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OpenTrials
Completed

NCT Number: NCT00004449

Randomized Study of Intensive One-on-one Behavioral Treatment for 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.

Completed

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Key information

Conditions

Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Disease Attributes Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Signs and Symptoms

Age range

2 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

intensive one-on-one behavioral treatment

Behavioral

Up to 40 hours per week of one-to-one intervention based on applied behavior analysis

Individualized in home parent training

Behavioral

Offered to subjects at some sites, involved 3+ months of individualized training for parents on applied behavior analysis intervention

Primary outcomes

  1. Wechsler Preschool and Primary Scales of Intelligence, 3rd ed.

    Time frame: yearly for up to 4 years

    IQ

  2. 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 outcomes

  1. Merrill-Palmer Scale of Mental Tests

    Time frame: yearly for up to 4 years

    Nonverbal cognitive skills

  2. Reynell Developmental Language Scales

    Time frame: yearly for up to 4 years

    Language comprehension and expressive language

  3. Vineland Adaptive Behavior Scales - Survey Edition

    Time frame: yearly for up to 4 years

    Parent interview on child's adaptive functioning

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
2004
Study completion
2006
First posted
Oct 19, 1999
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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