Comparison of Applied Behavioral Analysis (ABA) Versus ABA and Risperidone
NCT ID: NCT00374764
Last Updated: 2007-02-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2000-07-31
Study Completion Date
2002-06-30
Brief Summary
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Hypotheses:
1. Preschool children with autism spectrum disorders (ASDs) who undergo ABA treatment only will demonstrate significantly better outcomes compared to an age and severity matched control group without ABA treatment.
2. Preschool children with ASDs who undergo ABA in combination with risperidone will demonstrate significantly better outcomes compared to age and severity matched children who are receiving ABA alone.
3. Young age, cognitive development and attentional abilities at baseline will be predictive of good socio-emotional and neuropsychological outcomes after ABA treatment.
4. At baseline, children with ASDs will show significantly lower performances on measures of cognitive, neuropsychological, and socio-emotional functioning than age-matched typically developing controls.
1. Preschool children with autism spectrum disorders (ASDs) who undergo ABA treatment only will demonstrate significantly better outcomes compared to an age and severity matched control group without ABA treatment.
2. Preschool children with ASDs who undergo ABA in combination with risperidone will demonstrate significantly better outcomes compared to age and severity matched children who are receiving ABA alone.
3. Young age, cognitive development and attentional abilities at baseline will be predictive of good socio-emotional and neuropsychological outcomes after ABA treatment.
4. At baseline, children with ASDs will show significantly lower performances on measures of cognitive, neuropsychological, and socio-emotional functioning than age-matched typically developing controls.
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Detailed Description
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Conditions
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Autistic Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Interventions
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Risperidone
Intervention Type
DRUG
ABA
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of autism or severe pervasive developmental disorder (PDD) not otherwise specified (NOS) according to the Autism Diagnosis Interview-Revised (ADI-R)
* Aged 2.6 to 5.0.
* Aged 2.6 to 5.0.
Exclusion Criteria
* Fragile X or metabolic etiology of PDD symptoms
* Diagnosis of other central nervous system (CNS) disorders
* Chronic serious medical problems
* Diagnosis of other central nervous system (CNS) disorders
* Chronic serious medical problems
Minimum Eligible Age
30 Months
Maximum Eligible Age
5 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Washington University School of Medicine
OTHER
Sponsor Role
lead
Principal Investigators
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Joan Luby, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University Medical School
Locations
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Early Emotional Development Program
St Louis, Missouri, United States
Site Status
Countries
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United States
References
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Bachevalier, J. (1991). Memory loss and socio-emotional disturbances following neonatal damage of the limbic system in monkeys: An animal model for childhood autism. In C. Tamminga & S. Schulz (Eds.). Advances in Psychiatry and Psychopharmacology (pp. 129-140). New York: Raven Press.
Reference Type
BACKGROUND
Baron-Cohen S, Cox A, Baird G, Swettenham J, Nightingale N, Morgan K, Drew A, Charman T. Psychological markers in the detection of autism in infancy in a large population. Br J Psychiatry. 1996 Feb;168(2):158-63. doi: 10.1192/bjp.168.2.158.
Reference Type
BACKGROUND
Bauman, M. & Kemper, T.L. (1988). Limbic and cerebellar abnormalities: Consistent findings in infantile autism. Journal of Neuropathology and Experimental Neurology, 47, 369.
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BACKGROUND
Black JE. How a child builds its brain: some lessons from animal studies of neural plasticity. Prev Med. 1998 Mar-Apr;27(2):168-71. doi: 10.1006/pmed.1998.0271.
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BACKGROUND
Butterworth, G. & Jarrett, N. (1991). What minds have in common is space: Spatial mechanisms serving joint visual attention in infancy. British Journal of Developmental Psychology, 9. 55-72.
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Charman T, Swettenham J, Baron-Cohen S, Cox A, Baird G, Drew A. Infants with autism: an investigation of empathy, pretend play, joint attention, and imitation. Dev Psychol. 1997 Sep;33(5):781-9. doi: 10.1037//0012-1649.33.5.781.
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Chugani HT. A critical period of brain development: studies of cerebral glucose utilization with PET. Prev Med. 1998 Mar-Apr;27(2):184-8. doi: 10.1006/pmed.1998.0274.
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Chugani HT, Phelps ME. Maturational changes in cerebral function in infants determined by 18FDG positron emission tomography. Science. 1986 Feb 21;231(4740):840-3. doi: 10.1126/science.3945811.
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BACKGROUND
Courchesne E, Press GA, Yeung-Courchesne R. Parietal lobe abnormalities detected with MR in patients with infantile autism. AJR Am J Roentgenol. 1993 Feb;160(2):387-93. doi: 10.2214/ajr.160.2.8424359.
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BACKGROUND
Damasio AR, Maurer RG. A neurological model for childhood autism. Arch Neurol. 1978 Dec;35(12):777-86. doi: 10.1001/archneur.1978.00500360001001.
Reference Type
BACKGROUND
Dawson G, Adams A. Imitation and social responsiveness in autistic children. J Abnorm Child Psychol. 1984 Jun;12(2):209-25. doi: 10.1007/BF00910664.
Reference Type
BACKGROUND
Dawson, G. & Castelloe, P. (1995). Autism. In C.E. Walker & M.C. Roberts (Eds.). Handbook of Clinical Child Psychology. New York. Plenum Press.
Reference Type
BACKGROUND
Dawson G, Klinger LG, Panagiotides H, Lewy A, Castelloe P. Subgroups of autistic children based on social behavior display distinct patterns of brain activity. J Abnorm Child Psychol. 1995 Oct;23(5):569-83. doi: 10.1007/BF01447662.
Reference Type
BACKGROUND
Dawson, G. & Lewy, A. (1989). Reciprocal subcortical-cortical influences in autism: The role of attentional mechanisms. In G. Dawons (Ed.), Autism: Nature, Diagnosis, and Treatment (pp. 144-173). New York: Guilford Press.
Reference Type
BACKGROUND
Dawson G, Meltzoff AN, Osterling J, Rinaldi J. Neuropsychological correlates of early symptoms of autism. Child Dev. 1998 Oct;69(5):1276-85.
Reference Type
BACKGROUND
Dawson, G., Warrenburg, S. & Fuller, P. (1996. Early intervention in autism. In M.J. Guralnick (Ed.), The Effectiveness of Early Intervention. Baltimore, MD: Paul Brookes Publishing Co.
Reference Type
BACKGROUND
Dawson G, Warrenburg S, Fuller P. Cerebral lateralization in individuals diagnosed as autistic in early childhood. Brain Lang. 1982 Mar;15(2):353-68. doi: 10.1016/0093-934x(82)90065-7. No abstract available.
Reference Type
BACKGROUND
Diamond, A. & Goldman-Rakic, P.S. (1985). Evidence for involvement of prefrontal cortex in cognitive changes during the first year of life: comparison of human infants to rhesus monkeys on a detour task with transparent barrier. Society for Neurosciences Abstracts (Part II), 11, 832.
Reference Type
BACKGROUND
Diamond, A. & Goldman-Rakic, P.S. (1986). Comparative development in human infants and infant rhesus monkeys on cognitive functions that depend on the prefrontal cortex. Society of Neurosciences Abstracts, 12, 742.
Reference Type
BACKGROUND
Fenske, E.D., Zalenski, S., Krantz, P.J., & McClannahan, L.E. (1985). Age at intervention and treatment outcome for autistic children in a comprehensive intervention program. Analysis and Intervention in Developmental Disabilities, 5, 49-58.
Reference Type
BACKGROUND
George MS, Costa DC, Kouris K, Ring HA, Ell PJ. Cerebral blood flow abnormalities in adults with infantile autism. J Nerv Ment Dis. 1992 Jul;180(7):413-7. doi: 10.1097/00005053-199207000-00002.
Reference Type
BACKGROUND
Gilliam, J.E. (1995). Gilliam Autism Rating Scale, Austin, TX: PRO-ED, Inc.
Reference Type
BACKGROUND
Goldman-Rakic, P.S. (1987). Circuitry of primate prefrontal cortex and regulation of behavior by representational knowledge. In F. Plum & V. Mountcastle (Eds.), Handbook of Physiology, 5, 373-417.
Reference Type
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Goldsmith, H.H. & Rothbart, M.K. (1996). The Laboratory Temperament Assessment Battery, Locomotor Version 3.0. Madison, Wisconsin: Department of psychology, University of Wisconsin.
Reference Type
BACKGROUND
Pine E, Luby J, Abbacchi A, Constantino JN. Quantitative assessment of autistic symptomatology in preschoolers. Autism. 2006 Jul;10(4):344-52. doi: 10.1177/1362361306064434.
Reference Type
BACKGROUND
Other Identifiers
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IND #58033
Identifier Type: -
Identifier Source: org_study_id
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