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

This study has been completed.
Sponsor:
Collaborator:
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
  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: 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

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   2 Years to 3 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

Sponsors and Collaborators
University of California, Los Angeles
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: R01 MH48863, R01MH048863, UCLA-HSPC-G930506611, R01 MH48863
Study First Received: October 18, 1999
Last Updated: May 26, 2015
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
autism
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on June 01, 2015