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.
|ClinicalTrials.gov Identifier: NCT00211770|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 12, 2013
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, which involve structured observations and parent/caregiver interviews. Descriptive analyses will be conducted with all participants (n=24). The more rigorous, functional analyses will be conducted with a sub-set of the sample (n=6) to corroborate the findings of the descriptive analyses. Data from the FBAs will be collected using videotaped recordings of behavior and coded by trained raters for both the descriptive and experimental analyses.
Our pilot data and other published data suggest that certain medications such as citalopram (celexa) and divalproex sodium (Depakote) may improve global functioning in autistic patients and repetitive/compulsive behaviors and social deficits. The addition of FBA methods to evaluate outcome are an important step in extending the research and knowledge of the conditions associated with good and poor treatment response to pediatric medications in children with autism.
|Condition or disease||Intervention/treatment|
|Autism||Behavioral: Behavioral Assessment|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||144 participants|
|Official Title:||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.|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2012|
- Behavioral: Behavioral Assessment
functional behavioral assessments are conducted at two separate visits for each subject.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211770
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Latha Soorya||Icahn School of Medicine at Mount Sinai|