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NCT Number: NCT07522190

Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment 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.

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Key information

Conditions

Autism Spectrum Disorder (ASD) Autism Autism Spectrum Disorder Autistic Disorder Behavior Child Development Disorders, Pervasive Communication Language Mental Disorders Neurodevelopmental Disorders

Age range

2 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Start Denver Model (ESDM)

Behavioral

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)

Behavioral

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)

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. Change from Baseline on Functional utterances during Structured Laboratory Observation (SLO)

    Time frame: Baseline, Week 12, Week 24, Week 36, Week 48

    The number of meaningful spoken words or phrases a child uses to communicate during a structured play interaction with the parent.

  2. Change from Baseline on Early Start Denver Model Curriculum Checklist (ESDM-CC)

    Time frame: Baseline, Week 12, Week 24, Week 36, Week 48

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Juliya Pattammady, PhD

CONTACT

[email protected]

650-736-1235

Robin Libove

CONTACT

[email protected]

650-736-1235

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • John and Marcia Goldman Foundation

Registry information

Official study title

Randomized Controlled Trial of Center-Based Early Start Denver Model (ESDM) vs. Pivotal Response Treatment (PRT) in Children With Autism

Important dates

Study start
2027
Primary completion
2037
Study completion
2037
First posted
Apr 13, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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