Early Start Denver Model for Autism

Overseen By Sarah Dufek, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Non-English/Spanish, Over age 5, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

600 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 6 7 8}

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

My child, aged 1-5, has autism and lives in the US under care.

I am a program supervisor for children under 5 with autism, plan to work for the next year, haven't had ESDM training, and supervise at least two technicians.

Investigators will collect data from leaders, providers, and clients in participating autism CBAs

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Early Start Denver Model (ESDM) intervention, focusing on improving social communication and language outcomes in young autistic children.

12 months

Monthly caregiver coaching sessions

Follow-up

Participants are monitored for effectiveness and caregiver engagement after the treatment phase.

6 months

Quarterly assessments

What Are the Treatments Tested in This Trial?

Interventions

• Early Intensive Behavioral Intervention (EIBI)
• Early Start Denver Model (ESDM)

Trial Overview

The study examines the Early Start Denver Model (ESDM) used by community agencies serving autistic children. It aims to assess how practical and effective ESDM is compared to Early Intensive Behavioral Intervention (EIBI) in real-world settings.

How Is the Trial Designed?

Group I: Early Start Denver Model (ESDM) Experimental Treatment 1 Intervention

Early Start Denver Model (ESDM) is a comprehensive model that integrates principles of applied behavior analysis (ABA), relationship-based, developmental, and play-based orientations into an individualized and yet manualized treatment. Core features include the use of naturalistic ABA strategies, sensitivity to typical developmental sequence, caregiver involvement, a focus on interpersonal exchange and positive affect within everyday activities. Providers in the ESDM condition will receive training in caregiver coaching strategies and will be asked to conduct caregiver coaching in the strategies at least monthly.

Group II: Treatment as Usual (TAU) Active Control 1 Intervention

Treatment as usual will vary based on the agency. However, a majority of CBAs use Discrete trial teaching (DTT) based on the Lovaas model.19 DTT involves 10 components described in numerous research publications: capturing child physical and visual attention, adult presentation of the stimuli and instruction (antecedent), child behavior, adult reinforcement, correction procedures, 3-5 second interstimulus interval between trials, behavior-specific praise, and data recording. Most CBAs include caregivers in some way as caregiver involvement is required by most funders. Often, caregivers observe treatment sessions or learn the teaching approach being used with their child. Providers often provide consultation on addressing behavioral concerns.

Early Intensive Behavioral Intervention (EIBI) is already approved in United States, European Union for the following indications:

Approved in United States as Early Start Denver Model for:

• Autism Spectrum Disorder (ASD) in young children

Approved in European Union as Early Start Denver Model for:

• Autism Spectrum Disorder (ASD) in young children

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The two-tiered Parent Early Start Denver Model (P-ESDM) intervention showed that all participating parents improved their use of ESDM strategies after group coaching, indicating the effectiveness of parent-led interventions for young autistic children.

Children exhibited positive changes in engagement, imitation, and communication skills, with significant relationships found between how well parents implemented ESDM strategies and the children's developmental outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a Two-Tiered Parent Coaching Intervention for Young Autistic Children Using the Early Start Denver Model. van Noorden, LE., Sigafoos, J., Waddington, HL.[2022]

A prospective observational study involving 19 toddlers with Autism Spectrum Disorder (ASD) showed significant improvements in cognitive skills after 10 months of Early Start Denver Model (ESDM) intervention, particularly in receptive language development, which improved by an average of 19.6 points.

The study suggests that ESDM, delivered for 12 hours per week by a multidisciplinary team, can lead to positive outcomes in cognitive and adaptive behavior skills in toddlers with ASD, indicating a potential need for longer therapy duration to maximize benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using ESDM 12 hours per week in children with autism spectrum disorder: feasibility and results of an observational study. Geoffray, MM., Denis, A., Mengarelli, F., et al.[2019]

The Early Start Denver Model (ESDM) intervention, applied to 27 young children with autism spectrum disorder (ASD) in Japan, showed significant improvements in language and social development after an average of 8 months of treatment.

Participants also exhibited reduced severity of maladaptive behaviors and impairments in social interaction and communication, indicating that ESDM could be a standard treatment option for children with ASD in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Early Start Denver Model Intervention in Young Children with Autism Spectrum Disorder Within Japan: A Preliminary Study. Tateno, Y., Kumagai, K., Monden, R., et al.[2022]

The Early Start Denver Model (ESDM) was found to be more effective than conventional interventions in improving aberrant behaviors in children with autism spectrum disorder (ASD), as shown by significant reductions in scores on the Aberrant Behavior Checklist (ABC) and Childhood Autism Rating Scale (CARS) after 3 months of treatment.

Both intervention methods improved social withdrawal and hyperactivity, but the ESDM group showed greater improvements in mood swings, social withdrawal, and hyperactivity, along with overall better disease improvement ratings compared to the conventional group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preliminary application of Early Start Denver Model in children with autism spectrum disorder]. Li, HH., Li, CL., Gao, D., et al.[2020]

The Early Start Denver Model (ESDM) is an evidence-based intervention for young children with autism spectrum disorder, emphasizing its effectiveness in early treatment.

There is ongoing debate about whether ESDM qualifies as a form of applied behavior analysis (ABA), highlighting the need for clarity in its classification and implications for practice in the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can the Early Start Denver Model Be Considered ABA Practice? Vivanti, G., Stahmer, AC.[2021]

A study involving 21 toddlers at risk for autism spectrum disorders showed that a low-intensity, ESDM-inspired intervention delivered 3 hours per week over 15 months led to significant improvements in language and cognitive skills.

Earlier diagnosis was linked to greater improvements in autism symptoms, highlighting the effectiveness of early intervention and the importance of involving parents and teachers in the treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early diagnosis and Early Start Denver Model intervention in autism spectrum disorders delivered in an Italian Public Health System service. Devescovi, R., Monasta, L., Mancini, A., et al.[2020]

The Early Start Denver Model (ESDM) is an effective therapy for toddlers with autism spectrum disorder, showing improvements in cognition, language, and adaptive behavior based on a systematic review of eight studies.

The ESDM can be successfully implemented in community group settings and at home by parents, indicating its feasibility and potential for widespread use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for the Implementation of the Early Start Denver Model for Young Children With Autism Spectrum Disorder. Ryberg, KH.[2019]

Citations

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Early Start Denver Model effectiveness in young autistic ...

To assess the effectiveness of ESDM compared with treatment as usual (TAU) on overall development in young children with autism spectrum disorder (ASD).

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Examining the Effectiveness of the Early Start Denver ...

This study tests the effectiveness of the Early Start Denver Model (ESDM) in community agencies that serve young autistic children.

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Clinical outcomes of an early intervention program for ...

Start Denver Model (ESDM), can positively affect key outcomes for children with Autism Spectrum Disorder (ASD). However, programs involving ...

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goldenstepsaba.com

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ESDM Research and Outcomes in Autism

The parent-implemented Early Start Denver Model (P-ESDM) has shown positive child-parent-related outcomes in research published between 2012 and ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8464931/

Feasibility and Outcomes of the Early Start Denver Model ...

The authors find moderate and significant improvement for ESDM-treated children compared to control groups, especially in cognition and language ...

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Early Start Denver Model

Data were collected at baseline and after one year of the ESDM intervention. Results showed improvements in communication skills, adaptive behavior, and ASD ...