We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004449
First Posted: October 19, 1999
Last Update Posted: May 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Tristram Smith, Ph.D., University of Rochester
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study of Intensive One-on-one Behavioral Treatment Versus Individualized Parent Training in Preschool Aged Children With Autism

Further study details as provided by Tristram Smith, Ph.D., University of Rochester:

Primary Outcome Measures:
  • Wechsler Preschool and Primary Scales of Intelligence, 3rd ed. [ Time Frame: yearly for up to 4 years ]
    IQ

  • Bayley Scales of Infant Development [ Time Frame: yearly for up to 4 years ]
    Alternate cognitive test administered to participants who did not achieve basal on WPPSI-III


Secondary Outcome Measures:
  • Merrill-Palmer Scale of Mental Tests [ Time Frame: yearly for up to 4 years ]
    Nonverbal cognitive skills

  • Reynell Developmental Language Scales [ Time Frame: yearly for up to 4 years ]
    Language comprehension and expressive language

  • Vineland Adaptive Behavior Scales - Survey Edition [ Time Frame: yearly for up to 4 years ]
    Parent interview on child's adaptive functioning


Enrollment: 102
Study Start Date: May 1998
Study Completion Date: April 2006
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: intensive one-on-one behavioral treatment
    Up to 40 hours per week of one-to-one intervention based on applied behavior analysis
    Behavioral: Individualized in home parent training
    Offered to subjects at some sites, involved 3+ months of individualized training for parents on applied behavior analysis intervention
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004449


Sponsors and Collaborators
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Investigators
Study Director: Tristram Smith, Ph.D. University of Rochester
  More Information

Publications:
Responsible Party: Tristram Smith, Ph.D., Professor of Pediatrics, University of Rochester
ClinicalTrials.gov Identifier: NCT00004449     History of Changes
Other Study ID Numbers: R01MH048863 ( U.S. NIH Grant/Contract )
UCLA-HSPC-G930506611
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Tristram Smith, Ph.D., University of Rochester:
autism
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders