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NCT Number: NCT06523387

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.

Recruiting

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Key information

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pivotal Response Treatment Online (PRT-O) Course

Behavioral

Pivotal Response Treatment - Parent Training

Primary outcomes

  1. 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

    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).

  2. Change from Baseline on Child Functional Verbal Utterances as measures on the Home Video Observation (HVO)

    Time frame: 6 Weeks and 12 Weeks

    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).

Secondary outcomes

  1. Change from Baseline on the Clinical Global Impression Scales (CGI)

    Time frame: 6 Weeks and 12 Weeks

  2. Change from Baseline on the Vineland Adaptive Behavior Scales -3 (VABS-3) Communication Domain

    Time frame: 12 Weeks

  3. Change from Baseline on the MacArthur-Bates Communication Scales (CDI)

    Time frame: 12 Weeks

Other outcomes

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

    Time frame: 12 Weeks

  2. Change from Baseline on the EQ-5D-Y-5L

    Time frame: 12 Weeks

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

    Time frame: 12 Weeks

  4. Change from Baseline on the Neurobehavioral Evaluation (NET) Tool

    Time frame: 12 Weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Estafania Millan, MA

CONTACT

[email protected]

(650) 736-1235

Jane Huang

CONTACT

[email protected]

(650) 736-1235

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: PRT-O

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 26, 2024
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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