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

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is the Early Start Denver Model (ESDM) safe for humans?

The Early Start Denver Model (ESDM) is generally considered safe for young children with autism spectrum disorder, as it is a developmental and behavioral intervention that has been used in various studies without reported safety concerns. ^{1 2 3 4 5}

How is the Early Start Denver Model treatment different from other autism treatments?

The Early Start Denver Model (ESDM) is unique because it is a naturalistic developmental behavioral intervention that focuses on interpersonal engagement through synchrony, rhythms, and reciprocity to enhance cognitive, social-emotional, and language development in young children with autism. Unlike some other treatments, ESDM can be implemented by parents at home, making it more accessible and integrated into daily life. ^{1 2 3 6 7}

What is the purpose of this trial?

This study tests the effectiveness of the Early Start Denver Model (ESDM) in community agencies that serve young autistic children. The feasibility, usability and acceptability of the model will be explored. Understanding effectiveness of new evidence-based models will increase the quality of autism care available to more diverse children and families in more geographic locations.

Research Team

Aubyn C Stahmer, PhD

Principal Investigator

UC Davis

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Can the Early Start Denver Model Be Considered ABA Practice? [2021]

2. New Zealand 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. [2020]

3. China pubmed.ncbi.nlm.nih.gov

[Preliminary application of Early Start Denver Model in children with autism spectrum disorder]. [2020]

4. Croatia pubmed.ncbi.nlm.nih.gov

Using ESDM 12 hours per week in children with autism spectrum disorder: feasibility and results of an observational study. [2019]

5. Korea (South) 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. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluating a Two-Tiered Parent Coaching Intervention for Young Autistic Children Using the Early Start Denver Model. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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