NCT06005285 · University of California, Davis
Examining the Effectiveness of the Early Start Denver Model in Community Programs Serving Young Autism
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Early Start Denver Model (ESDM)
The Early Start Denver Model focuses on teaching inside children's play and care activities, carried out within a joint activity structure. Adults follow children's leads into activities, embed teaching objectives inside the play, use the play as the reward, and build targeted skills following developmental science and ABA principles.
BEHAVIORAL
Early Intensive Behavioral Intervention (EIBI)
Treatment as usual provided by community-based autism agencies
Primary outcome measures
Assessment of Phase of Preschool Language (APPL)
Time frame: Baseline, 6 months, 12 months
the APPL operationalizes research-based language development stages. Language phases are derived from spoken language or augmentative communication systems and standardized assessments. Language samples will be obtained from transcriptions of child-caregiver interactions recorded at each timepoint and coded by naive observers
Vineland Adaptive Behavior Scales-3rd Edition (VABS-3) Communication Domain
Time frame: Baseline, 6 months, 12 months
Standardized parent interview measuring the use of adaptive communication. The Vineland Adaptive Behavior Scales-3rd Edition communication domain provides a standardized score with a mean of 100 and a standard deviation of 15. Higher scores mean better outcomes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for Autism CBAs include: Serve at least 10 children with autism under age 5 annually and have at least 2 regions that can be randomized. Accept Medicaid or equivalent payment (e.g., funding for low income families through public service systems). Inclusion criteria for supervisors are as follows:
- employed as a program supervisor at participating region
- plans to be employed for at least the next 12 months
- serves children with autism under age 5
- has not has previous training in ESDM
- supervises at least two technicians Inclusion criteria for technicians is as follows:
- supervised by a participating supervisor
- plans to be employed for at least the next 12 months
- serves children with autism under age 5
- has not had previous ESDM training Inclusion criteria for children are as follows:
- child age 1-5 years
- has a current autism spectrum disorder (ASD) diagnosis on record or is being served as at-risk for ASD if under age 3
- family speaks English or Spanish
- child expected to be in therapy for at least 7 months
Where
- Sacramento, California
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 5, 2025 · Source of record for eligibility and locations