Back to resultsRandomized Study of Intensive One-on-one Behavioral Treatment for Preschool Aged Children With Autism
Primary Purpose
Autistic Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intensive one-on-one behavioral treatment
Individualized in home parent training
Sponsored by
About this trial
This is an interventional treatment trial for Autistic Disorder focused on measuring autism, neurologic and psychiatric disorders, rare disease
Eligibility Criteria
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)
Sites / Locations
Outcomes
Primary Outcome Measures
Wechsler Preschool and Primary Scales of Intelligence, 3rd ed.
IQ
Bayley Scales of Infant Development
Alternate cognitive test administered to participants who did not achieve basal on WPPSI-III
Secondary Outcome Measures
Merrill-Palmer Scale of Mental Tests
Nonverbal cognitive skills
Reynell Developmental Language Scales
Language comprehension and expressive language
Vineland Adaptive Behavior Scales - Survey Edition
Parent interview on child's adaptive functioning
Full Information
NCT ID
NCT00004449
First Posted
October 18, 1999
Last Updated
May 26, 2015
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00004449
Brief Title
Randomized Study of Intensive One-on-one Behavioral Treatment for Preschool Aged Children With Autism
Official Title
Randomized Study of Intensive One-on-one Behavioral Treatment Versus Individualized Parent Training in Preschool Aged Children With Autism
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 1998 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
autism, neurologic and psychiatric disorders, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
intensive one-on-one behavioral treatment
Intervention Description
Up to 40 hours per week of one-to-one intervention based on applied behavior analysis
Intervention Type
Behavioral
Intervention Name(s)
Individualized in home parent training
Intervention Description
Offered to subjects at some sites, involved 3+ months of individualized training for parents on applied behavior analysis intervention
Primary Outcome Measure Information:
Title
Wechsler Preschool and Primary Scales of Intelligence, 3rd ed.
Description
IQ
Time Frame
yearly for up to 4 years
Title
Bayley Scales of Infant Development
Description
Alternate cognitive test administered to participants who did not achieve basal on WPPSI-III
Time Frame
yearly for up to 4 years
Secondary Outcome Measure Information:
Title
Merrill-Palmer Scale of Mental Tests
Description
Nonverbal cognitive skills
Time Frame
yearly for up to 4 years
Title
Reynell Developmental Language Scales
Description
Language comprehension and expressive language
Time Frame
yearly for up to 4 years
Title
Vineland Adaptive Behavior Scales - Survey Edition
Description
Parent interview on child's adaptive functioning
Time Frame
yearly for up to 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tristram Smith, Ph.D.
Organizational Affiliation
University of Rochester
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
16685181
Citation
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.
Results Reference
result
PubMed Identifier
16212446
Citation
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.
Results Reference
result
PubMed Identifier
19933766
Citation
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.
Results Reference
result
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Randomized Study of Intensive One-on-one Behavioral Treatment for Preschool Aged Children With Autism
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