Autism Spectrum DisorderPRT-INCT03583684
Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
A study testing Pivotal Response Treatment Program (PRT-P) in people with Autism Spectrum Disorder and Autism, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- Pivotal Response Treatment Program (PRT-P)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2018to 30 Nov 2027
- 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 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
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
Stanford, California, 94305-5719
Estefania Millan, MA, (650) 736-1235, mmillan2@stanford.edu
Robin Libove, BS, (650) 736-1235, rlibove@stanford.edu
About this study
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
- Being tested
- Pivotal Response Treatment Program (PRT-P)
- Keywords
- Pivotal Response Treatment, Imaging
- 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.
Pivotal Response Treatment Program (PRT-P)Behavioural
Also called Pivotal Response Treatment
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.
| Study group | Role | What they receive |
|---|---|---|
| Pivotal Response Treatment Program (PRT-P) | Experimental | 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. Receives: Behavioral: Pivotal Response Treatment Program (PRT-P) |
| Delayed Treatment Group (DTG) | No intervention | Child continues stable treatments as usual in the community. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Child Utterances During a Structured Lab Observation (SLO)
Measured: Baseline, 16 Weeks
Secondary outcomes (1)
Change on MacArthur-Bates Communication Development Inventory (CDI)
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 posted11 Jul 2018
- Study start7 Dec 2018
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Antonio Hardan, Stanford University
- Investigators
- Antonio Hardan, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583684
- Sponsor's protocol ID
- IRB-46131
- Other IDs
- 1R21DC016089-01A1
- Acronym
- PRT-I
- Status last verified
- Nov 2026
- First submitted
- 13 Jun 2018
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will submit de-identified clinical data to the NIMH Data Archive (NDA) data repository.
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
- Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
- ClinicalTrials.gov ID
- NCT03583684
- Acronym / sponsor ID
- PRT-I / IRB-46131
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- Pivotal Response Treatment, Imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 11 Jul 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pivotal Response Treatment Program (PRT-P) | Experimental | Behavioral: 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. |
| Delayed Treatment Group (DTG) | No intervention | –Child continues stable treatments as usual in the community. |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Pivotal Response Treatment Program (PRT-P)Also: Pivotal Response TreatmentThe 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. | Behavioural | Pivotal Response Treatment Program (PRT-P) |
Primary outcome
Change in Number of Child Utterances During a Structured Lab Observation (SLO)
Time frame: Baseline, 16 Weeks
1 secondary outcome
Change on MacArthur-Bates Communication Development Inventory (CDI)
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: Yes. We will submit de-identified clinical data to the NIMH Data Archive (NDA) data repository.
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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 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 Pivotal Response Treatment Program (PRT-P) 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 10 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 Estefania Millan, MA ((650) 736-1235, mmillan2@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 a 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.