Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With Autism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early Start Denver Model (ESDM), Pivotal Response Treatment (PRT), Developmental Reciprocity Treatment (DRT).
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder (ASD), Autism. Basic parameters: 2 years — 4 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Controlled Trial of Center-Based Early Start Denver Model (ESDM) vs. Pivotal Response Treatment (PRT) in Children With Autism
Overview
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.
Interventions
- Behavioral 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 develo - Behavioral 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 engagemen - Behavioral 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
Primary outcome measures
- Week 24 Clinical Global Impressions - Improvement (CGI-I) [Time frame: Baseline, Week 12, Week 24, Week 36, Week 48]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford University — Palo Alto
Identifiers
NCT: NCT07522190 · IRB-84604