Early Start Denver Model vs Pivotal Response Treatment for Autism

JP
Overseen ByJuliya Pattammady, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two autism treatments, the Early Start Denver Model (ESDM) and Pivotal Response Treatment (PRT), to determine which most effectively improves communication skills in young children with autism. After completing one of these programs, some children may also try a home-based therapy called Developmental Reciprocity Treatment (DRT). The trial targets children aged 2 to 4 years and 11 months with autism and significant language delays, requiring a parent to participate in training sessions. Participants will attend one of the therapies four days a week for 24 weeks and undergo regular assessments throughout the study. The goal is to identify which treatment works better for different children. As an unphased trial, this study provides families with a unique opportunity to explore innovative therapies that could significantly enhance their child's communication skills.

Will I have to stop taking my current medications?

The trial requires that participants have been on stable medications for at least one month before starting and do not change them during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that both the Early Start Denver Model (ESDM) and Pivotal Response Treatment (PRT) are safe and beneficial for young children with autism. Research indicates that ESDM, a play-based therapy, uses familiar activities to enhance communication and social skills in autistic children. Evidence shows it is generally well-tolerated, with no major safety concerns reported.

Similarly, PRT improves social communication through play and is known for its safety and adaptability to each child's needs. This approach is typically well-tolerated, with studies highlighting its effectiveness without significant negative effects.

For the Developmental Reciprocity Treatment (DRT), research suggests it is a promising new approach. While detailed safety data remains limited, initial findings show it effectively supports social development. Most parents in DRT-based studies have met training goals, indicating a positive safety and effectiveness profile.

Overall, these interventions are considered safe and well-tolerated for children with autism.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for autism because they offer innovative approaches to improving social and communication skills. The Early Start Denver Model (ESDM) is unique because it integrates play-based activities with developmental and behavioral strategies, encouraging learning in a natural setting. Pivotal Response Treatment (PRT) focuses on motivation and self-management, using a child’s interests to promote learning, which is different from more traditional, structured therapies. Developmental Reciprocity Treatment (DRT) emphasizes building emotional connections and reciprocal interactions, aiming to enhance social engagement. These methods stand out from standard options by fostering skills through everyday interactions and play, potentially leading to more natural and sustained improvements.

What evidence suggests that this trial's treatments could be effective for improving communication skills in young children with autism?

Research has shown that the Early Start Denver Model (ESDM), one of the treatments in this trial, helps young children with autism improve their thinking skills, language, and social interactions. Studies have found that children receiving ESDM develop better thinking and language skills compared to other treatments. Similarly, Pivotal Response Treatment (PRT), another treatment option in this trial, improves social communication in children with autism. Data indicates that many children receiving PRT initiate conversations more often and communicate more effectively. Both ESDM and PRT have strong evidence supporting their effectiveness, making them promising options for enhancing communication skills in children with autism.12367

Who Is on the Research Team?

AH

Antonio Hardan, MD

Principal Investigator

Stanford University

GG

Grace Gengoux, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for children aged 2 to just under 5 years old who have been diagnosed with autism and have significant language delays. They must be able to participate in the study, not currently receive intensive in-home therapy, and have at least one English-speaking parent or caregiver available.

Inclusion Criteria

I have been diagnosed with autism spectrum disorder.
My child is between 2 and 4 years, 11 months old.
I have been on the same treatment or medication for at least one month.
See 3 more

Exclusion Criteria

Current or lifetime diagnosis of a severe psychiatric disorder (e.g., bipolar disorder)
I receive more than 15 hours a week of in-home behavior therapy.
Child's primary language is not English
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either ESDM or PRT for 24 weeks in a center-based program, attending treatment sessions 4 days per week (~3 hours/day), with developmental and autism assessments at baseline, 12 weeks, and 24 weeks, and weekly parent training sessions.

24 weeks
4 visits per week (in-person)

Follow-up

Participants complete follow-up assessments to monitor communication skills and developmental progress.

24 weeks
Assessments at weeks 36 and 48

Optional Extension

Participants who meet specific clinical criteria may be offered home-based Developmental Reciprocity Treatment (DRT).

What Are the Treatments Tested in This Trial?

Interventions

  • Developmental Reciprocity Treatment (DRT)
  • Early Start Denver Model (ESDM)
  • Pivotal Response Treatment (PRT)

Trial Overview

The study compares two center-based therapies—Early Start Denver Model (ESDM) and Pivotal Response Treatment (PRT)—to see which helps young children with autism improve communication skills. Children are randomly assigned to either ESDM or PRT for about six months.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Pivotal Response Treatment (PRT)Experimental Treatment1 Intervention
Group II: Early Start Denver Model (ESDM)Experimental Treatment1 Intervention
Group III: Developmental Reciprocity Treatment (DRT)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

John and Marcia Goldman Foundation

Collaborator

Trials
1
Recruited
20+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40488923/

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