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

ID: NCT00374764
Status: Completed
Phase: N/A
Start Date: July 01, 2000
First Submitted: September 07, 2006
Last Updated: February 15, 2007
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Autistic Disorder
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Autistic Disorder

Drug: Risperidone
Other Names
Behavioral: ABA
Other Names
N/A

Tracking Information

First Submitted DateSeptember 07, 2006
Last Update Posted DateFebruary 15, 2007
Start DateJuly 01, 2000
Completion DateJune 01, 2002
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

Not Available

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleComparison of Applied Behavioral Analysis (ABA) Versus ABA and Risperidone
Official TitleRandomized Double Blind Comparison of Applied Behavioral Analysis Versus ABA and Risperidone
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.

Detailed Description

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
60
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Treatment
Conditions
Autistic Disorder
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Risperidone

Other Names
Behavioral: ABA

Other Names
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Completed
Enrollment60
Completion DateJune 01, 2002
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
GenderAll
Age30 Months to 5 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00374764
Other Study ID Numbers
IND #58033
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyN/A
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Principal Investigator
Joan Luby, MD
Washington University Medical School

Publications