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

Primary Purpose

Autistic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Risperidone
ABA
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorder focused on measuring Autism, Applied Behavioral Analysis, Risperidone

Eligibility Criteria

30 Months - 5 Years (Child)All SexesAccepts 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

Sites / Locations

  • Early Emotional Development Program

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 7, 2006
Last Updated
February 15, 2007
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00374764
Brief Title
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

2. Study Status

Record Verification Date
June 2002
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Washington University School of Medicine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
Autism, Applied Behavioral Analysis, Risperidone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Type
Behavioral
Intervention Name(s)
ABA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Luby, MD
Organizational Affiliation
Washington University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Early Emotional Development Program
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States

12. IPD Sharing Statement

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

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