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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Tristram Smith, Ph.D., University of Rochester
ClinicalTrials.gov Identifier:
NCT00004449
First received: October 18, 1999
Last updated: May 26, 2015
Last verified: May 2015

October 18, 1999
May 26, 2015
May 1998
September 2004   (final data collection date for primary outcome measure)
  • Wechsler Preschool and Primary Scales of Intelligence, 3rd ed. [ Time Frame: yearly for up to 4 years ] [ Designated as safety issue: No ]
    IQ
  • Bayley Scales of Infant Development [ Time Frame: yearly for up to 4 years ] [ Designated as safety issue: No ]
    Alternate cognitive test administered to participants who did not achieve basal on WPPSI-III
Not Provided
Complete list of historical versions of study NCT00004449 on ClinicalTrials.gov Archive Site
  • Merrill-Palmer Scale of Mental Tests [ Time Frame: yearly for up to 4 years ] [ Designated as safety issue: No ]
    Nonverbal cognitive skills
  • Reynell Developmental Language Scales [ Time Frame: yearly for up to 4 years ] [ Designated as safety issue: No ]
    Language comprehension and expressive language
  • Vineland Adaptive Behavior Scales - Survey Edition [ Time Frame: yearly for up to 4 years ] [ Designated as safety issue: No ]
    Parent interview on child's adaptive functioning
Not Provided
Not Provided
Not Provided
 
Randomized Study of Intensive One-on-one Behavioral Treatment for Preschool Aged Children With Autism
Randomized Study of Intensive One-on-one Behavioral Treatment Versus Individualized Parent Training in Preschool Aged Children With Autism

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
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Autistic Disorder
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
April 2006
September 2004   (final data collection date for primary outcome measure)

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)
Both
2 Years to 3 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00004449
R01MH048863, R01MH048863, UCLA-HSPC-G930506611
No
Not Provided
Not Provided
Tristram Smith, Ph.D., University of Rochester
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Study Director: Tristram Smith, Ph.D. University of Rochester
University of California, Los Angeles
May 2015

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