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RecruitingNCT04899544PRT-HvCUpdated Nov 5, 2026

Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism

An interventional study of Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C) and Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H) in Autism, Autism Spectrum Disorder and ASD, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years later.
Updated Nov 5, 2026Study contact changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
2 Years to 5 Years
Sex
All
01

Study summary

The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).

02

Conditions studied

  • Autism
  • Autism Spectrum Disorder
  • ASD

Keywords

  • pivotal response treatment
  • PRT
  • center based
  • social and communication
03

In context

Autistic Disorder

1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.

This study's planned enrollment of 120 is above the median of 49 across 811 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Browse Stanford University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2), Diagnostic and Statistical Manual 5th Edition (), and expert clinical opinion;
  • Boys and girls between 2.0 and 5.11 years;
  • Ability 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): Standard score at least 1 standard deviation below average for expressive language ability for 2 and 3 year olds; 2 standard deviations for 4 year olds, and 3 standard deviations for 5 year olds;
  • Stable treatment (e.g., Applied Behavior Analysis - ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements;
  • No anticipated changes on treatment during study participation for Center-Based Pivotal Response Treatment (PRT-C) and In-Home Pivotal Response Treatment (PRT-H);
  • No more than 60 minutes of individual 1:1 speech therapy per week;
  • Availability of at least one parent or primary caregiver who can consistently participate in parent training and research measures.

Exclusion criteria

Exclusion Criteria:

  • Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
  • Receiving ABA of 15 hours or more;
  • Presence of active medical problem (e.g., unstable seizure disorder or heart disease);
  • Previous adequate Pivotal Response Treatment (PRT) trial;
  • Participants living more than 30 miles from Stanford University;
  • Child's primary language other than English.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)

    A 16-week center-based PRT intervention (PRT-C) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits.

    Behavioral: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)

  • Experimental
    Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H)

    A 16-week home-based PRT intervention (PRT-H) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits.

    Behavioral: Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)

  • No intervention
    Treatment As Usual (TAU)

    This is a control group that consists of children who are receiving treatment as usual (TAU) for a 16-week period. These families will be invited to participate in PRT after completing the 16-week TAU phase.

Interventions

  • BehavioralCenter-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)

    Pivotal Response Treatment in autism center.

  • BehavioralHome-Based Pivotal Response Treatment (PRT Intervention (PRT-H)

    Pivotal Response Treatment in home environment.

06

What researchers measure

Primary outcomes

  1. Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO).

    Time frame: Baseline,16 Weeks.

Secondary outcomes

  1. Change on MacArthur-Bates Communication Development Inventory (CDI) Scores

    Time frame: Baseline,16 Weeks.

  2. Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores

    Time frame: Baseline,16 Weeks.

  3. Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) Scores

    Social Responsiveness Scale, 2nd Edition (SRS-2) scores measure social abilities with lower scores meaning better social abilities.

    Time frame: Baseline,16 Weeks.

  4. Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores

    Higher Scores on the Stanford Social Dimension Scale mean better social functioning and lower scores mean worse social functioning (Range: 58-290).

    Time frame: Baseline,16 Weeks.

  5. Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment.

    Time frame: Baseline,16 Weeks.

  6. Change on the Clinical Global Impressions (CGI) Scale.

    Time frame: Baseline,16 Weeks.

Other outcomes

  1. Change From Baseline in the Parent Rated General Self Efficacy Scale (GSES) Scores

    Time frame: Baseline,16 Weeks.

  2. Change From Baseline in the Parent Rated Sensory Experiences Questionnaire (SEQ) Scores

    Time frame: Baseline,16 Weeks.

  3. Change From Baseline in the Parent Rated Child and Family Quality of Life - 2 (CFQL-2) Scores

    Time frame: Baseline,16 Weeks.

  4. Change From Baseline in the Parent Rated Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P) Scores

    Time frame: Baseline,16 Weeks.

  5. Change From Baseline in the Parent Rated Family Empowerment Scale (FES) Scores

    Time frame: Baseline,16 Weeks.

  6. Change From Baseline in the Parent Rated Parent Motivation Inventory (PMI) Scores

    Time frame: Baseline,16 Weeks.

  7. Change From Baseline in the Parent Rated Parent Stress Index, Short Form (PSI/SF) Scores

    Time frame: Baseline,16 Weeks.

  8. Change From Baseline in the Parent Rated Dimensional Assessment of Repetitive Behaviors (DARB) Scores

    Time frame: Baseline,16 Weeks.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Secondary outcomes
1 removed
What changed in the outcomes
  • Removedother outcomeChange From Baseline in the Parent Rated Emotion Dysregulation Inventory-Young Child (EDI-YC) ScoresTime frame: Baseline,16 Weeks.
Nov 5, 2026
Contact
Study contact changed: P•••@stanford.edu · •••1235→P•••@stanford.edu · •••1235. See the current contact
Nov 5, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Stanford University School of Medicine · Stanford, United StatesContact P•••@stanford.edu · •••1235→P•••@stanford.edu · •••1235
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Secondary outcomes 1 removed
    What changed in the outcomes
    • Removedother outcomeChange From Baseline in the Parent Rated Emotion Dysregulation Inventory-Young Child (EDI-YC) ScoresTime frame: Baseline,16 Weeks.
    Contact Study contact changed: P•••@stanford.edu · •••1235→P•••@stanford.edu · •••1235. See the current contact
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Stanford University School of Medicine · Stanford, United StatesContact P•••@stanford.edu · •••1235→P•••@stanford.edu · •••1235
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04899544
Lead sponsor
Stanford University
Collaborators
Anonymous Donor
Responsible party
Antonio Hardan (Professor, Stanford University) — Principal investigator
First posted
May 24, 2021
Start date
Oct 18, 2022
Primary completion
Sep 15, 2028 (estimated)
Completion
Sep 15, 2028 (estimated)
Last update
Nov 5, 2026

Study contacts

Beatrice Begley
Contact
PALprogram@stanford.edu
(650)736-1235
Ellen Choi
Contact
PALprogram@stanford.edu
(650)736-1235
Antonio Y. Hardan, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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