Identifier: NCT00374764     History of Changes
Other Study ID Numbers: IND #58033
Study First Received: September 7, 2006
Last Updated: February 15, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
Autism, Applied Behavioral Analysis, Risperidone

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 28, 2014