Clinical trial NCT00374764: Comparison of Applied Behavioral Analysis (ABA) Versus ABA and Risperidone
Official title: Randomized Double Blind Comparison of Applied Behavioral Analysis Versus ABA and Risperidone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Disorder
Keywords: Autism, Applied Behavioral Analysis, Risperidone
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2006-09-11
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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
* Chronic serious medical problems

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Early Emotional Development Program
state: Missouri
Study officials:
affiliation: Washington University Medical School
name: Joan Luby, MD
role: PRINCIPAL_INVESTIGATOR
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