Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211770
Status:
COMPLETED
Last Update Posted:
2013-06-12
First Post:
2005-09-13
Brief 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
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 compulsiverepetitive 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 13 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 parentcaregiver interviews Descriptive analyses will be conducted with all participants n24 The more rigorous functional analyses will be conducted with a sub-set of the sample n6 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 repetitivecompulsive 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
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 parentcaregiver interviews Descriptive analyses will be conducted with all participants n24 The more rigorous functional analyses will be conducted with a sub-set of the sample n6 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 repetitivecompulsive 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
Detailed Description:
Research geared towards increasing knowledge of the variables contributing to treatment response is critical to advancing intervention studies in ASD Literature in the growing field of clinical behavioral pharmacology suggests functional behavioral assessments FBA when integrated into clinical trials of medication can be important tools in elucidating the specificity of treatment effects Mace Mauk 1995 Northup Gully 2001 The goal of this study is to evaluate the use of clinical behavioral pharmacology methods primarily descriptive functional behavioral assessments FBA in a double-masked placebo controlled trial of medications used to treat children with autism These medications are hypothesized to reduce the stereotyped and repetitive behaviors in ASD This study will focus on the use of descriptive FBAs in distinguishing responders vs non-responders on the basis of behavior function in evaluating functional patterns for stereotypy and in using descriptive FBAs as outcome measures in clinical trials
This study is accordance with CAN research priorities in its focus on improving methodological approaches in clinical trials Hollander et al 2004 This study is also consistent with recent NIMH recommendations for clinical research The recommendations identify the integration of behavioral research methods with traditional methods of clinical research ie group designs as important aims for ASD treatment research CPEASTAART working group 2004 As such this study fills significant gaps in two research areas treatments for repetitive behaviors and research methodology in treatment trials for individuals with ASD
The bio-behavioral methods proposed for use in this evaluation have been previously used to stratify and match treatments for self-injurious behavior in adults with developmental disabilities Mace Mauk 1995 identify specific treatment effects of methylphenidate in children with ADHD Northup Gully 2001 and more recently in evaluating the specificity of risperidones effects on destructive behaviors in individuals with autism Crosland et al 2003
Despite that stereotyped and repetitive behaviors are a core symptom domain of ASD behavioral pharmacology approaches to date have only evaluated the correlated symptoms of aggression self-injurious and destructive behaviors in ASD Repetitive behaviors in ASD include stereotypic movements repetition of routine behaviors repetitive play perseverative speech and over-focus on restricted interests These repetitive movements may be associated with emotional distress tension or dysphoria and have significant impacts on daily life It is believed that the methods used to elucidate and specify treatment effects in other medications and disorders will also be valuable to the understanding of SSRI effects in autism
Both behavioral and pharmacological treatments have been used to treat repetitive and stereotyped behaviors in autism Behavioral treatments include the use of noncontingent reinforcement Britton et al 2002 and alternative response training to maintain homeostasis Johnson Laarhoven Repp 2002 Psychopharmacological approaches include the use of SSRIs given the similarity between repetitive behaviors in autism and OCD McDougle 1995 and evidence for serotonin dysfunction in ASD Hollander 2000 To date there are few controlled studies with any of the SSRIs in pediatric populations with ASD Hollander colleagues Hollander et al in press at Mt Sinai recently completed a study suggesting the efficacy of low-dose liquid fluoxetine on reducing repetitive behaviors in a double-blind placebo controlled crossover study of 45 children with ASD This proposed FBA evaluation would occur within another SSRI trial at Mt Sinai which aims to extend previous findings in a large scale multisite investigation of the safety and efficacy of liquid citalopram in children with ASD
Behavioral pharmacology methods Functional behavioral assessments FBA are the cornerstone of clinical behavioral pharmacology approaches The goals of FBAs are to hypothesize and experimentally test the functions of maladaptive behaviors Within the field of behavior analysis determining the function of the maladaptive behavior is primary to developing effective interventions
FBAs involve both experimental and descriptive assessments of behavior functions Experimental methods also known as functional analyses Iwata et al 19821994 have the advantage of using experimental manipulations and direct continuous observations of behavior The procedures outlined by Iwata et al 19821994 are considered the gold-standard for functional analyses The procedure involves the use of multi-element single-subject experimental design During the functional analysis consequences presented for a maladaptive behavior are varied The experimental conditions outlined by Iwata et al 19821994 are labeled by the presumed function tested in a condition and include escapeavoidance attention automatic reinforcementself-stimulation and control ie preferred toys social attention
Experimental methods provide valuable and reliable data on behavior functions but involve significant time and expense for patients and experimenters In contrast descriptive methods are based on parentcaregiver-report direct behavioral observations and provide information on both consequent and antecedent predictors of behavior Descriptive methods are strongly correlated with experimental analyses and have advantages because of the information provided on antecedent functions and in their relative cost-effectiveness Horner et al 1997 This study will pilot the use of descriptive assessment methods as an outcome measure and use experimental FBAs to corroborate the results of the descriptive analyses
The methods and outcome of this investigation will be used to design an independent clinical trial using a multi-method approach including descriptive and experimental FBAs as outcome measures in medication studies of repetitive behaviors in ASD Given this research has limited funding options outside of CAN funding this project may be a critical preliminary step in improving our treatment-specificity research and clinical research methods in ASD
Specific Aims
The primary aim of this study is to determine the usability of functional behavioral assessment FBA procedures in predicting and measuring treatment response within a clinical trial of citalopram an SSRI hypothesized to reduce repetitive behaviors in ASD The specific aims of the study are as follows
1 To predict treatment response through results from descriptive FBAs
2 To evaluate functional patterns for stereotypyrepetitive behaviors in ASD
3 To evaluate the use of descriptive FBAs as outcome measures in SSRI trials in ASD and to correlate results from descriptive FBAs with standard global rating measures such as the Child Yale-Brown Obsessive Compulsive Scale CYBOCS and the Aberrant Behavior Checklist ABC for repetitive behaviors and stereotypy
This study is accordance with CAN research priorities in its focus on improving methodological approaches in clinical trials Hollander et al 2004 This study is also consistent with recent NIMH recommendations for clinical research The recommendations identify the integration of behavioral research methods with traditional methods of clinical research ie group designs as important aims for ASD treatment research CPEASTAART working group 2004 As such this study fills significant gaps in two research areas treatments for repetitive behaviors and research methodology in treatment trials for individuals with ASD
The bio-behavioral methods proposed for use in this evaluation have been previously used to stratify and match treatments for self-injurious behavior in adults with developmental disabilities Mace Mauk 1995 identify specific treatment effects of methylphenidate in children with ADHD Northup Gully 2001 and more recently in evaluating the specificity of risperidones effects on destructive behaviors in individuals with autism Crosland et al 2003
Despite that stereotyped and repetitive behaviors are a core symptom domain of ASD behavioral pharmacology approaches to date have only evaluated the correlated symptoms of aggression self-injurious and destructive behaviors in ASD Repetitive behaviors in ASD include stereotypic movements repetition of routine behaviors repetitive play perseverative speech and over-focus on restricted interests These repetitive movements may be associated with emotional distress tension or dysphoria and have significant impacts on daily life It is believed that the methods used to elucidate and specify treatment effects in other medications and disorders will also be valuable to the understanding of SSRI effects in autism
Both behavioral and pharmacological treatments have been used to treat repetitive and stereotyped behaviors in autism Behavioral treatments include the use of noncontingent reinforcement Britton et al 2002 and alternative response training to maintain homeostasis Johnson Laarhoven Repp 2002 Psychopharmacological approaches include the use of SSRIs given the similarity between repetitive behaviors in autism and OCD McDougle 1995 and evidence for serotonin dysfunction in ASD Hollander 2000 To date there are few controlled studies with any of the SSRIs in pediatric populations with ASD Hollander colleagues Hollander et al in press at Mt Sinai recently completed a study suggesting the efficacy of low-dose liquid fluoxetine on reducing repetitive behaviors in a double-blind placebo controlled crossover study of 45 children with ASD This proposed FBA evaluation would occur within another SSRI trial at Mt Sinai which aims to extend previous findings in a large scale multisite investigation of the safety and efficacy of liquid citalopram in children with ASD
Behavioral pharmacology methods Functional behavioral assessments FBA are the cornerstone of clinical behavioral pharmacology approaches The goals of FBAs are to hypothesize and experimentally test the functions of maladaptive behaviors Within the field of behavior analysis determining the function of the maladaptive behavior is primary to developing effective interventions
FBAs involve both experimental and descriptive assessments of behavior functions Experimental methods also known as functional analyses Iwata et al 19821994 have the advantage of using experimental manipulations and direct continuous observations of behavior The procedures outlined by Iwata et al 19821994 are considered the gold-standard for functional analyses The procedure involves the use of multi-element single-subject experimental design During the functional analysis consequences presented for a maladaptive behavior are varied The experimental conditions outlined by Iwata et al 19821994 are labeled by the presumed function tested in a condition and include escapeavoidance attention automatic reinforcementself-stimulation and control ie preferred toys social attention
Experimental methods provide valuable and reliable data on behavior functions but involve significant time and expense for patients and experimenters In contrast descriptive methods are based on parentcaregiver-report direct behavioral observations and provide information on both consequent and antecedent predictors of behavior Descriptive methods are strongly correlated with experimental analyses and have advantages because of the information provided on antecedent functions and in their relative cost-effectiveness Horner et al 1997 This study will pilot the use of descriptive assessment methods as an outcome measure and use experimental FBAs to corroborate the results of the descriptive analyses
The methods and outcome of this investigation will be used to design an independent clinical trial using a multi-method approach including descriptive and experimental FBAs as outcome measures in medication studies of repetitive behaviors in ASD Given this research has limited funding options outside of CAN funding this project may be a critical preliminary step in improving our treatment-specificity research and clinical research methods in ASD
Specific Aims
The primary aim of this study is to determine the usability of functional behavioral assessment FBA procedures in predicting and measuring treatment response within a clinical trial of citalopram an SSRI hypothesized to reduce repetitive behaviors in ASD The specific aims of the study are as follows
1 To predict treatment response through results from descriptive FBAs
2 To evaluate functional patterns for stereotypyrepetitive behaviors in ASD
3 To evaluate the use of descriptive FBAs as outcome measures in SSRI trials in ASD and to correlate results from descriptive FBAs with standard global rating measures such as the Child Yale-Brown Obsessive Compulsive Scale CYBOCS and the Aberrant Behavior Checklist ABC for repetitive behaviors and stereotypy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None