Autistic DisorderNCT00374764
Comparison of Applied Behavioral Analysis (ABA) Versus ABA and Risperidone
A study testing Risperidone and ABA in people with Autistic Disorder, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Risperidone and ABA
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2000to Jun 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Fragile X or metabolic etiology of PDD symptoms
- Diagnosis of other central nervous system (CNS) disorders
- Chronic serious medical problems
Trial locations and contacts
1 site in 1 country.
United States1 site
Early Emotional Development Program
St Louis, Missouri, 63108
About this study
Official title: Randomized Double Blind Comparison of Applied Behavioral Analysis Versus ABA and Risperidone
Hypotheses:
- 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.
- 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.
- Young age, cognitive development and attentional abilities at baseline will be predictive of good socio-emotional and neuropsychological outcomes after ABA treatment.
- 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.
- Conditions
- Autistic Disorder
- Being tested
- Risperidone, ABA
- Keywords
- Autism, Applied Behavioral Analysis, Risperidone
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
ABABehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startJul 2000
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Joan Luby, MD, Principal investigator, Washington University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374764
- Sponsor's protocol ID
- IND #58033
- Status last verified
- Jun 2002
- First submitted
- 7 Sep 2006
- Last updated
- 16 Feb 2007
- Results posted
- No
Publications
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.
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.
PubMed 8837904Bauman, M. & Kemper, T.L. (1988). Limbic and cerebellar abnormalities: Consistent findings in infantile autism. Journal of Neuropathology and Experimental Neurology, 47, 369.
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.
PubMed 9578989Butterworth, 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.
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.
PubMed 9300211Chugani 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.
PubMed 9578992Chugani 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.
PubMed 3945811Courchesne 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.
PubMed 8424359Damasio AR, Maurer RG. A neurological model for childhood autism. Arch Neurol. 1978 Dec;35(12):777-86. doi: 10.1001/archneur.1978.00500360001001.
PubMed 718482Dawson G, Adams A. Imitation and social responsiveness in autistic children. J Abnorm Child Psychol. 1984 Jun;12(2):209-25. doi: 10.1007/BF00910664.
PubMed 6725782Dawson, G. & Castelloe, P. (1995). Autism. In C.E. Walker & M.C. Roberts (Eds.). Handbook of Clinical Child Psychology. New York. Plenum Press.
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.
PubMed 8568080Dawson, 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.
Dawson G, Meltzoff AN, Osterling J, Rinaldi J. Neuropsychological correlates of early symptoms of autism. Child Dev. 1998 Oct;69(5):1276-85.
PubMed 9839415
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Comparison of Applied Behavioral Analysis Versus ABA and Risperidone
- ClinicalTrials.gov ID
- NCT00374764
- Acronym / sponsor ID
- IND #58033
- Conditions
- Autistic Disorder
- Keywords
- Autism, Applied Behavioral Analysis, Risperidone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jul 2000
- Study completion
- Jun 2002
- First posted
- 11 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypotheses:
- 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.
- 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.
- Young age, cognitive development and attentional abilities at baseline will be predictive of good socio-emotional and neuropsychological outcomes after ABA treatment.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Fragile X or metabolic etiology of PDD symptoms
- Diagnosis of other central nervous system (CNS) disorders
- Chronic serious medical problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risperidone | Drug | – |
| ABA | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2007.
- BackgroundBachevalier, 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: PubMed 8837904Baron-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.
- BackgroundBauman, M. & Kemper, T.L. (1988). Limbic and cerebellar abnormalities: Consistent findings in infantile autism. Journal of Neuropathology and Experimental Neurology, 47, 369.
- Background: PubMed 9578989Black 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.
- BackgroundButterworth, 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: PubMed 9300211Charman 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.
- Background: PubMed 9578992Chugani 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.
- Background: PubMed 3945811Chugani 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.
- Background: PubMed 8424359Courchesne 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.
- Background: PubMed 718482Damasio AR, Maurer RG. A neurological model for childhood autism. Arch Neurol. 1978 Dec;35(12):777-86. doi: 10.1001/archneur.1978.00500360001001.
- Background: PubMed 6725782Dawson G, Adams A. Imitation and social responsiveness in autistic children. J Abnorm Child Psychol. 1984 Jun;12(2):209-25. doi: 10.1007/BF00910664.
- BackgroundDawson, G. & Castelloe, P. (1995). Autism. In C.E. Walker & M.C. Roberts (Eds.). Handbook of Clinical Child Psychology. New York. Plenum Press.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Luby, MD principal investigator
Washington University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risperidone and ABA in people with Autistic Disorder, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00374764, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2007.