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Online Pivotal Response Treatment Training in Autism Spectrum Disorder (PRT-O)

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Stanford University

Status

Not yet enrolling

Conditions

Autism Spectrum Disorder
Autism

Treatments

Behavioral: Pivotal Response Treatment Online (PRT-O) Course

Study type

Interventional

Funder types

Other

Identifiers

NCT06523387
IRB-73856

Details and patient eligibility

About

This is a research study that will assess the effects of a Pivotal Response Treatment Online Training Course (PRT-O) for training parents of children with Autism Spectrum Disorder (ASD). The study will specifically investigate whether participants can learn to deliver PRT effectively following participation in the Online training.

Enrollment

44 estimated patients

Sex

All

Ages

2 to 5 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 2:0 to 5:11 years at the time of consent,
  • diagnosed with ASD (based on history, review of available medical records including diagnostic testing, e.g., Autism Diagnostic Observation Schedule) or suspicion of Autism Spectrum Disorder diagnosis, and confirmed with Autism Diagnostic Interview-Revised (ADI-R),
  • with significant adaptive communication deficits (i.e., either a Vineland-3 Communication subscale 2 Standard Deviations below average for 2 and 3 year olds and 3 Standard Deviations below for 4 and 5 year olds or a Vineland-3 Expressive V-scale Score 2 Standard Deviations below average for 2 and 3 year olds, or 3 Standard Deviations below for 4 and 5 year old, and at least moderate severity on the Clinical Global Impressions Severity (CGI-S) language subscale),
  • an English-speaking parent able to consistently participate in study procedures and conduct treatment in English,
  • stable psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation,
  • stable treatment (ABA, Floortime, or other interventions), speech therapy, and school placement for at least 1 month prior to baseline measurements with no expected changes during study participation,
  • no more than 60 minutes of 1:1 speech therapy per week

Exclusion criteria

  • Children who have a primary language other than English
  • parent or child diagnosed with severe psychiatric disorder or unstable medical problem
  • previous adequate trial of pivotal response treatment resulting in parent meeting Pivotal Response Treatment fidelity of implementation at baseline
  • Receiving more than 15 hours of in home 1:1 ABA per week

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

44 participants in 2 patient groups

Pivotal Response Treatment Online (PRT-O) Course
Experimental group
Description:
The PRT-O Online Course (PRT-O) will consist of 10 online lessons completed asynchronously through the Stanford LearnMed Online CANVAS Platform. Parents are expected to view the 10 lessons over the course of a 12-week study period, complete worksheets, and to practice PRT at home.
Treatment:
Behavioral: Pivotal Response Treatment Online (PRT-O) Course
Delayed Treatment Group (DTG)
No Intervention group
Description:
No intervention.

Trial contacts and locations

1

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Central trial contact

Estefania Millan, MA

Data sourced from clinicaltrials.gov

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