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Online Pivotal Response Treatment Training in Autism Spectrum Disorder

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06523387
Acronym
PRT-O
Enrollment
44
Registered
2024-07-26
Start date
2026-01-30
Completion date
2028-12-30
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism, Autism Spectrum Disorder

Keywords

Pivotal Response Treatment, Parent Training, Online Course

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.

Interventions

BEHAVIORALPivotal Response Treatment Online (PRT-O) Course

Pivotal Response Treatment - Parent Training

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline on Parent Fidelity of Pivotal Response Treatment Implementation as measured on the Home Video Observation (HVO)6 Weeks and 12 WeeksParent 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).
Change from Baseline on Child Functional Verbal Utterances as measures on the Home Video Observation (HVO)6 Weeks and 12 WeeksChild 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).

Secondary

MeasureTime 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 Domain12 Weeks
Change from Baseline on the MacArthur-Bates Communication Scales (CDI)12 Weeks

Countries

United States

Contacts

CONTACTJane Huang
autismdd@stanford.edu(650) 736-1235
CONTACTEstafania Millan, MA
autismdd@stanford.edu(650) 736-1235
PRINCIPAL_INVESTIGATORGrace Gengoux, PhD

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026