Autism Spectrum Disorder (ASD)NCT07522190
Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With Autism
A study testing Early Start Denver Model (ESDM), Pivotal Response Treatment (PRT) and Developmental Reciprocity Treatment (DRT) in people with Autism Spectrum Disorder (ASD) and Autism, run by Stanford University at 1 site in United States.
Trial summary
The goal of this study is to compare two well-established early autism interventions, Early Start Denver Model (ESDM) and Pivotal Response Treatment (PRT), to better understand which approach is most effective for improving communication skills in young children with autism and which children may benefit most from… Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD), Autism
- What is being tested?
- Early Start Denver Model (ESDM), Pivotal Response Treatment (PRT) and Developmental Reciprocity Treatment (DRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jan 2037
- 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
- Children must be between 2 and 4 years, 11 months of age at enrollment
- Confirmed diagnosis of autism spectrum disorder based on standardized diagnostic assessments and clinical judgment
- Demonstrated significant language delay as determined by standardized language measures
- Ability to participate in study assessments and intervention procedures
- At least one English-speaking parent or caregiver available to participate in parent training and research measures
- Receiving stable community-based treatments or medications for at least one month prior to baseline, with no anticipated changes during the study period
Who cannot join
- Current or lifetime diagnosis of a severe psychiatric disorder (e.g., bipolar disorder)
- Presence of an active or unstable medical condition (e.g., uncontrolled seizure disorder or significant cardiac disease)
- Child's primary language is not English
- Prior adequate trial of PRT or ESDM
- Receipt of more than 15 hours per week of in-home applied behavior analysis services
- Inability to complete study assessments or procedures to obtain valid data
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
Stanford University
Palo Alto, California, 94305-5719
Juliya Pattammady, PhD, 650-736-1235, PALprogram@stanford.edu
Robin Libove, 650-736-1235, rlibove@stanford.edu
About this study
Official title: Randomized Controlled Trial of Center-Based Early Start Denver Model (ESDM) vs. Pivotal Response Treatment (PRT) in Children With Autism
The goal of this study is to compare two well-established early autism interventions, Early Start Denver Model (ESDM) and Pivotal Response Treatment (PRT), to better understand which approach is most effective for improving communication skills in young children with autism and which children may benefit most from each treatment. Additionally, after completing either the ESDM or PRT, some participants who meet specific clinical criteria may be offered home-based Developmental Reciprocity Treatment (DRT). The study will include boys and girls 2 to 4 years 11 months old diagnosed with ASD. The main questions this study aims to answer are whether center-based ESDM and center-based PRT improve communication skills in young children with autism, and whether certain children respond better to one treatment approach than the other. Participants will be randomly assigned to either ESDM or PRT for 24 weeks in a center-based program, attend treatment session 4 days per week (~3 hours/day), complete developmental and autism assessments at baseline, 12 weeks, and 24 weeks, have a parent participate in weekly parent training sessions, and complete follow-up assessments at weeks 36 and 48.
- Conditions
- Autism Spectrum Disorder (ASD), Autism
- Being tested
- Early Start Denver Model (ESDM), Pivotal Response Treatment (PRT), Developmental Reciprocity Treatment (DRT)
- Keywords
- Autism, Autism Spectrum Disorder, Early Start Denver Model (ESDM), Pivotal Response Treatment (PRT), Early Intervention, Naturalistic Developmental Behavioral Intervention (NDBI), Communication, Early Development, Parents, Language
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Communication, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Start Denver Model (ESDM)Behavioural
ESDM is a comprehensive, play-based early intervention that integrates applied behavior analysis with developmental and social-pragmatic approaches. ESDM uses a structured curriculum to systematically target communication, social engagement, imitation, cognition, and play skills. The intervention is delivered within joint activity routines that emphasize the interactions between the child and adult. Goals are individualized and embedded into naturalistic play and daily routines to support developmental progress. Children will participate in center-based treatment 4 days per week for 3 hours per day for 24 weeks. The parent will be encouraged to practice the intervention at home and submit one 10-minute parent-child interaction video regularly during the 24 weeks.
Pivotal Response Treatment (PRT)Behavioural
PRT s a naturalistic, play-based intervention based on principles of applied behavior analysis. Instead of working on developing skills in isolation, PRT focuses on "pivotal" areas of development like motivation, responsivity to cues, and self-initiation. The idea is that working on these areas will lead to broad improvements across communication and behavior. Through the intervention, therapists and parents integrate various strategies into child-led play to increase communication and engagement. Children will participate in center-based treatment 4 days per week for 3 hours per day for 24 weeks. The parent will be encouraged to practice the intervention at home and submit one 10-minute parent-child interaction video regularly during the 24 weeks.
Developmental Reciprocity Treatment (DRT)Behavioural
DRT is a relationship-based, developmental intervention that targets the foundations of social reciprocity such as shared attention, emotional engagement, and back-and-forth interaction. DRT emphasizes building the child's capacity for mutual engagement with parents or therapists through interactions that follow the child's lead. This will be a 24-week home-based intervention for with weekly parent training
| Study group | Role | What they receive |
|---|---|---|
| Early Start Denver Model (ESDM) | Experimental | Not described Receives: Behavioral: Early Start Denver Model (ESDM) |
| Pivotal Response Treatment (PRT) | Experimental | Not described Receives: Behavioral: Pivotal Response Treatment (PRT) |
| Developmental Reciprocity Treatment (DRT) | Experimental | Not described Receives: Behavioral: Developmental Reciprocity Treatment (DRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Week 24 Clinical Global Impressions - Improvement (CGI-I)
A clinician rating that measures how much a child's overall symptoms and functioning have improved or worsened compared to the start of treatment. The CGI ratings will be assessed by a psychologist blind to group assignment and treatment phase, and will specifically focus on social and communication skills.
Measured: Baseline, Week 12, Week 24, Week 36, Week 48
Secondary outcomes (2)
Change from Baseline on Functional utterances during Structured Laboratory Observation (SLO)
The number of meaningful spoken words or phrases a child uses to communicate during a structured play interaction with the parent.
Measured: Baseline, Week 12, Week 24, Week 36, Week 48
Change from Baseline on Early Start Denver Model Curriculum Checklist (ESDM-CC)
A clinician-rated assessment used to measure a child's developmental skills across multiple areas, including communication, social interaction, play, and cognitive abilities. Scores reflect skills gained across developmental domains over time.
Measured: Baseline, Week 12, Week 24, Week 36, Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2037 (estimated)
- Study completionJan 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- John and Marcia Goldman Foundation
- Responsible party
- Principal investigator, Antonio Hardan, Stanford University
- Investigators
- Antonio Hardan, MD, Principal investigator, Stanford UniversityGrace Gengoux, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522190
- Sponsor's protocol ID
- IRB-84604
- Status last verified
- Nov 2026
- First submitted
- 3 Apr 2026
- Last updated
- 5 Nov 2026
- Results posted
- 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 Early Start Denver Model (ESDM) vs. Pivotal Response Treatment (PRT) in Children With Autism
- ClinicalTrials.gov ID
- NCT07522190
- Acronym / sponsor ID
- IRB-84604
- Conditions
- Autism Spectrum Disorder (ASD), Autism
- Keywords
- Autism, Autism Spectrum Disorder, Early Start Denver Model (ESDM), Pivotal Response Treatment (PRT), Early Intervention, Naturalistic Developmental Behavioral Intervention (NDBI), Communication, Early Development
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- John and Marcia Goldman Foundation
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2037 (estimated)
- Study completion
- Jan 2037 (estimated)
- First posted
- 13 Apr 2026 (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 study is to compare two well-established early autism interventions, Early Start Denver Model (ESDM) and Pivotal Response Treatment (PRT), to better understand which approach is most effective for improving communication skills in young children with autism and which children may benefit most from each treatment. Additionally, after completing either the ESDM or PRT, some participants who meet specific clinical criteria may be offered home-based Developmental Reciprocity Treatment (DRT). The study will include boys and girls 2 to 4 years 11 months old diagnosed with ASD. The main questions this study aims to answer are whether center-based ESDM and center-based PRT improve communication skills in young children with autism, and whether certain children respond better to one treatment approach than the other. Participants will be randomly assigned to either ESDM or PRT for 24 weeks in a center-based program, attend treatment session 4 days per week (~3 hours/day), complete developmental and autism assessments at baseline, 12 weeks, and 24 weeks, have a parent participate in weekly parent training sessions, and complete follow-up assessments at weeks 36 and 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Start Denver Model (ESDM) | Experimental | Behavioral: Early Start Denver Model (ESDM) |
| Pivotal Response Treatment (PRT) | Experimental | Behavioral: Pivotal Response Treatment (PRT) |
| Developmental Reciprocity Treatment (DRT) | Experimental | Behavioral: Developmental Reciprocity Treatment (DRT) |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children must be between 2 and 4 years, 11 months of age at enrollment
- Confirmed diagnosis of autism spectrum disorder based on standardized diagnostic assessments and clinical judgment
- Demonstrated significant language delay as determined by standardized language measures
- Ability to participate in study assessments and intervention procedures
- At least one English-speaking parent or caregiver available to participate in parent training and research measures
Key exclusion criteria (6 listed)
- Current or lifetime diagnosis of a severe psychiatric disorder (e.g., bipolar disorder)
- Presence of an active or unstable medical condition (e.g., uncontrolled seizure disorder or significant cardiac disease)
- Child's primary language is not English
- Prior adequate trial of PRT or ESDM
- Receipt of more than 15 hours per week of in-home applied behavior analysis services
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 |
|---|---|---|
| Early Start Denver Model (ESDM)ESDM is a comprehensive, play-based early intervention that integrates applied behavior analysis with developmental and social-pragmatic approaches. ESDM uses a structured curriculum to systematically target communication, social engagement, imitation, cognition, and play skills. The intervention is delivered within joint activity routines that emphasize the interactions between the child and adult. Goals are individualized and embedded into naturalistic play and daily routines to support developmental progress. Children will participate in center-based treatment 4 days per week for 3 hours per day for 24 weeks. The parent will be encouraged to practice the intervention at home and submit one 10-minute parent-child interaction video regularly during the 24 weeks. | Behavioural | Early Start Denver Model (ESDM) |
| Pivotal Response Treatment (PRT)PRT s a naturalistic, play-based intervention based on principles of applied behavior analysis. Instead of working on developing skills in isolation, PRT focuses on "pivotal" areas of development like motivation, responsivity to cues, and self-initiation. The idea is that working on these areas will lead to broad improvements across communication and behavior. Through the intervention, therapists and parents integrate various strategies into child-led play to increase communication and engagement. Children will participate in center-based treatment 4 days per week for 3 hours per day for 24 weeks. The parent will be encouraged to practice the intervention at home and submit one 10-minute parent-child interaction video regularly during the 24 weeks. | Behavioural | Pivotal Response Treatment (PRT) |
| Developmental Reciprocity Treatment (DRT)DRT is a relationship-based, developmental intervention that targets the foundations of social reciprocity such as shared attention, emotional engagement, and back-and-forth interaction. DRT emphasizes building the child's capacity for mutual engagement with parents or therapists through interactions that follow the child's lead. This will be a 24-week home-based intervention for with weekly parent training | Behavioural | Developmental Reciprocity Treatment (DRT) |
Primary outcome
Week 24 Clinical Global Impressions - Improvement (CGI-I)
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48
A clinician rating that measures how much a child's overall symptoms and functioning have improved or worsened compared to the start of treatment. The CGI ratings will be assessed by a psychologist blind to group assignment and treatment phase, and will specifically focus on social and communication skills.
2 secondary outcomes
Change from Baseline on Functional utterances during Structured Laboratory Observation (SLO)
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48
Change from Baseline on Early Start Denver Model Curriculum Checklist (ESDM-CC)
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48
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 Hardan, MD principal investigator
Stanford University
Grace Gengoux, PhD 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 Early Start Denver Model (ESDM), Pivotal Response Treatment (PRT) and Developmental Reciprocity Treatment (DRT) 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 6 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: opening soon, 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 Juliya Pattammady, PhD (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?
Week 24 Clinical Global Impressions - Improvement (CGI-I) (time frame: Baseline, Week 12, Week 24, Week 36, Week 48). 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.