Online Pivotal Response Treatment Training in Autism Spectrum Disorder

NCT06523387 | Recruiting

• 1 other identifier: IRB-73856
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

Pivotal Response Treatment; Parent Training; Online Course

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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 Outcomes (4)

• Change from Baseline on the Stanford Social Dimension Scale (SSDS)

  12 Weeks

• Change from Baseline on the Parent Stress Index (PSI)

  12 Weeks

• Change from Baseline on the Dimensional Assessment of Repetitive Behavior Scale (DARB)

  12 Weeks

Study Arms (2)

Pivotal Response Treatment Online (PRT-O) Course

EXPERIMENTAL

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

Delayed Treatment Group (DTG)

NO INTERVENTION

No intervention.

Interventions

Pivotal Response Treatment Online (PRT-O) Course BEHAVIORAL

Pivotal Response Treatment - Parent Training

Pivotal Response Treatment Online (PRT-O) Course

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• :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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305-5719, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Grace Gengoux, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Estefania Millan, MA

CONTACT

(650) 736-1235; autismdd@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 26, 2024
• Study Start: January 30, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)