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

Autistic Disorder Clinical Trial

Official title:

Randomized Double Blind Comparison of Applied Behavioral Analysis Versus ABA and Risperidone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374764
• Other study ID #: IND #58033
• Status: Completed
• Phase: N/A
• First received: September 7, 2006
• Last updated: February 15, 2007
• Start date: July 2000
• Est. completion date: June 2002

Study information

• Verified date: June 2002
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Months to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder

Intervention

Drug:
• Risperidone

Behavioral:
• ABA

Locations

Country	Name	City	State
United States	Early Emotional Development Program	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references