Online Pivotal Response Treatment Training in Autism Spectrum Disorder

NCT ID: NCT06523387

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-12-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pivotal Response Treatment Online (PRT-O) Course

Intervention Type: BEHAVIORAL

Pivotal Response Treatment - Parent Training

Delayed Treatment Group (DTG)

No intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pivotal Response Treatment Online (PRT-O) Course

Pivotal Response Treatment - Parent Training

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Grace Gengoux

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grace Gengoux, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Central Contacts

Estefania Millan, MA

Role: CONTACT

autismdd@stanford.edu

(650) 736-1235

Other Identifiers

IRB-73856

Identifier Type: -

Identifier Source: org_study_id