Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With Autism

NCT07522190 | Not Yet Recruiting

• 1 other identifier: IRB-84604
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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 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; Autism Spectrum Disorder (ASD)

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 12, Week 24, Week 36, Week 48

Secondary Outcomes (2)

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

  Baseline, Week 12, Week 24, Week 36, Week 48

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

  Baseline, Week 12, Week 24, Week 36, Week 48

Study Arms (3)

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)

Interventions

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.

Early Start Denver Model (ESDM)

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

Developmental Reciprocity Treatment (DRT)

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.

Pivotal Response Treatment (PRT)

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A.) children must be between 2 and 4 years, 11 months of age at enrollment; B.) have a confirmed diagnosis of autism spectrum disorder based on standardized diagnostic assessments and clinical judgment; C.) demonstrate significant language delay as determined by standardized language measures; D.) be able to participate in study assessments and intervention procedures; E.) have at least one English-speaking parent or caregiver available to participate in parent training and research measures; and F.) be receiving stable community-based treatments or medications for at least one month prior to baseline, with no anticipated changes during the study period.

You may not qualify if:

• A.) current or lifetime diagnosis of a severe psychiatric disorder (e.g., bipolar disorder); B.) presence of an active or unstable medical condition (e.g., uncontrolled seizure disorder or significant cardiac disease); C.) child's primary language other than English; D.) prior adequate trial of PRT or ESDM; E.) receipt of more than 15 hours per week of in-home applied behavior analysis services; or F.) inability to complete study assessments or procedures to obtain valid data.

Sponsors & Collaborators

• Stanford University: lead
• John and Marcia Goldman Foundation: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94305-5719, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Communication; Language

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Officials

• Antonio Hardan, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Grace Gengoux, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliya Pattammady, PhD

CONTACT

650-736-1235; juliya@stanford.edu

Robin Libove

CONTACT

650-736-1235; rlibove@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry & Behavioral Sciences

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2037
• Study Completion (Estimated): January 1, 2037
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)