NCT00374764

Brief Summary

Hypotheses:

  1. 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. 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. 3.Young age, cognitive development and attentional abilities at baseline will be predictive of good socio-emotional and neuropsychological outcomes after ABA treatment.
  4. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2000

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
Last Updated

February 16, 2007

Status Verified

June 1, 2002

First QC Date

September 7, 2006

Last Update Submit

February 15, 2007

Conditions

Autistic Disorder

Keywords

Autism, Applied Behavioral Analysis, Risperidone

Interventions

RisperidoneDRUG
ABABEHAVIORAL

Eligibility Criteria

Age30 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Fragile X or metabolic etiology of PDD symptoms
  • Diagnosis of other central nervous system (CNS) disorders
  • Chronic serious medical problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Early Emotional Development Program

St Louis, Missouri, 63108, United States

Location

Related Publications (25)

  • 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.

    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.

    PMID: 8837904BACKGROUND

  • Bauman, M. & Kemper, T.L. (1988). Limbic and cerebellar abnormalities: Consistent findings in infantile autism. Journal of Neuropathology and Experimental Neurology, 47, 369.

    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.

    PMID: 9578989BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 9300211BACKGROUND

  • 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.

    PMID: 9578992BACKGROUND

  • 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.

    PMID: 3945811BACKGROUND

  • 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.

    PMID: 8424359BACKGROUND

  • Damasio AR, Maurer RG. A neurological model for childhood autism. Arch Neurol. 1978 Dec;35(12):777-86. doi: 10.1001/archneur.1978.00500360001001.

    PMID: 718482BACKGROUND

  • 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.

    PMID: 6725782BACKGROUND

  • Dawson, G. & Castelloe, P. (1995). Autism. In C.E. Walker & M.C. Roberts (Eds.). Handbook of Clinical Child Psychology. New York. Plenum Press.

    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.

    PMID: 8568080BACKGROUND

  • 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.

    BACKGROUND

  • Dawson G, Meltzoff AN, Osterling J, Rinaldi J. Neuropsychological correlates of early symptoms of autism. Child Dev. 1998 Oct;69(5):1276-85.

    PMID: 9839415BACKGROUND

  • 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.

    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.

    PMID: 7074350BACKGROUND

  • 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.

    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.

    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.

    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.

    PMID: 1624921BACKGROUND

  • Gilliam, J.E. (1995). Gilliam Autism Rating Scale, Austin, TX: PRO-ED, Inc.

    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.

    BACKGROUND

  • Goldsmith, H.H. & Rothbart, M.K. (1996). The Laboratory Temperament Assessment Battery, Locomotor Version 3.0. Madison, Wisconsin: Department of psychology, University of Wisconsin.

    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.

    PMID: 16908478BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Joan Luby, MD

    Washington University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 11, 2006

Study Start

July 1, 2000

Study Completion

June 1, 2002

Last Updated

February 16, 2007

Record last verified: 2002-06

Locations

US(1)