Autism Spectrum DisorderPRT-OSNCT06690255
Trial of an Online Spanish Pivotal Response Treatment Training in Autism Spectrum Disorder
A study testing Pivotal Response Treatment in people with Autism Spectrum Disorder, run by Stanford University at 1 site in United States.
Trial summary
The goal of this clinical trial is to understand if an online course in Spanish can help Spanish-speaking parents use Pivotal Response Treatment (PRT) to support language and social skills in young children with Autism Spectrum Disorder (ASD). Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Pivotal Response Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2026to 15 Dec 2030
- 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
- Children aged 2 to 5 years, 11 months at the time of consent
- Diagnosis of Autism Spectrum Disorder (ASD), confirmed through medical records and/or parent questionnaire
- Significant language delay, indicated by scores 2 standard deviations (SD) below the average for ages 2 and 3, or 3 SD below the average for ages 4 and 5 on the Vineland-3 Communication subscale or Expressive V-scale
- A Spanish-speaking parent or primary caregiver available to consistently participate in study activities and implement PRT in Spanish
- Stable on any psychotropic medications or biomedical interventions for at least 1 month before baseline, with no anticipated changes during the study
- Consistent treatment or intervention services (such as ABA, Floortime, or speech therapy) and stable school placement for at least 1 month before baseline, with no expected changes
- Limited to no more than 60 minutes of one-on-one speech therapy per week
Who cannot join
- Primary language of the child or parent is not Spanish
- Either the child or parent has a severe psychiatric disorder or an unstable medical condition
- Prior exposure to or adequate trial of Pivotal Response Treatment, resulting in the parent achieving fidelity in PRT implementation at baseline
- The child is currently receiving more than 15 hours of one-on-one Applied Behavior Analysis (ABA) therapy per week
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ty Vernon, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94305
Robin Libove, 650-736-1235, autismdd@stanford.edu
Grace Gengoux, PhD
About this study
Official title: Trial of an Online Spanish Pivotal Response Treatment Training in Autism Spectrum Disorder (PRT-OS)
The goal of this clinical trial is to understand if an online course in Spanish can help Spanish-speaking parents use Pivotal Response Treatment (PRT) to support language and social skills in young children with Autism Spectrum Disorder (ASD). This study aims to reach families who may have trouble accessing autism services due to language, location, or cost barriers. The main questions it hopes to answer are:
- Can Spanish-speaking parents learn to effectively use PRT techniques to support their child's communication?
- Does this training improve children's language and social interactions?
Read more
Researchers will evaluate the effectiveness of the online course for parents who participate in regular virtual check-ins and submit videos showing their practice with PRT.
Participants in the study will:
- Complete online lessons over 12 weeks that teach PRT methods, specifically designed for Spanish-speaking parents
- Meet with a research team member every few weeks by phone or video to ask questions and receive feedback
- Provide video recordings of interactions with their child to track progress
- Complete brief surveys about their experience and child's communication abilities
By focusing on Spanish-speaking families, this study aims to increase access to effective autism support and reduce gaps in care. Researchers hope the findings will help develop better resources for families facing similar barriers and improve language and social outcomes for children with autism.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Pivotal Response Treatment
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pivotal Response TreatmentBehavioural
PRT will target functional communication abilities
| Study group | Role | What they receive |
|---|---|---|
| Spanish PRT Online | Experimental | Participating parents will receive access to a 12-week online course designed to teach Pivotal Response Treatment (PRT) strategies in Spanish. The course includes 10 instructional lessons and check-ins with a researcher via secure videoconference. Receives: Behavioral: Pivotal Response Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parent Fidelity of PRT Implementation from Baseline to Week 12
Based on behavioral coding of parent-child interaction videos in the home
Measured: Baseline, Week 12
Secondary outcomes (4)
Change in Child Frequency of Functional Utterances from Baseline to Week 12
Based on behavioral coding of parent-child interaction videos in the home and parent report measures
Measured: Baseline, Week 12
Change in Child Frequency of Functional Utterances from Baseline to Week 12
Based on parent-report on the MacArthur-Bates Communicative Development Inventories
Measured: Baseline, Week 12
Change in Child Socialization and Communication from Baseline to Week 12
Based on clinician-rated Clinical Global Impressions Scale (CGI)
Measured: Baseline, Week 12
Change in Child Socialization and Communication from Baseline to Week 12
Based on parent-rated Vineland Adaptive Behavior Scale, Third Edition (VABS-3)
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start17 Jun 2026
- Primary completion15 Dec 2029 (estimated)
- Study completion15 Dec 2030 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Santa Barbara
- Responsible party
- Principal investigator, Grace Gengoux, Stanford University
- Investigators
- Grace Gengoux, Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690255
- Sponsor's protocol ID
- IRB-77671
- Acronym
- PRT-OS
- Status last verified
- Jun 2026
- First submitted
- 13 Nov 2024
- Last updated
- 22 Jun 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of an Online Spanish Pivotal Response Treatment Training in Autism Spectrum Disorder (PRT-OS)
- ClinicalTrials.gov ID
- NCT06690255
- Acronym / sponsor ID
- PRT-OS / IRB-77671
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of California, Santa Barbara
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 15 Dec 2029 (estimated)
- Study completion
- 15 Dec 2030 (estimated)
- First posted
- 15 Nov 2024 (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 goal of this clinical trial is to understand if an online course in Spanish can help Spanish-speaking parents use Pivotal Response Treatment (PRT) to support language and social skills in young children with Autism Spectrum Disorder (ASD). This study aims to reach families who may have trouble accessing autism services due to language, location, or cost barriers. The main questions it hopes to answer are:
- Can Spanish-speaking parents learn to effectively use PRT techniques to support their child's communication?
- Does this training improve children's language and social interactions?
Researchers will evaluate the effectiveness of the online course for parents who participate in regular virtual check-ins and submit videos showing their practice with PRT.
Participants in the study will:
- Complete online lessons over 12 weeks that teach PRT methods, specifically designed for Spanish-speaking parents
- Meet with a research team member every few weeks by phone or video to ask questions and receive feedback
- Provide video recordings of interactions with their child to track progress
- Complete brief surveys about their experience and child's communication abilities
By focusing on Spanish-speaking families, this study aims to increase access to effective autism support and reduce gaps in care. Researchers hope the findings will help develop better resources for families facing similar barriers and improve language and social outcomes for children with autism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spanish PRT Online | Experimental | Behavioral: Pivotal Response TreatmentParticipating parents will receive access to a 12-week online course designed to teach Pivotal Response Treatment (PRT) strategies in Spanish. The course includes 10 instructional lessons and check-ins with a researcher via secure videoconference. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 2 to 5 years, 11 months at the time of consent
- Diagnosis of Autism Spectrum Disorder (ASD), confirmed through medical records and/or parent questionnaire
- Significant language delay, indicated by scores 2 standard deviations (SD) below the average for ages 2 and 3, or 3 SD below the average for ages 4 and 5 on the Vineland-3 Communication subscale or Expressive V-scale
- A Spanish-speaking parent or primary caregiver available to consistently participate in study activities and implement PRT in Spanish
- Stable on any psychotropic medications or biomedical interventions for at least 1 month before baseline, with no anticipated changes during the study
Key exclusion criteria (4 listed)
- Primary language of the child or parent is not Spanish
- Either the child or parent has a severe psychiatric disorder or an unstable medical condition
- Prior exposure to or adequate trial of Pivotal Response Treatment, resulting in the parent achieving fidelity in PRT implementation at baseline
- The child is currently receiving more than 15 hours of one-on-one Applied Behavior Analysis (ABA) therapy per week
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 TreatmentPRT will target functional communication abilities | Behavioural | Spanish PRT Online |
Primary outcome
Change in Parent Fidelity of PRT Implementation from Baseline to Week 12
Time frame: Baseline, Week 12
Based on behavioral coding of parent-child interaction videos in the home
4 secondary outcomes
Change in Child Frequency of Functional Utterances from Baseline to Week 12
Time frame: Baseline, Week 12
Change in Child Frequency of Functional Utterances from Baseline to Week 12
Time frame: Baseline, Week 12
Change in Child Socialization and Communication from Baseline to Week 12
Time frame: Baseline, Week 12
Change in Child Socialization and Communication from Baseline to Week 12
Time frame: Baseline, Week 12
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 22 Jun 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.
Ty Vernon, Ph.D. contact
Grace Gengoux, Ph.D. 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 in people with 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 7 inclusion and 4 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 22 Jun 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 Grace Gengoux, Ph.D. (6507235511, ggengoux@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Parent Fidelity of PRT Implementation from Baseline to Week 12 (time frame: Baseline, Week 12). 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 22 Jun 2026.