Early Start Denver Model for Autism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the Early Start Denver Model (ESDM) to evaluate its effectiveness for young autistic children in various community settings. ESDM is a play-based therapy involving parents and emphasizing positive interactions. The trial will compare ESDM with standard treatments provided by community agencies. It suits children aged 1-5 with an autism diagnosis or those considered at risk, who will participate in therapy for at least 7 months. As an unphased trial, this study provides a unique opportunity to understand how ESDM can be effectively implemented in diverse community settings.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What prior data suggests that the Early Start Denver Model (ESDM) is safe for young autistic children?
Research has shown that the Early Start Denver Model (ESDM) is generally well-received by young autistic children. In past studies, children participating in ESDM demonstrated improvements in communication, daily living skills, and thinking abilities over time. Reports indicate that children in ESDM programs often experience significant developmental benefits without major negative effects.
The ESDM uses several methods, including applied behavior analysis (ABA), which is already common in autism care, suggesting its safety. Additionally, caregiver involvement helps monitor potential issues and allows for adjustments if needed.
Overall, no strong evidence of safety problems with ESDM exists. It appears to be a promising and safe approach for early autism intervention.12345Why are researchers excited about this trial?
Researchers are excited about the Early Start Denver Model (ESDM) for autism because it combines several unique elements into one comprehensive approach. Unlike traditional methods, ESDM integrates naturalistic applied behavior analysis (ABA) with relationship-based, developmental, and play-based techniques, making it more adaptable to a child's everyday activities. This model also emphasizes caregiver involvement by equipping them with coaching strategies to support their child's development at home. The hope is that by focusing on interpersonal exchanges and positive interactions, ESDM can lead to more meaningful, long-term improvements in social and communication skills for children with autism.
What evidence suggests that the Early Start Denver Model (ESDM) is effective for autism?
Research has shown that the Early Start Denver Model (ESDM), which participants in this trial may receive, holds promise for helping young autistic children. Studies have found that ESDM improves overall development, including language and social skills, more effectively than traditional treatments. Specifically, children who received ESDM demonstrated better thinking and learning abilities after two years in the program. The model uses natural interactions and play to engage children, enhancing their learning experiences. Involving caregivers is also a key part of ESDM, further supporting the child's progress. This evidence suggests that ESDM is an effective early intervention approach for autism.12678
Who Is on the Research Team?
Aubyn C Stahmer, PhD
Principal Investigator
UC Davis
Are You a Good Fit for This Trial?
This trial is for young children aged 1-5 with autism or at risk for ASD, who haven't had ESDM training and will be in therapy for at least 7 months. Agencies must serve at least 10 such children annually, accept Medicaid, and have staff willing to participate for over a year.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Early Start Denver Model (ESDM) intervention, focusing on improving social communication and language outcomes in young autistic children.
Follow-up
Participants are monitored for effectiveness and caregiver engagement after the treatment phase.
What Are the Treatments Tested in This Trial?
Interventions
- Early Intensive Behavioral Intervention (EIBI)
- Early Start Denver Model (ESDM)
Early Intensive Behavioral Intervention (EIBI) is already approved in United States, European Union for the following indications:
- Autism Spectrum Disorder (ASD) in young children
- Autism Spectrum Disorder (ASD) in young children
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator