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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.

NCT00211770 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 144

Last updated 2013-06-12

No results posted yet for this 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, 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.

Conditions

Interventions

BEHAVIORAL

Behavioral Assessment

functional behavioral assessments are conducted at two separate visits for each subject.

Sponsors & Collaborators

Principal Investigators

  • Latha Soorya · Icahn School of Medicine at Mount Sinai

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2005-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00211770 on ClinicalTrials.gov