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

May 26, 2015 updated by: Tristram Smith, Ph.D., University of California, Los Angeles

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.

Study Overview

Status

Completed

Conditions

Autistic Disorder

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 3 years (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wechsler Preschool and Primary Scales of Intelligence, 3rd ed. Time Frame: yearly for up to 4 years	IQ	yearly for up to 4 years
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	yearly for up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Merrill-Palmer Scale of Mental Tests Time Frame: yearly for up to 4 years	Nonverbal cognitive skills	yearly for up to 4 years
Reynell Developmental Language Scales Time Frame: yearly for up to 4 years	Language comprehension and expressive language	yearly for up to 4 years
Vineland Adaptive Behavior Scales - Survey Edition Time Frame: yearly for up to 4 years	Parent interview on child's adaptive functioning	yearly for up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute of Mental Health (NIMH)

Investigators

Study Director: Tristram Smith, Ph.D., University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1998

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

October 18, 1999

First Submitted That Met QC Criteria