Actively Recruiting

Phase Not Applicable
Age: 12Months +
All Genders
NCT06005285

Examining the Effectiveness of the Early Start Denver Model in Community Programs Serving Young Autism

Led by University of California, Davis · Updated on 2025-12-05

600

Participants Needed

1

Research Sites

221 weeks

Total Duration

On this page

Sponsors

U

University of California, Davis

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Examining the Effectiveness of the Early Start Denver Model in Community Programs Serving Young Autism

Who Can Participate

Age: 12Months +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 1 to 5 years
  • Have a current autism spectrum disorder diagnosis or are at-risk for ASD if under age 3
  • Family speaks English or Spanish
  • Child is expected to be in therapy for at least 7 months
  • Community-based autism agencies serve at least 10 children with autism under age 5 annually and have at least 2 regions that can be randomized
  • Agencies accept Medicaid or equivalent payment for low income families
  • Supervisors employed in participating regions, plan to stay employed for next 12 months, serve children under age 5, have no previous ESDM training, and supervise at least two technicians
  • Technicians supervised by participating supervisors, plan to stay employed for next 12 months, serve children under age 5, and have no previous ESDM training
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of California, Davis MIND Institute

Sacramento, California, United States, 95817

Actively Recruiting

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Research Team

A

Aubyn Stahmer, PhD

CONTACT

S

Sarah Dufek, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Examining the Effectiveness of the Early Start Denver Model in Community Programs Serving Young Autism | DecenTrialz