Clinical trial NCT00004449: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Disorder
Keywords: autism
neurologic and psychiatric disorders
rare disease
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 1999-10-19
Enrollment: 102
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Wechsler Preschool and Primary Scales of Intelligence, 3rd ed.
timeFrame: yearly for up to 4 years
measure: Bayley Scales of Infant Development
timeFrame: yearly for up to 4 years
Secondary outcomes:
measure: Merrill-Palmer Scale of Mental Tests
timeFrame: yearly for up to 4 years
measure: Reynell Developmental Language Scales
timeFrame: yearly for up to 4 years
measure: Vineland Adaptive Behavior Scales - Survey Edition
timeFrame: yearly for up to 4 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Tristram Smith, Ph.D.
role: STUDY_DIRECTOR
References:
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.
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.
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.