Randomized Study of Intensive One-on-one Behavioral Treatment for Preschool Aged Children With Autism
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|ClinicalTrials.gov Identifier: NCT00004449|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : May 27, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Autistic Disorder||Behavioral: intensive one-on-one behavioral treatment Behavioral: Individualized in home parent training||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Study of Intensive One-on-one Behavioral Treatment Versus Individualized Parent Training in Preschool Aged Children With Autism|
|Study Start Date :||May 1998|
|Actual Primary Completion Date :||September 2004|
|Actual Study Completion Date :||April 2006|
- Behavioral: intensive one-on-one behavioral treatment
Up to 40 hours per week of one-to-one intervention based on applied behavior analysis
- Behavioral: Individualized in home parent training
Offered to subjects at some sites, involved 3+ months of individualized training for parents on applied behavior analysis intervention
- Wechsler Preschool and Primary Scales of Intelligence, 3rd ed. [ Time Frame: yearly for up to 4 years ]IQ
- 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
- Merrill-Palmer Scale of Mental Tests [ Time Frame: yearly for up to 4 years ]Nonverbal cognitive skills
- Reynell Developmental Language Scales [ Time Frame: yearly for up to 4 years ]Language comprehension and expressive language
- Vineland Adaptive Behavior Scales - Survey Edition [ Time Frame: yearly for up to 4 years ]Parent interview on child's adaptive functioning
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004449
|Study Director:||Tristram Smith, Ph.D.||University of Rochester|