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Clinical trial Recruiting at 1 site Interventional Ages 12 Months and up

Evaluating the Early Start Denver Model for young children with autism in community settings

Official title: Examining the Effectiveness of the Early Start Denver Model in Community Programs

Run by University of California, Davis · NCT06005285 · Data updated 2026-11-12

This study is testing if the Early Start Denver Model can improve autism care for young children in community settings.

Quick facts

Study typeInterventional
Ages12 Months and up
SexAll
Enrollment600 (estimated)
SponsorUniversity of California, Davis
Academic / other
Locations1 site (Sacramento, California)
StatusRecruiting
StartedMarch 1, 2024
Main results expectedJanuary 1, 2028
Study endsJune 1, 2028
Registry record updatedDecember 5, 2025
Trial IDNCT06005285 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children aged 1-5 years with a diagnosis of autism spectrum disorder who are receiving services from participating community-based agencies.

Probably not a fit

Patients who are not diagnosed with autism or are older than 5 years may not receive any benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of the Early Start Denver Model (ESDM) in community agencies that serve young autistic children. It aims to assess the feasibility, usability, and acceptability of ESDM, which integrates strategies from applied behavior analysis and developmental science. By collecting data from various stakeholders, including regional managers, supervisors, and technicians, the study seeks to understand how ESDM can improve autism care in diverse settings. The ultimate goal is to enhance the quality of autism interventions available to families across different geographic locations.

Why it matters

Potential benefit: If successful, this study could significantly improve the quality of autism care for young children by validating an effective intervention model in community settings.

How similar studies have gone: Previous studies have shown the effectiveness of the Early Start Denver Model in controlled settings, but this study is novel in its focus on community-based implementation.

Who can join: the full rules

Show full inclusion / exclusion criteria 
The investigators will collect data from leaders, providers and clients in participating autism CBAs. The investigators will collect data from 20 Regional Managers, 100 supervisors, and 200 technicians working with autistic children. Participants will include 300 children ages 1-5 years with a diagnosis of autism spectrum disorder living in the US and being served by participating treatment team.

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:

1. employed as a program supervisor at participating region
2. plans to be employed for at least the next 12 months
3. serves children with autism under age 5
4. has not has previous training in ESDM
5. supervises at least two technicians

Inclusion criteria for technicians is as follows:

1. supervised by a participating supervisor
2. plans to be employed for at least the next 12 months
3. serves children with autism under age 5
4. has not had previous ESDM training

Inclusion criteria for children are as follows:

1. child age 1-5 years
2. has a current autism spectrum disorder (ASD) diagnosis on record or is being served as at-risk for ASD if under age 3
3. family speaks English or Spanish
4. child expected to be in therapy for at least 7 months

Where it's running

  • University of California, Davis MIND Institute
    Sacramento, California, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.