An interventional study of Early Start Denver Model (ESDM) and Pivotal Response Treatment (PRT) in Autism Spectrum Disorder (ASD) and Autism, sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to participants aged 2 Years to 4 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 140 is above the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Autism Spectrum Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioral: Early Start Denver Model (ESDM)
Behavioral: Pivotal Response Treatment (PRT)
Behavioral: Developmental Reciprocity Treatment (DRT)
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.
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.
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
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.
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48
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.
Time frame: 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.
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jan 2037, 120 months later.
Of 354 non-industry interventional studies with no phase under Autistic Disorder, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's planned 120 months is above that.
Counting every sponsor, half of 366 studies reached it within 26 months; a quarter within 13 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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