Autism Spectrum Disorder (ASD)PRT-PNCT02037022
Pivotal Response Treatment Package for Young Children With Autism
A study testing Pivotal Response Treatment Package (PRT-P) in people with Autism Spectrum Disorder (ASD) and Autism, run by Stanford University at 1 site in United States.
Trial summary
This is a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD), Autism
- What is being tested?
- Pivotal Response Treatment Package (PRT-P)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2013to 28 Jul 2017
- 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 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 (ADOS-2), and expert clinical opinion
- Males and females in good medical health 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: Standard score at least 1 Standard Deviation below average for expressive language ability
- Stable treatment, speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation
- No more than 60 minutes of individual 1:1 speech therapy per week
Show all 9Show fewer
- Availability of at least one parent who can consistently participate in parent training and research measures
- Parents intend on continuing Pivotal Response Treatment Package (PRT-P) for a minimum of 12 weeks
- Parents must be 18 years of age or older
Who cannot join
- Current or lifetime diagnosis of severe psychiatric disorder, such as bipolar disorder
- Receiving in-home Applied Behavior Analysis (ABA) of 10 hours or more
- A genetic abnormality, such as Fragile X
- Presence of active medical problem, such as unstable seizure disorder or heart disease
- Previous adequate PRT trial
- Participants living more than 50 miles from Stanford University
Show all 9Show fewer
- At least one room of the house must be available to be dedicated to treatment during session times
- There must be no serious health and safety risks present in the home environment
- The research team has the right to refuse to perform sessions in-home even if the criteria above are met
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305-5719
About this study
This is a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism.
Read the detailed description
Researchers at the Stanford University School of Medicine are seeking participants for a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. Researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement PRT with in-home, therapist-implemented treatment. To determine the effectiveness of a PRT-P, it will be compared to a delayed treatment group (DTG) by conducting a randomized controlled 24-week trial. This research will allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families. We hope that investigating interventions that aim to improve core deficits will aid clinicians in providing better care for children with autism.
- Conditions
- Autism Spectrum Disorder (ASD), Autism
- Being tested
- Pivotal Response Treatment Package (PRT-P)
- Keywords
- Autism Spectrum Disorder (ASD), Autism
- 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 Package (PRT-P)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Pivotal Response Treatment Package | Experimental | Pivotal Response Treatment Package (PRT-P) Receives: Behavioral: Pivotal Response Treatment Package (PRT-P) |
| Delayed Treatment Group | No intervention | Delayed Treatment Group (DTG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks
Measured: 6, 12 and 24 weeks
Secondary outcomes (10)
Change from Baseline on the Preschool Language Scale, 5th Edition (PLS-5) at 12, and 24 weeks
Measured: 12 and 24 weeks
Change from Baseline on the Sensory Profile Questionnaire at 6, 12, and 24 weeks
Measured: 6, 12 and 24 weeks
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
Measured: 6, 12 and 24 weeks
Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks
Measured: 6, 12 and 24 weeks
Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks
Measured: 6, 12 and 24 weeks
Change from Baseline on the Behavior Rating Inventory of Executive Function, Preschool (BRIEF-P) at 6, 12, and 24 weeks
Measured: 6, 12 and 24 weeks
Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks
Measured: 6, 12, and 24 weeks
Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks
Measured: 6, 12, and 24 weeks
Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks
Measured: 6, 12, and 24 weeks
Change from Baseline on the Social attention and word-learning eye tracking task at 12, and 24 weeks
Measured: 12, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study start4 Dec 2013
- Primary completion28 Jul 2017
- Study completion28 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum Disorder (ASD)Studies 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
- None (open label)
- Enrolment
- 48 participants (actual)
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, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037022
- Sponsor's protocol ID
- IRB-28314
- Other IDs
- R21DC013689
- Acronym
- PRT-P
- Status last verified
- Feb 2020
- First submitted
- 13 Jan 2014
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Gengoux GW, Abrams DA, Schuck R, Millan ME, Libove R, Ardel CM, Phillips JM, Fox M, Frazier TW, Hardan AY. A Pivotal Response Treatment Package for Children With Autism Spectrum Disorder: An RCT. Pediatrics. 2019 Sep;144(3):e20190178. doi: 10.1542/peds.2019-0178. Epub 2019 Aug 6.
PubMed 31387868Gengoux GW, Schapp S, Burton S, Ardel CM, Libove RA, Baldi G, Berquist KL, Phillips JM, Hardan AY. Effects of a parent-implemented Developmental Reciprocity Treatment Program for children with autism spectrum disorder. Autism. 2019 Apr;23(3):713-725. doi: 10.1177/1362361318775538. Epub 2018 May 18.
PubMed 29775078
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Response Treatment Package for Young Children With Autism
- ClinicalTrials.gov ID
- NCT02037022
- Acronym / sponsor ID
- PRT-P / IRB-28314
- Conditions
- Autism Spectrum Disorder (ASD), Autism
- Keywords
- Autism Spectrum Disorder (ASD), Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 4 Dec 2013 (actual)
- Primary completion
- 28 Jul 2017 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 15 Jan 2014 (estimated)
- 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.
This is a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism.
Detailed description
Researchers at the Stanford University School of Medicine are seeking participants for a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. Researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement PRT with in-home, therapist-implemented treatment. To determine the effectiveness of a PRT-P, it will be compared to a delayed treatment group (DTG) by conducting a randomized controlled 24-week trial. This research will allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families. We hope that investigating interventions that aim to improve core deficits will aid clinicians in providing better care for children with autism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pivotal Response Treatment Package | Experimental | Behavioral: Pivotal Response Treatment Package (PRT-P)Pivotal Response Treatment Package (PRT-P) |
| Delayed Treatment Group | No intervention | –Delayed Treatment Group (DTG) |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview- Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS-2), and expert clinical opinion
- Males and females in good medical health 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: Standard score at least 1 Standard Deviation below average for expressive language ability
- Stable treatment, speech therapy, school placement, 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 (9 listed)
- Current or lifetime diagnosis of severe psychiatric disorder, such as bipolar disorder
- Receiving in-home Applied Behavior Analysis (ABA) of 10 hours or more
- A genetic abnormality, such as Fragile X
- Presence of active medical problem, such as unstable seizure disorder or heart disease
- Previous adequate PRT trial
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 Package (PRT-P) | Behavioural | Pivotal Response Treatment Package |
Primary outcome
Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks
Time frame: 6, 12 and 24 weeks
10 secondary outcomes
Change from Baseline on the Preschool Language Scale, 5th Edition (PLS-5) at 12, and 24 weeks
Time frame: 12 and 24 weeks
Change from Baseline on the Sensory Profile Questionnaire at 6, 12, and 24 weeks
Time frame: 6, 12 and 24 weeks
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
Time frame: 6, 12 and 24 weeks
Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks
Time frame: 6, 12 and 24 weeks
Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks
Time frame: 6, 12 and 24 weeks
Change from Baseline on the Behavior Rating Inventory of Executive Function, Preschool (BRIEF-P) at 6, 12, and 24 weeks
Time frame: 6, 12 and 24 weeks
Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks
Time frame: 6, 12, and 24 weeks
Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks
Time frame: 6, 12, and 24 weeks
Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks
Time frame: 6, 12, and 24 weeks
Change from Baseline on the Social attention and word-learning eye tracking task at 12, and 24 weeks
Time frame: 12, and 24 weeks
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 25 Feb 2020.
- Results publication: PubMed 31387868Gengoux GW, Abrams DA, Schuck R, Millan ME, Libove R, Ardel CM, Phillips JM, Fox M, Frazier TW, Hardan AY. A Pivotal Response Treatment Package for Children With Autism Spectrum Disorder: An RCT. Pediatrics. 2019 Sep;144(3):e20190178. doi: 10.1542/peds.2019-0178. Epub 2019 Aug 6.
- Derived from this study: PubMed 29775078Gengoux GW, Schapp S, Burton S, Ardel CM, Libove RA, Baldi G, Berquist KL, Phillips JM, Hardan AY. Effects of a parent-implemented Developmental Reciprocity Treatment Program for children with autism spectrum disorder. Autism. 2019 Apr;23(3):713-725. doi: 10.1177/1362361318775538. Epub 2018 May 18.
Related trials for Autism Spectrum Disorder (ASD)
Recruiting
Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
Autism, Autism Spectrum Disorder
Not yet recruiting
Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With Autism
Autism Spectrum Disorder (ASD), Autism
Active, not recruiting
An Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism
Autism Spectrum Disorder (ASD)
Recruiting
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
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 Hardan, M.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 Package (PRT-P) in people with Autism Spectrum Disorder (ASD) 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 9 inclusion and 9 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 25 Feb 2020. 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?
Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks (time frame: 6, 12 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02037022, which also lists 2 linked publications.
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 25 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.