Autism Spectrum DisorderPRT-CNCT03778827
A Center Based Study of Pivotal Response Treatment for Preschoolers With Autism
A study testing Intensive Center-Based Pivotal Response Treatment (PRT-C) in people with Autism Spectrum Disorder and Autism, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based environment to treat social communication deficits in children with autism spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 2 to 3 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- Intensive Center-Based Pivotal Response Treatment (PRT-C)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2019to 28 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Autism 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 Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) or Childhood Autism Rating Scale (CARS-2); Diagnostic and Statistical Manual, 5th edition (DSM-5), and expert clinical opinion
- Boys and girls between 2 years and 3 years and 11 months
- Ability to participate in the testing procedures to the extent that valid standard scores can be obtained
- Stable treatment (e.g., applied behavior analysis (ABA), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation
- Developmentally delayed with Mullen Scales of Early Learning (MSEL) or Developmental Profile (DP-4) composite score below 85 (1 Standard Deviation below the mean)
- Availability of at least one English-speaking parent 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.)
- Presence of active medical problem (e.g., unstable seizure disorder or heart disease)
- Child primary language other than English
- Previous adequate trial of Pivotal Response Treatment
- More than 15 hours per week of in-home applied behavior analysis (ABA).
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Center Based Randomized Controlled Trial of Pivotal Response Treatment for Preschoolers With Autism
The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based environment to treat social communication deficits in children with autism spectrum disorder (ASD).
Read the detailed description
The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based preschool environment to treat social communication deficits in children with autism spectrum disorder (ASD). The study will compare Pivotal Response Treatment (PRT) to a delayed treatment group (DTG). PRT is a naturalistic behavioral intervention based on the principles of applied behavior analysis which has shown to be effective in treating the core deficits in children with ASD. The study will compare the combination of parent training with intensive center-based PRT (PRT-C) to a DTG and will include 44 children ages 2 to 3.11 years with ASD and social communication deficits.
- Conditions
- Autism Spectrum Disorder, Autism
- Being tested
- Intensive Center-Based Pivotal Response Treatment (PRT-C)
- Keywords
- Pivotal Response Treatment
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Center-Based Pivotal Response Treatment (PRT-C)Behavioural
Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of weekly individual parent training sessions and center-based therapy for a total of 13 weekly treatment hours.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Center-Based Pivotal Response Treatment (PRT-C) | Experimental | Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of one weekly 60-minute individual parent training session and 12 weekly hours ( 3 hours per day for 4 days per week) with the child in center-based therapy environment for a total of 13 weekly treatment hours. Receives: Behavioral: Intensive Center-Based Pivotal Response Treatment (PRT-C) |
| Delayed Treatment Group (DTG) | No intervention | Delayed Treatment Group will consist of treatment as usual. At the end of controlled phase, participants in the DTG will be offered PRT-C in a preschool setting in an open-label fashion with a design similar to the double-blind phase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from baseline on the Social Responsiveness Scale-2 Total Score at 12 Weeks
Measured: Baseline and Week 12
Mean change from baseline on the Brief Observation of Communication Change (BOSCC) total score at 12 Weeks
Measured: Baseline and Week 12
Mean change from baseline on the frequency if the child's functional utterances on the structured lab observation at 12 Weeks
Measured: Baseline and Week 12
Secondary outcomes (2)
Mean change from baseline on the Vineland Adaptive Behavior Scales 3rd Edition Socialization subscale at 12 Weeks
Measured: Baseline and Week 12
Mean change from baseline on the MacArthur-Bates Communication Development Inventory at 12 Weeks
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start13 May 2019
- Primary completion28 Mar 2026
- Study completion28 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- John & Marcia Goldman Foundation
- Responsible party
- Principal investigator, Antonio Hardan, Stanford University
- Investigators
- Antonio Y. Hardan, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778827
- Sponsor's protocol ID
- IRB-49033
- Acronym
- PRT-C
- Status last verified
- Nov 2026
- First submitted
- 15 Dec 2018
- 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
- A Center Based Randomized Controlled Trial of Pivotal Response Treatment for Preschoolers With Autism
- ClinicalTrials.gov ID
- NCT03778827
- Acronym / sponsor ID
- PRT-C / IRB-49033
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- Pivotal Response Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- John & Marcia Goldman Foundation
- Study start
- 13 May 2019 (actual)
- Primary completion
- 28 Mar 2026 (actual)
- Study completion
- 28 Mar 2026 (actual)
- First posted
- 19 Dec 2018 (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 purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based environment to treat social communication deficits in children with autism spectrum disorder (ASD).
Detailed description
The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based preschool environment to treat social communication deficits in children with autism spectrum disorder (ASD). The study will compare Pivotal Response Treatment (PRT) to a delayed treatment group (DTG). PRT is a naturalistic behavioral intervention based on the principles of applied behavior analysis which has shown to be effective in treating the core deficits in children with ASD. The study will compare the combination of parent training with intensive center-based PRT (PRT-C) to a DTG and will include 44 children ages 2 to 3.11 years with ASD and social communication deficits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Center-Based Pivotal Response Treatment (PRT-C) | Experimental | Behavioral: Intensive Center-Based Pivotal Response Treatment (PRT-C)Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of one weekly 60-minute individual parent training session and 12 weekly hours ( 3 hours per day for 4 days per week) with the child in center-based therapy environment for a total of 13 weekly treatment hours. |
| Delayed Treatment Group (DTG) | No intervention | –Delayed Treatment Group will consist of treatment as usual. At the end of controlled phase, participants in the DTG will be offered PRT-C in a preschool setting in an open-label fashion with a design similar to the double-blind phase. |
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosis of Autism 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 Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) or Childhood Autism Rating Scale (CARS-2); Diagnostic and Statistical Manual, 5th edition (DSM-5), and expert clinical opinion
- Boys and girls between 2 years and 3 years and 11 months
- Ability to participate in the testing procedures to the extent that valid standard scores can be obtained
- Stable treatment (e.g., applied behavior analysis (ABA), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation
- Developmentally delayed with Mullen Scales of Early Learning (MSEL) or Developmental Profile (DP-4) composite score below 85 (1 Standard Deviation below the mean)
Key exclusion criteria (5 listed)
- Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.)
- Presence of active medical problem (e.g., unstable seizure disorder or heart disease)
- Child primary language other than English
- Previous adequate trial of Pivotal Response Treatment
- More than 15 hours per week of in-home applied behavior analysis (ABA).
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 |
|---|---|---|
| Intensive Center-Based Pivotal Response Treatment (PRT-C)Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of weekly individual parent training sessions and center-based therapy for a total of 13 weekly treatment hours. | Behavioural | Intensive Center-Based Pivotal Response Treatment (PRT-C) |
Primary outcome
Mean Change from baseline on the Social Responsiveness Scale-2 Total Score at 12 Weeks
Time frame: Baseline and Week 12
Mean change from baseline on the Brief Observation of Communication Change (BOSCC) total score at 12 Weeks
Time frame: Baseline and Week 12
Mean change from baseline on the frequency if the child's functional utterances on the structured lab observation at 12 Weeks
Time frame: Baseline and Week 12
2 secondary outcomes
Mean change from baseline on the Vineland Adaptive Behavior Scales 3rd Edition Socialization subscale at 12 Weeks
Time frame: Baseline and Week 12
Mean change from baseline on the MacArthur-Bates Communication Development Inventory at 12 Weeks
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. This study is not recruiting at the moment.
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 Intensive Center-Based Pivotal Response Treatment (PRT-C) in people with Autism Spectrum Disorder and Autism, 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 6 inclusion and 5 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from baseline on the Social Responsiveness Scale-2 Total Score at 12 Weeks (time frame: Baseline and Week 12). The study lists 3 primary outcomes in all. 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.