AutismPRT-HvCNCT04899544
Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
A study testing Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C) and Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H) in people with Autism and Autism Spectrum Disorder, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder, ASD
- What is being tested?
- Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C) and Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2022to 15 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 (DSM-5), 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University School of Medicine
Stanford, California, 94305
Beatrice Begley, (650)736-1235, PALprogram@stanford.edu
Ellen Choi, (650) 736-1235, PALprogram@stanford.edu
About this study
Official title: Randomized Controlled Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
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).
- Conditions
- Autism, Autism Spectrum Disorder, ASD
- Being tested
- Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C), Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)
- Keywords
- pivotal response treatment, PRT, center based, social and communication
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)Behavioural
Pivotal Response Treatment in autism center.
Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)Behavioural
Pivotal Response Treatment in home environment.
| Study group | Role | What they receive |
|---|---|---|
| Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C) | Experimental | 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. Receives: Behavioral: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C) |
| Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H) | Experimental | 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. Receives: Behavioral: Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H) |
| Treatment As Usual (TAU) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO).
Measured: Baseline,16 Weeks.
Secondary outcomes (6)
Change on MacArthur-Bates Communication Development Inventory (CDI) Scores
Measured: Baseline,16 Weeks.
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores
Measured: Baseline,16 Weeks.
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.
Measured: Baseline,16 Weeks.
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).
Measured: Baseline,16 Weeks.
Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment.
Measured: Baseline,16 Weeks.
Change on the Clinical Global Impressions (CGI) Scale.
Measured: Baseline,16 Weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start18 Oct 2022
- Primary completion15 Sep 2028 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Anonymous Donor
- Responsible party
- Principal investigator, Antonio Hardan, Stanford University
- Investigators
- Antonio Y. Hardan, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899544
- Sponsor's protocol ID
- IRB-61427
- Acronym
- PRT-HvC
- Status last verified
- Nov 2026
- First submitted
- 19 May 2021
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
- ClinicalTrials.gov ID
- NCT04899544
- Acronym / sponsor ID
- PRT-HvC / IRB-61427
- Conditions
- Autism, Autism Spectrum Disorder, ASD
- Keywords
- pivotal response treatment, PRT, center based, social and communication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Anonymous Donor
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C) | Experimental | Behavioral: 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. |
| Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H) | Experimental | Behavioral: 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. |
| Treatment As Usual (TAU) | No intervention | –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. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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 (DSM-5), 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)Pivotal Response Treatment in autism center. | Behavioural | Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C) |
| Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)Pivotal Response Treatment in home environment. | Behavioural | Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H) |
Primary outcome
Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO).
Time frame: Baseline,16 Weeks.
6 secondary outcomes
Change on MacArthur-Bates Communication Development Inventory (CDI) Scores
Time frame: Baseline,16 Weeks.
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores
Time frame: Baseline,16 Weeks.
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) Scores
Time frame: Baseline,16 Weeks.
Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores
Time frame: Baseline,16 Weeks.
Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment.
Time frame: Baseline,16 Weeks.
Change on the Clinical Global Impressions (CGI) Scale.
Time frame: Baseline,16 Weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Y. Hardan, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C) and Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H) in people with Autism and Autism Spectrum Disorder, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beatrice Begley ((650)736-1235, PALprogram@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO). (time frame: Baseline,16 Weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.