- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004449
Randomized Study of Intensive One-on-one Behavioral Treatment for Preschool Aged Children With Autism
Randomized Study of Intensive One-on-one Behavioral Treatment Versus Individualized Parent Training in Preschool Aged Children With Autism
OBJECTIVES: I. Determine the effectiveness of intensive one-on-one behavioral treatment in the home or neighborhood compared with at home, individualized, parent training in preschool aged children with autism.
II. Identify intake measures that predict differences in outcome between subjects in the experimental group.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PROTOCOL OUTLINE: This is a randomized study. Children are randomized to receive either 35 hours of intensive one-on-one behavioral treatment in the home and neighborhood for 2 years or individualized, in home parent training for 6 months.
A common group of tests to evaluate autism are administered at intake, 12 and 24 months into treatment, and when patients reach age 6.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
--Disease Characteristics--
Diagnosis of autism based on the Autism Diagnostic Interview using the ICD-10 research criteria
Ratio IQ score greater than 35 determined from the Bayley Scales of Infant Development
--Patient Characteristics--
Other:
Must reside within 60 km (37.5 miles) of a treatment site
EXCLUSION CRITERIA:
Severe medically induced limitations defined as:
- Any condition requiring prosthetic devices (e.g., blindness, deafness, or cerebral palsy)
- Any illness that has prevented or would prevent a subject from participating in 30 hours a week of treatment for six consecutive weeks or more (e.g., metastasized cancer or end stage renal disease)
- Any known genetic disorder (e.g., Fragile X, PKU, or Down Syndrome)
- Any other disorder that rules out autism according to ICD-10 criteria (e.g., Rett's Syndrome)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wechsler Preschool and Primary Scales of Intelligence, 3rd ed.
Time Frame: yearly for up to 4 years
|
IQ
|
yearly for up to 4 years
|
Bayley Scales of Infant Development
Time Frame: yearly for up to 4 years
|
Alternate cognitive test administered to participants who did not achieve basal on WPPSI-III
|
yearly for up to 4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Merrill-Palmer Scale of Mental Tests
Time Frame: yearly for up to 4 years
|
Nonverbal cognitive skills
|
yearly for up to 4 years
|
Reynell Developmental Language Scales
Time Frame: yearly for up to 4 years
|
Language comprehension and expressive language
|
yearly for up to 4 years
|
Vineland Adaptive Behavior Scales - Survey Edition
Time Frame: yearly for up to 4 years
|
Parent interview on child's adaptive functioning
|
yearly for up to 4 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Tristram Smith, Ph.D., University of Rochester
Publications and helpful links
General Publications
- Cohen H, Amerine-Dickens M, Smith T. Early intensive behavioral treatment: replication of the UCLA model in a community setting. J Dev Behav Pediatr. 2006 Apr;27(2 Suppl):S145-55. doi: 10.1097/00004703-200604002-00013.
- Sallows GO, Graupner TD. Intensive behavioral treatment for children with autism: four-year outcome and predictors. Am J Ment Retard. 2005 Nov;110(6):417-38. doi: 10.1352/0895-8017(2005)110[417:IBTFCW]2.0.CO;2.
- Hayward D, Eikeseth S, Gale C, Morgan S. Assessing progress during treatment for young children with autism receiving intensive behavioural interventions. Autism. 2009 Nov;13(6):613-33. doi: 10.1177/1362361309340029.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH048863 (U.S. NIH Grant/Contract)
- UCLA-HSPC-G930506611
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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