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NCT00211770 · ClinicalTrials.gov registry record
Use of Functional Behavioral Assessments to Evaluate Stereotypy and Repetitive Behaviors in a Double-blind, Placebo Controlled Trials of Various Medications Used to Treat Children With Autism.
A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- 144
- Enrollment target
NCT00211770 is a clinical trial that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 144 participants.
The verdict
NCT00211770 has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- 144 participants
- Enrollment target
Study Summary
Autism, originally described by Kanner (1943), is among the most severe of neuropsychiatric disorders. It is a pervasive developmental disorder affecting social, communicative, and compulsive/repetitive behaviors characterized by stereotypic complex hand and body movements, craving for sameness, and narrow repetitive interests. Individuals with autism spectrum disorders (ASD) are characteristically heterogeneous and show marked variability in their response to interventions. Studies of behavioral and psychopharmacological interventions document approximately 1/3 of ASD participants fail to respond to targeted treatments. Efforts to evaluate the specificity of treatment effects are important to inform conceptualizations about the disorder, identify behavioral phenotypes, and to aide clinical decision making. The goal of this study is to evaluate the use of clinical behavioral pharmacology methods, functional behavioral assessments (FBA), in assessing the treatment effects of pediatric medications in children with ASD. The present study of FBA procedures in pharmacological treatment will be conducted as a separate, but parallel study within IRB approved, federally funded, double-masked, placebo controlled medication trials of citalopram (GCO # 01-1295 PS\*), an SSRI hypothesized to reduce stereotyped and repetitive behaviors in ASD and divalproex sodium (GCO # 01-0294), a medication recently found to reduce repetitive behaviors in ASD (Hollander et al., in press). This study will focus on the use of FBAs in distinguishing responders vs. nonresponders on the basis of behavior function, in evaluating functional patterns for stereotypy, aggression, and impulsivity, and in using descriptive FBAs as outcome measures in clinical trials. FBAs are behavioral assessment methods used to hypothesize about the function of maladaptive behaviors. FBAs are conducted either through experimental manipulations known as functional analyses or through descriptive analyses procedures, w
Interventions
- BEHAVIORAL Behavioral Assessment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2005-02 |
| Est. Completion | 2012-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00211770
The ClinicalTrials.gov registry entry for NCT00211770 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Behavioral Assessment is the first listed.
NCT00211770 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00211770 about?
NCT00211770 is a clinical study titled "Use of Functional Behavioral Assessments to Evaluate Stereotypy and Repetitive Behaviors in a Double-blind, Placebo Controlled Trials of Various Medications Used to Treat Children With Autism.". Autism, originally described by Kanner (1943), is among the most severe of neuropsychiatric disorders. It is a pervasive developmental disorder affecting social, communicative, and compulsive/repetitive behaviors characterized by stereotypic complex hand and body movements, craving for sameness, and...
What is the current status of trial NCT00211770?
This trial is currently completed. The enrollment target is 144 participants. The study started on 2005-02. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00211770?
The interventions under investigation include: Behavioral Assessment (BEHAVIORAL).
Who is sponsoring clinical trial NCT00211770?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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