Research in Autism: Parent Intervention - Full Text View

Purpose

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.

Condition	Intervention
Autistic Disorder	Behavioral: Pivotal Response Training Behavioral: Picture Exchange Communication System

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Research in Autism: Parent Intervention

Resource links provided by NLM:

MedlinePlus related topics: Autism

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

Mullen Scales of Early Learning [ Time Frame: 23 weeks with three months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Vineland Adaptive Behavior Scales [ Time Frame: 23 weeks and 3 month follow up ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	January 2005
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	24 Months to 47 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258465

Locations

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

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	Laura Schreibman, Ph.D., University of California, San Diego
ClinicalTrials.gov Identifier:	NCT01258465 History of Changes
Other Study ID Numbers:	MH39434
Study First Received:	December 10, 2010
Last Updated:	December 10, 2010
Health Authority:	United States: Federal Government

Keywords provided by University of California, San Diego:

Communication
Pivotal Response Training
Picture Exchange Communication System

Additional relevant MeSH terms:

Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013