Study Protocol for a Cluster, Randomized, Controlled Community Effectiveness Trial of the Early Start Denver Model (ESDM) Compared to Community Early Behavioral Intervention (EBI) in Community Programs serving Young Autistic Children: Partnering for Autism: Learning more to improve Services (PALMS).

Researchers are planning a large study to test whether a play-based therapy called ESDM works better than usual behavioral therapy for young autistic children in community programs. The study will involve 300 families and compare how well children develop language and social skills with each approach. This is important because many current programs use very structured methods that may not be best for young children.

This is a protocol for a large-scale community effectiveness trial (PALMS) comparing the Early Start Denver Model (ESDM) to usual early behavioral intervention for young autistic children. The cluster-randomized controlled trial will involve 100 supervisors, 300 families with autistic children under 5, and 200 behavior technicians across community agencies. The study addresses the growing concern about inappropriate use of highly structured ABA approaches for young children, testing whether ESDM - a naturalistic developmental behavioral intervention with proven efficacy - can be effectively implemented in real-world community settings. Primary outcomes focus on language and social communication at 6 and 12 months, with secondary measures including adaptive behavior and implementation factors.

If successful, this trial could provide critical evidence for implementing ESDM in community settings, potentially improving access to developmentally appropriate interventions for young autistic children. The study's focus on implementation factors will inform how to scale effective interventions within publicly funded services.

This is a study protocol only - no results are available yet. The abstract does not report actual findings or outcomes from the trial implementation.

The rising number of children identified with autism has led to exponential growth in for-profit applied behavior analysis (ABA) agencies and the use of highly structured approaches that may not be developmentally appropriate for young children. Multiple clinical trials support naturalistic developmental behavior interventions (NDBIs) that integrate ABA and developmental science and are considered best practices for young autistic children. The Early Start Denver Model (ESDM) is a comprehensive NDBI shown to improve social communication outcomes for young autistic children in several controlled efficacy studies. However, effectiveness data regarding NDBI use in community-based agencies are limited.

This study uses a community-partnered approach to test the effectiveness of ESDM compared to usual early behavioral intervention (EBI) for improving social communication and language in autistic children served by community agencies. This is a hybrid type 1 cluster-randomized controlled trial with 2 conditions: ESDM and EBI. In the intervention group, supervising providers will receive training in ESDM; in the control group, they will continue EBI as usual. We will enroll and randomize 100 supervisors (50 ESDM, 50 EBI) by region.

Each supervisor enrolls 3 families of autistic children under age 5 (n = 300) and accompanying behavior technicians (n = 200). The primary outcome is child language and social communication at 6 and 12 months. Secondary outcomes include child adaptive behavior, caregiver use of ESDM strategies, and provider intervention fidelity. Child social motivation and caregiver fidelity will be tested as mediating variables.

ESDM implementation determinants will be explored using mixed methods. This study will contribute novel knowledge on ESDM effectiveness, the variables that mediate and moderate child outcomes, and engagement of its mechanisms in community use. We expect results from this trial to increase community availability of this model and access to high-quality intervention for young autistic children, especially those who depend on publicly funded intervention services. Understanding implementation determinants will aid scale-up of effective models within communities.

Clinicaltrials.gov identifier number NCT06005285. Registered on August 21, 2023. Issue date 6 August 2024; Protocol amendment number: 02.