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OpenTrials
Completed

NCT Number: NCT00374764

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

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.

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Key information

Conditions

Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

30 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Early Emotional Development Program

St Louis, Missouri, 63108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risperidone

Drug

ABA

Behavioral

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2000
Study completion
2002
First posted
Sep 11, 2006
Registry last updated
Feb 16, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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