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

Examining the Effectiveness of the Early Start Denver Model in Community Programs

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

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 12 Months and up
• Sex: All
• Sponsor: University of California, Davis (other)
• Locations: 1 site (Sacramento, California)
• Trial ID: NCT06005285 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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

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 performed: 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.

Eligibility 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 this trial is running

Sacramento, California

• University of California, Davis MIND Institute — Sacramento, California, United States (RECRUITING)

Study contacts

• Principal investigator: Aubyn C Stahmer, PhD — UC Davis
• Study coordinator: Aubyn Stahmer, PhD

Conditions: Autism, early intervention, community effectiveness, early start denver model