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Research in Autism: Parent Intervention

Primary Purpose

Autistic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pivotal Response Training
Picture Exchange Communication System
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorder focused on measuring Communication, Pivotal Response Training, Picture Exchange Communication System

Eligibility Criteria

24 Months - 47 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Diego Psychology Department
  • University of California, Santa Barbara, School of Education, Department of Clinical, Counseling, and School Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pivotal Response Training

Picture Exchange Communication System

Arm Description

A naturalistic behavioral intervention designed to facilitate verbal communication.

Pictorially-based behavioral protocol designed to facilitate communication via picture icons.

Outcomes

Primary Outcome Measures

Mullen Scales of Early Learning

Secondary Outcome Measures

Vineland Adaptive Behavior Scales

Full Information

First Posted
December 10, 2010
Last Updated
December 10, 2010
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01258465
Brief Title
Research in Autism: Parent Intervention
Official Title
Research in Autism: Parent Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
Communication, Pivotal Response Training, Picture Exchange Communication System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pivotal Response Training
Arm Type
Active Comparator
Arm Description
A naturalistic behavioral intervention designed to facilitate verbal communication.
Arm Title
Picture Exchange Communication System
Arm Type
Active Comparator
Arm Description
Pictorially-based behavioral protocol designed to facilitate communication via picture icons.
Intervention Type
Behavioral
Intervention Name(s)
Pivotal Response Training
Intervention Description
Naturalistic behavioral protocol designed to teach vocal communication.
Intervention Type
Behavioral
Intervention Name(s)
Picture Exchange Communication System
Intervention Description
Pictorially-based behavioral protocol designed to teach communication to nonverbal children via pictures icons.
Primary Outcome Measure Information:
Title
Mullen Scales of Early Learning
Time Frame
23 weeks with three months follow-up
Secondary Outcome Measure Information:
Title
Vineland Adaptive Behavior Scales
Time Frame
23 weeks and 3 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
47 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura E Schreibman, Ph.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert L Koegel, Ph.D.
Organizational Affiliation
University of California, Santa Barbara
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego Psychology Department
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0109
Country
United States
Facility Name
University of California, Santa Barbara, School of Education, Department of Clinical, Counseling, and School Psychology
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93108
Country
United States

12. IPD Sharing Statement

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Research in Autism: Parent Intervention

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