Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With Autism
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-4
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Early Start Denver Model (ESDM)
BehavioralESDM 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)
BehavioralPRT 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)
BehavioralDRT 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
Treatment groups
140 Participants
are divided into 3 treatment groupsGroup A: Early Start Denver Model (ESDM)Experimental treatment 1 intervention
Group B: Pivotal Response Treatment (PRT)Experimental treatment 1 intervention
Group C: Developmental Reciprocity Treatment (DRT)Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline, Week 12, Week 24, Week 36, Week 48Secondary outcomes
1
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 482
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 48Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
John and Marcia Goldman Foundation
Collaborator
Source ClinicalTrials.gov
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