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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00211770
First received: September 13, 2005
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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 Intervention
Autism
Behavioral: Behavioral Assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Enrollment: 144
Study Start Date: February 2005
Study Completion Date: December 2012
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Behavioral Assessment
    functional behavioral assessments are conducted at two separate visits for each subject.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects who are enrolled in the approved double-blind placebo controlled trial of citalopram in young children with autism.

Criteria

Inclusion Criteria:

  • Male or female of any race or ethnicity.
  • Ambulatory status (outpatient or day-treatment) at time of randomization.
  • Age 5-17 years inclusive at the time of consent
  • Subjects will meet criteria for the diagnosis of Autistic Disorder, Asperger's Disorder, or PDD-NOS as determined by ADI-R administered by raters who are trained to research reliability, and confirmed by an experienced and reliable clinician using DSM-IV-TR criteria.
  • Subjects must also have a score greater than 7 on the first 3 items of the Compulsions Subscale of the Revised CYBOCS.
  • Subjects must have a rating of at least moderate (ratings of 4 or greater) behavioral disturbance based on the modified Clinical Global Impression-Severity of Illness score (CGI-S) at the time of screening (See description below).
  • Subject must demonstrate a mental age >18 months as determined by the Vineland Adaptive Behavior Scales.
  • Subjects must be free of psychotropic medication for at least one month for fluoxetine, two weeks for other SSRIs and neuroleptics, and for 5 days for stimulants prior to baseline ratings.
  • Subjects and their parents (guardians) must be judged reliable for medication compliance and must agree to keep appointments for study visits and tests as outlined in the protocol.
  • Subjects enrolled in an applied behavior analytic educational program for children with autism will be included in the Experimental FBA study only. **

Exclusion Criteria:

  • Subjects who have medical contraindications to therapy with SSRIs as determined by medical history or known allergy.
  • Concomitant medication that would interfere with participation in the study.
  • Subjects with a prior history of treatment failure to a clinically adequate trial of two selective serotonin reuptake inhibitors (SSRI).
  • Subjects with a previous diagnosis of Rett's Disorder or Childhood Disintegrative Disorder.
  • Subjects with documented need for other ongoing psychotropic medications besides study medication (with the exception of stable dose (at least 3 month) anti-convulsants for seizures).
  • Subjects with uncontrolled epilepsy (seizure within past 6 months).
  • Presence of chronic medical conditions that might interfere with study participation or where study participation would be contraindicated, or clinically significant abnormal baseline laboratory testing.
  • Subject with known personal history of bipolar disorder or prior manic episode induced by antidepressant exposure.
  • Subjects with a prior history of an exposure to citalopram of sufficient dose or duration to determine response status.
  • Subjects that are not enrollment in an applied behavior analytic educational program for children with autism will be excluded from the Experimental FBA study only.

    • Cases which do not meet exact inclusion or exclusion criteria but questioned as appropriate by the site PI will be reviewed by the multi-site STAART protocol committee for final decision about study eligibility. The protocol committee will take care to insure that the exception 1) is consistent with the subject's welfare and 2) does not compromise the scientific purpose of the study. Such exceptions will be coded as an approved protocol deviation and will be communicated to the local Institutional Review Board in a timely manner.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211770

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Latha Soorya Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00211770     History of Changes
Other Study ID Numbers: GCO # 04-0629
Study First Received: September 13, 2005
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Autism
Functional Behavioral Assessment
Citalopram

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014