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OpenTrials
Completed

NCT Number: NCT01258465

Research in Autism: Parent Intervention

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.

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Key information

Age range

24 month–47 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego Psychology Department, La Jolla, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pivotal Response Training

Behavioral

Naturalistic behavioral protocol designed to teach vocal communication.

Picture Exchange Communication System

Behavioral

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

Primary outcomes

  1. Mullen Scales of Early Learning

    Time frame: 23 weeks with three months follow-up

Secondary outcomes

  1. Vineland Adaptive Behavior Scales

    Time frame: 23 weeks and 3 month follow up

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Dec 13, 2010
Registry last updated
Dec 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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