Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Research in Autism: Parent Intervention

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01258465
First received: December 10, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on November 24, 2014