Recruiting

Pivotal Response Treatment

Sponsor:

Stanford University

Code:

NCT03583684

Conditions

Autism Spectrum Disorder

Autism

Eligibility Criteria

Sex: All

Age: 2 - 4

Healthy Volunteers: Not accepted

Interventions

Pivotal Response Treatment Program (PRT-P)

Study Details

Brief summary:

Autism spectrum disorder (ASD) is a very heterogeneous disorder with limited empirically validated behavioral and biological interventions. The goal of this pilot investigation is to apply a biologically-based approach to identify predictors of treatment response in children with ASD who are receiving Pivotal Response Treatment (PRT), an evidence-based behavioral intervention. Specifically, the investigators propose to identify neuroimaging biomarkers of treatment response to a PRT program (PRT-P) targeting language deficits in young children with ASD who will be randomized to either PRT-P or to a delayed treatment group (DTG).

Conditions

Autism Spectrum Disorder

Autism

Study ID

NCT03583684

Start date

Dec 7, 2018

Status verified date

Nov, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 4

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of Autism Spectrum Spectrum Disorder (ASD) based on clinical interview and Diagnostic and Statistical Manual, 5th edition (DSM-5) and confirmed using the Autism Diagnostic Interview Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS) and/or Brief Observation of Symptoms of Autism (BOSA) and/or Childhood Autism Rating Scale- Second Edition (CARS-2).
  • Outpatients between 2.0 and 4.11 years of age of either gender,
  • Children of all cognitive levels will be included as long as they are able to participate in the testing procedures to the extent that valid standard scores can be obtained
  • Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5) \[at least 1 standard deviation behind for children age 2 and 3 years; and 2 standard deviations behind for children age 4\],
  • 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 \[Applied Behavior Analysis (ABA), Floortime, or other interventions\], 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,
  • The child's exposure to the English language must be sufficient that administration of standardized tests in English is appropriate for measuring progress,
  • The availability of at least one parent who can consistently participate in the training sessions and related activities, and
  • Successful completion of baseline brain scan.

Exclusion Criteria:

  • Current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder),
  • Genetic abnormality (e.g., Fragile X)
  • Presence of active medical problem (e.g., unstable seizure disorder),
  • Receiving more than 15 hours of in home 1:1 Applied Behavior Analysis (ABA) per week
  • Magnetic Resonance (MR) contraindication (e.g., the presence of ferrous metal), or
  • Previous adequate Pivotal Response Treatment (PRT) trial.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pivotal Response Treatment Program (PRT-P)

The Pivotal Response Treatment Program (PRT-P) will consist of 3 parent-only sessions (60-90 min) and 13 family sessions with the parent and child (60-90 min). These 16 sessions are once per week over a 16 week period.

no intervention: Delayed Treatment Group (DTG)

Child continues stable treatments as usual in the community.

Interventions

Pivotal Response Treatment Program (PRT-P)

The Pivotal Response Treatment Program (PRT-P) will consist of 3 parent-only sessions (60-90 min) and 13 family sessions with the parent and child (60-90 min). These 16 sessions are once per week over a 16 week period.

Primary outcome measure

  • Change in Number of Child Utterances During a Structured Lab Observation (SLO) [ Time Frame: Baseline, 16 Weeks ]

Central Contacts and Locations

Central contacts

Estefania Millan, MA

(650) 736-1235mmillan2@stanford.edu

John Hegarty, PhD

(650) 736-1235hegartyj@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305-5719

Contacts

Estefania Millan, MA

(650) 736-1235mmillan2@stanford.edu

Robin Libove, BS

(650) 736-1235rlibove@stanford.edu

Principal Investigator:

Antonio Y. Hardan, MD

More Information

Sponsor

Stanford University

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • Pivotal Response Treatment
  • Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-11-10.