Randomized Study of Intensive One-on-one Behavioral Treatment for Preschool Aged Children With Autism

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Study of Intensive One-on-one Behavioral Treatment Versus Individualized Parent Training in Preschool Aged Children With Autism

Conditions
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Autistic Disorder

Intervention / Treatment
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* Behavioral: intensive one-on-one behavioral treatment
* Behavioral: Individualized in home parent training


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wechsler Preschool and Primary Scales of Intelligence, 3rd ed. | IQ | yearly for up to 4 years | 
| Bayley Scales of Infant Development | 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 | Nonverbal cognitive skills | yearly for up to 4 years | 
| Reynell Developmental Language Scales | Language comprehension and expressive language | yearly for up to 4 years | 
| Vineland Adaptive Behavior Scales - Survey Edition | Parent interview on child's adaptive functioning | yearly for up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autism, neurologic and psychiatric disorders, rare disease