Recruiting

Early Start Denver Model

Sponsor:

UCLA

Code:

NCT06005285

Conditions

Autism

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

Early Start Denver Model (ESDM)

Early Intensive Behavioral Intervention (EIBI)

Study Details

Brief summary:

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

Autism

Study ID

NCT06005285

Start date

Mar 1, 2024

Status verified date

Dec, 2025

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Early Start Denver Model (ESDM)

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.

active comparator: Treatment as Usual (TAU)

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.

Interventions

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.

Early Intensive Behavioral Intervention (EIBI)

Treatment as usual provided by community-based autism agencies

Primary outcome measure

  • Assessment of Phase of Preschool Language (APPL) [ Time Frame: Baseline, 6 months, 12 months ]
  • Vineland Adaptive Behavior Scales-3rd Edition (VABS-3) Communication Domain [ Time Frame: Baseline, 6 months, 12 months ]

Central Contacts and Locations

Central contacts

Aubyn Stahmer, PhD

916-703-0254astahmer@ucdavis.edu

Sarah Dufek, PhD

sadufek@ucdavis.edu

Locations

University of California, Davis MIND Institute

Recruiting

Sacramento, California, United States, 95817

Contacts

Deeniece Hatten, BA

916-703-0468dchatten@ucdavis.edu

More Information

Sponsor

University of California, Davis

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Keywords

  • early intervention
  • community effectiveness
  • early start denver model

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of California, Davis on 2025-12-05.