Pivotal Response Treatment Package for Young Children With Autism

Completed · Not applicable

Conditions studied: Autism Spectrum Disorder (ASD), Autism

In brief

This is a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism.

Key facts

Study ID

NCT02037022

Run by

Stanford University

People needed

48

Starts

2013-12-04

Expected to finish

2017-07-28

Last updated by the study team

2020-02-25

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview- Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS-2), and expert clinical opinion
• Males and females in good medical health between 2.0 and 5.11 years
• Ability to participate in the testing procedures to the extent that valid standard scores can be obtained
• Language delay as measured by the Preschool Language Scale: Standard score at least 1 Standard Deviation below average for expressive language ability
• Stable treatment, speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation
• No more than 60 minutes of individual 1:1 speech therapy per week
• Availability of at least one parent who can consistently participate in parent training and research measures
• Parents intend on continuing Pivotal Response Treatment Package (PRT-P) for a minimum of 12 weeks
• Parents must be 18 years of age or older

You may not qualify if…

• Current or lifetime diagnosis of severe psychiatric disorder, such as bipolar disorder
• Receiving in-home Applied Behavior Analysis (ABA) of 10 hours or more
• A genetic abnormality, such as Fragile X
• Presence of active medical problem, such as unstable seizure disorder or heart disease
• Previous adequate PRT trial
• Participants living more than 50 miles from Stanford University
• At least one room of the house must be available to be dedicated to treatment during session times
• There must be no serious health and safety risks present in the home environment
• The research team has the right to refuse to perform sessions in-home even if the criteria above are met

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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