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

Randomized Controlled Trial of an Online Pivotal Response Treatment Training in Autism Spectrum Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Behavioral: Pivotal Response Treatment Online (PRT-O) Course

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jane Huang; Phone Number: (650) 736-1235; Email: autismdd@stanford.edu
• Study Contact Backup: Name: Estafania Millan, MA; Phone Number: (650) 736-1235; Email: autismdd@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305-5719
      • Recruiting
      • Stanford University
      • Contact: Estefania Millan, MA; Phone Number: (650) 736-1235; Email: autismdd@stanford.edu
      • Principal Investigator: Grace Gengoux, PhD
      • Contact: Jane Huang; Phone Number: (650) 736-1235; Email: autismdd@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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
• living within 100 miles of Stanford University.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pivotal Response Treatment Online (PRT-O) Course; 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.	Behavioral: Pivotal Response Treatment Online (PRT-O) Course; Pivotal Response Treatment - Parent Training
No Intervention: Delayed Treatment Group (DTG); No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline on Parent Fidelity of Pivotal Response Treatment Implementation as measured on the Home Video Observation (HVO)	Parent Fidelity of Pivotal Response Treatment Implementation will be rated from 10 min HVO by trained coders naïve to treatment assignment and timepoint using established operational definitions from prior PRT studies (e.g., Hardan et al., 2015; Gengoux et al., 2019).	6 Weeks and 12 Weeks
Change from Baseline on Child Functional Verbal Utterances as measures on the Home Video Observation (HVO)	Child Functional Verbal Utterances will be rated from 10 min HVO by trained coders naïve to treatment assignment and timepoint using established operational definitions from prior PRT studies (e.g., Hardan et al., 2015; Gengoux et al., 2019).	6 Weeks and 12 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline on the Clinical Global Impression Scales (CGI)	6 Weeks and 12 Weeks
Change from Baseline on the Vineland Adaptive Behavior Scales -3 (VABS-3) Communication Domain	12 Weeks
Change from Baseline on the MacArthur-Bates Communication Scales (CDI)	12 Weeks

Other Outcome Measures

Outcome Measure	Time Frame
Change from Baseline on the Stanford Social Dimension Scale (SSDS)	12 Weeks
Change from Baseline on the Dimensional Assessment of Repetitive Behavior Scale (DARB)	12 Weeks
Change from Baseline on the Neurobehavioral Evaluation (NET) Tool	12 Weeks
Change from Baseline on the EQ-5D-Y-5L	12 Weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Grace Gengoux, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Parent Training; Pivotal Response Treatment; Online Course
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: IRB-73856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No