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

Autistic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004449
• Other study ID #: R01MH048863
• Secondary ID: R01MH048863UCLA-
• Status: Completed
• Phase: N/A
• First received: October 18, 1999
• Last updated: May 26, 2015
• Start date: May 1998
• Est. completion date: April 2006

Study information

• Verified date: May 2015
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 2006
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 3 Years

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder

Intervention

Behavioral:
• intensive one-on-one behavioral treatment
Up to 40 hours per week of one-to-one intervention based on applied behavior analysis
• Individualized in home parent training
Offered to subjects at some sites, involved 3+ months of individualized training for parents on applied behavior analysis intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Mental Health (NIMH)

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wechsler Preschool and Primary Scales of Intelligence, 3rd ed.	IQ	yearly for up to 4 years	No
Primary	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	No
Secondary	Merrill-Palmer Scale of Mental Tests	Nonverbal cognitive skills	yearly for up to 4 years	No
Secondary	Reynell Developmental Language Scales	Language comprehension and expressive language	yearly for up to 4 years	No
Secondary	Vineland Adaptive Behavior Scales - Survey Edition	Parent interview on child's adaptive functioning	yearly for up to 4 years	No