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

This study has been completed.

First Received: October 18, 1999 Last Updated: November 29, 2005 History of Changes

Sponsors and Collaborators:	National Institute of Mental Health (NIMH) University of California, Los Angeles
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00004449

Purpose

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	Intervention
Autistic Disorder	Behavioral: intensive one-on-one behavioral treatment Behavioral: Individualized in home parent training

MedlinePlus related topics: Autism Child Mental Health Mental Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:	32
Study Start Date:	May 1998
Estimated Study Completion Date:	November 1999

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

Ages Eligible for Study:	2 Years to 3 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY 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

No 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004449

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

University of California, Los Angeles

Investigators

Study Chair:

Ole Ivar Lovaas

University of California, Los Angeles

More Information

No publications provided

Study ID Numbers:	199/13515, UCLA-HSPC-G930506611, R01 MH48863
Study First Received:	October 18, 1999
Last Updated:	November 29, 2005
ClinicalTrials.gov Identifier:	NCT00004449 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

autism
neurologic and psychiatric disorders
rare disease

Study placed in the following topic categories:

Child Development Disorders, Pervasive
Developmental Disabilities
Autistic Disorder
Mental Disorders

Mental Disorders Diagnosed in Childhood
Rare Diseases
Autism

Additional relevant MeSH terms:

Child Development Disorders, Pervasive
Mental Disorders
Autistic Disorder
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on May 07, 2009