A new community effectiveness trial is set to evaluate the Early Start Denver Model (ESDM) in real-world settings for young children with autism spectrum disorder (ASD). This hybrid type 1 cluster randomized controlled trial will compare ESDM to usual early behavioral intervention (EBI) across multiple community-based agencies (CBAs) in the United States. The study aims to determine the effectiveness of ESDM in improving social communication and language skills in autistic children under the age of 5.
The trial, funded by the National Institute of Mental Health (NIMH), will involve 300 child/caregiver dyads recruited from 20 CBAs. These agencies must serve at least 10 autistic children under age 5 annually, have at least two regions that can be randomized, and accept Medicaid or equivalent payment. Participating regions within each CBA will be randomized to either receive training in ESDM or continue with their usual EBI. Randomization will be stratified by insurance mix and size of the agency to ensure balance between the two arms.
Intervention Details
In the ESDM arm, supervisors from the CBAs will receive comprehensive training in the ESDM model, including assessment, goal development, data collection, and intervention strategies. Technicians will receive asynchronous didactic training combined with coaching and feedback from their supervisors. Caregivers in the ESDM group will also receive training in ESDM coaching strategies and access to an online program called "Help is in Your Hands."
In the EBI arm, providers will continue with their usual treatment approaches, which often involve Discrete Trial Teaching (DTT) based on the Lovaas model. The study will measure the use of DTT and naturalistic developmental behavioral intervention (NDBI) strategies across both groups to characterize the interventions delivered.
Outcome Measures
The primary outcome of the trial is child social communication and language, assessed through caregiver report and observational coding. Secondary outcomes include adaptive behavior, cognitive gains, quality of life, caregiver use of NDBI strategies, and increases in caregiver competence. Data will be collected at baseline, 6 months, and 12 months post-baseline.
Social motivation, measured by the Pervasive Developmental Disorder Behavior Inventory (PDDBI) and Joint Engagement Rating Inventory (JERI), and caregiver NDBI fidelity will be examined as potential mediators of treatment outcomes.
Implementation Outcomes
The study will also assess implementation outcomes, including the acceptability, appropriateness, and feasibility of ESDM in community settings. Data will be collected through surveys and semi-structured interviews with regional managers, supervisors, technicians, and caregivers.
Analytic Approach
Data will be analyzed using generalized linear mixed-effects models to account for the multi-level clustering of the data (repeated observations within child/caregiver, child/caregiver within team, teams within region, and regions within CBA). Moderation analyses will explore the differential effectiveness of the interventions based on factors such as maternal education, child race/ethnicity, and technician ESDM fidelity.
This trial has the potential to provide valuable insights into the effectiveness of ESDM in community settings and to inform efforts to scale up evidence-based interventions for young children with autism.
