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

The Washington University

Status: Completed

Conditions: Autistic Disorder

Treatments: Drug: Risperidone; Behavioral: ABA

Study type: Interventional

Funder types: Other

Identifiers

NCT00374764

IND #58033

Details and patient eligibility

About

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.

Sex: All

Ages: 30 months to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind