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

This study has been completed.
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00004449
First received: October 18, 1999
Last updated: December 13, 2013
Last verified: November 2005

October 18, 1999
December 13, 2013
May 1998
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Complete list of historical versions of study NCT00004449 on ClinicalTrials.gov Archive Site
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Randomized Study of Intensive One-on-one Behavioral Treatment Versus Individualized Parent Training in Preschool Aged Children With Autism
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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.

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.

Interventional
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Allocation: Randomized
Primary Purpose: Treatment
Autistic Disorder
  • Behavioral: intensive one-on-one behavioral treatment
  • Behavioral: Individualized in home parent training
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
November 1999
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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)
Both
2 Years to 3 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004449
R01 MH48863, UCLA-HSPC-G930506611, R01 MH48863
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National Institute of Mental Health (NIMH)
University of California, Los Angeles
Study Chair: Ole Ivar Lovaas University of California, Los Angeles
National Institute of Mental Health (NIMH)
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP