Research in Autism: Parent Intervention

December 10, 2010 updated by: University of California, San Diego
The purpose of this research project was to systematically compare two widely used types of intervention programs for children with autism within a parent training model. In one condition, randomly assigned children were provided with an intervention that typically results in acquisition of expressive words in a large percentage of children diagnosed as having autism, using a well-documented manualized intervention focused on verbal expressive communication only (Pivotal Response Training, PRT). In the other condi¬tion, randomly assigned children received a widely used intervention on the same social communication functions using a well-documented manualized augmentative system of intervention (Picture Exchange Communica¬tion System, PECS) that has been reported to produce verbal and nonverbal communication in large percentages of children diagnosed with autism. Children in the two conditions were compared for development of verbal and nonverbal communication, changes in disruptive behavior, changes in symptoms of autism, and general adaptive behavior gains. In addition, parent satisfaction and stress measures were gathered in order to assess the effects of each intervention on family functioning.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093-0109
        • University of California, San Diego Psychology Department
      • Santa Barbara, California, United States, 93108
        • University of California, Santa Barbara, School of Education, Department of Clinical, Counseling, and School Psychology

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Autistic Disorder or At Risk of Autistic Disorder
  • Age 2-0 to 3-11 years of age
  • Use of fewer than 10 functional words at intake

Exclusion Criteria:

  • Primary diagnosis of mental retardation
  • Neurologic pathology (e.g., PKU, encephalitis, brain trauma)
  • Major sensory impairment

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pivotal Response Training
A naturalistic behavioral intervention designed to facilitate verbal communication.
Behavioral: Pivotal Response Training
Naturalistic behavioral protocol designed to teach vocal communication.
Behavioral: Picture Exchange Communication System
Pictorially-based behavioral protocol designed to teach communication to nonverbal children via pictures icons.
Active Comparator: Picture Exchange Communication System
Pictorially-based behavioral protocol designed to facilitate communication via picture icons.
Behavioral: Picture Exchange Communication System
Pictorially-based behavioral protocol designed to teach communication to nonverbal children via pictures icons.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mullen Scales of Early Learning
Time Frame: 23 weeks with three months follow-up
23 weeks with three months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Vineland Adaptive Behavior Scales
Time Frame: 23 weeks and 3 month follow up
23 weeks and 3 month follow up

Collaborators and Investigators

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

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Laura E Schreibman, Ph.D., University of California, San Diego
  • Principal Investigator: Robert L Koegel, Ph.D., University of California, Santa Barbara

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

January 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 10, 2010

First Submitted That Met QC Criteria

December 10, 2010

First Posted (Estimate)

December 13, 2010

Study Record Updates

Last Update Posted (Estimate)

December 13, 2010

Last Update Submitted That Met QC Criteria

December 10, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH39434

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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