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

September 7, 2006
February 15, 2007
July 2000
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Complete list of historical versions of study NCT00374764 on ClinicalTrials.gov Archive Site
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Comparison of Applied Behavioral Analysis (ABA) Versus ABA and Risperidone
Randomized Double Blind Comparison of Applied Behavioral Analysis Versus ABA and Risperidone

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.
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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Autistic Disorder
  • Drug: Risperidone
  • Behavioral: ABA
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2002
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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
Both
30 Months to 5 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00374764
IND #58033
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Washington University School of Medicine
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Principal Investigator: Joan Luby, MD Washington University Medical School
Washington University School of Medicine
June 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP