Recruiting

PRT-O

Sponsor:

Stanford University

Code:

NCT06523387

Conditions

Autism Spectrum Disorder

Autism

Eligibility Criteria

Sex: All

Age: 2 - 5

Healthy Volunteers: Accepted

Interventions

Pivotal Response Treatment Online (PRT-O) Course

Study Details

Brief summary:

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.

Conditions

Autism Spectrum Disorder

Autism

Study ID

NCT06523387

Start date

Jan 30, 2026

Status verified date

May, 2026

Completion date

Dec 30, 2028

Anticipated

Primary completion date

Dec 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 5

Healthy Volunteers: Accepted

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 Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

no intervention: Delayed Treatment Group (DTG)

No intervention.

Interventions

Pivotal Response Treatment Online (PRT-O) Course

Pivotal Response Treatment - Parent Training

Primary outcome measure

  • Change from Baseline on Parent Fidelity of Pivotal Response Treatment Implementation as measured on the Home Video Observation (HVO) [ Time Frame: 6 Weeks and 12 Weeks ]
  • Change from Baseline on Child Functional Verbal Utterances as measures on the Home Video Observation (HVO) [ Time Frame: 6 Weeks and 12 Weeks ]

Central Contacts and Locations

Central contacts

Jane Huang

(650) 736-1235autismdd@stanford.edu

Estafania Millan, MA

(650) 736-1235autismdd@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305-5719

Contacts

Jane Huang

(650) 736-1235autismdd@stanford.edu

Estefania Millan, MA

(650) 736-1235autismdd@stanford.edu

Principal Investigator:

Grace Gengoux, PhD

More Information

Sponsor

Stanford University

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • Pivotal Response Treatment
  • Parent Training
  • Online Course

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stanford University on 2026-05-19.