Autistic Disorder
Conditions
Keywords
autism, neurologic and psychiatric disorders, rare disease
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.
Interventions
BEHAVIORALintensive one-on-one behavioral treatment
Up to 40 hours per week of one-to-one intervention based on applied behavior analysis
BEHAVIORALIndividualized in home parent training
Offered to subjects at some sites, involved 3+ months of individualized training for parents on applied behavior analysis intervention
Sponsors
National Institute of Mental Health (NIMH)
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 3 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wechsler Preschool and Primary Scales of Intelligence, 3rd ed. | yearly for up to 4 years | IQ |
| Bayley Scales of Infant Development | yearly for up to 4 years | Alternate cognitive test administered to participants who did not achieve basal on WPPSI-III |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Merrill-Palmer Scale of Mental Tests | yearly for up to 4 years | Nonverbal cognitive skills |
| Reynell Developmental Language Scales | yearly for up to 4 years | Language comprehension and expressive language |
| Vineland Adaptive Behavior Scales - Survey Edition | yearly for up to 4 years | Parent interview on child's adaptive functioning |
Outcome results
None listed