NCT01258465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2010

Completed
Last Updated

December 13, 2010

Status Verified

December 1, 2010

Enrollment Period

4.9 years

First QC Date

December 10, 2010

Last Update Submit

December 10, 2010

Conditions

Keywords

CommunicationPivotal Response TrainingPicture Exchange Communication System

Outcome Measures

Primary Outcomes (1)

  • Mullen Scales of Early Learning

    23 weeks with three months follow-up

Secondary Outcomes (1)

  • Vineland Adaptive Behavior Scales

    23 weeks and 3 month follow up

Study Arms (2)

Pivotal Response Training

ACTIVE COMPARATOR

A naturalistic behavioral intervention designed to facilitate verbal communication.

Behavioral: Pivotal Response TrainingBehavioral: Picture Exchange Communication System

Picture Exchange Communication System

ACTIVE COMPARATOR

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

Behavioral: Picture Exchange Communication System

Interventions

Naturalistic behavioral protocol designed to teach vocal communication.

Pivotal Response Training

Pictorially-based behavioral protocol designed to teach communication to nonverbal children via pictures icons.

Picture Exchange Communication SystemPivotal Response Training

Eligibility Criteria

Age24 Months - 47 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Diego Psychology Department

La Jolla, California, 92093-0109, United States

Location

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

Santa Barbara, California, 93108, United States

Location

MeSH Terms

Conditions

Autistic DisorderCommunication

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Study Officials

  • Laura E Schreibman, Ph.D.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR
  • Robert L Koegel, Ph.D.

    University of California, Santa Barbara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 2010

First Posted

December 13, 2010

Study Start

January 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 13, 2010

Record last verified: 2010-12

Locations