CompletedInterventionalPhase 2Updated May 17, 2022
Comparison of Applied Behavioral Analysis (ABA) Versus ABA and Risperidone | NCT00374764 | Trialant
CompletedInterventionalNot ApplicableUpdated Feb 16, 2007
Comparison of Applied Behavioral Analysis (ABA) Versus ABA and Risperidone
Randomized Double Blind Comparison of Applied Behavioral Analysis Versus ABA and Risperidone
ClinicalTrials.gov ID
NCT00374764
Lead Sponsor
Washington University School of MedicineOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
60
Last Update Posted
Feb 16, 2007Estimated
Start Date
Jul 2000
Completion Date
Jun 2002
Official Title
Randomized Double Blind Comparison of Applied Behavioral Analysis Versus ABA and Risperidone
Brief Summary
Hypotheses:
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.
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.
Young age, cognitive development and attentional abilities at baseline will be predictive of good socio-emotional and neuropsychological outcomes after ABA treatment.
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.
Autistic Disorder
Risperidone
ABA
Ages Eligible for Study
Child (0-17)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility 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