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

Autism Clinical Trial

Official title: Examining the Effectiveness of the Early Start Denver Model in Community Programs

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The rising number of children identified as autistic has led to exponential growth in for-profit applied behavior analysis (ABA) agencies and their use of highly structured approaches that may not be developmentally appropriate for young children.1 This has led to growing public health concerns regarding limited effectiveness data combined with high cost of services. Newer research has led to development of evidence-based autism interventions (EBI) called naturalistic developmental behavior interventions (NDBIs),30 supported by multiple clinical trials.31-34 NDBIs integrate theory and strategies from ABA and developmental science,30 are considered best practice for young autistic children,35 and are supported by systematic reviews and meta-analyses.9,36 However, NDBI effectiveness has not been tested in the community and there is also a need to test the variables that moderate outcomes, and the mechanisms of treatment action.2 The lack of effectiveness data regarding NDBI use in community-based agencies (CBAs) contributes to limited funding as payors are more likely to recognize older methods. The Early Start Denver Model (ESDM) is a comprehensive NDBI shown to improve social communication and language for autistic children in multiple controlled efficacy studies.6,31 ESDM engages social motivation and caregiver use of strategies as mechanisms to increase child engagement in social learning opportunities in the environment, resulting in increased rates of learning.65 ESDM is a manualized approach that includes assessment and data collection methods that meet funder requirements and a tested community training model. The transportability of ESDM is evidenced by two recent community pilot studies.63,64 This proposal addresses a critical need to understand ESDM effectiveness and whether the same treatment mechanisms operating in efficacy trials also operate in community implementation with diverse samples. Answering these critical scientific questions will determine the potential of NDBIs to meet public health goals of improving access to quality care for young autistic children.

In addition to the challenge of determining effectiveness within communities are challenges of implementation and scale-up. CBAs have grown exponentially in number and size since changes in insurance regulations allow funding for such services. The nine largest CBAs operate over 300 centers and employ thousands of therapists generating $1.07 billion this year, outpacing prescription drugs for autism symptoms. The fast growth in CBA service delivery highlights a large research gap between efficacy and clinical effectiveness findings for current community practices. Given the number of children, families, and the costs involved in this public health challenge, using hybrid effectiveness-implementation designs can accelerate scalability of effective NDBI for community settings by ensuring fit, feasibility and acceptability for CBAs and diverse families. The investigators propose to use the Exploration, Preparation, Implementation and Sustainment (EPIS) framework to identify multi-level factors that affect implementation of ESDM in the community.95

This project will use a hybrid type 1 randomized controlled design to examine ESDM effectiveness and to gather data on implementation determinants. The specific aims and hypotheses are to:

1. Test the effectiveness of ESDM for improving social communication and language outcomes in a diverse community sample of autistic children using a randomized controlled trial of Community Based Agencies. Compared to treatment as usual (TAU): a) Children in the ESDM condition will demonstrate significantly increased growth rates in social communication and language (primary); b) caregivers in the ESDM condition will have greater increases in use of ESDM strategies (secondary).

2. Examine engagement of the treatment mechanisms of social motivation and caregiver fidelity within both treatment groups. The investigators predict that: (a) increased social motivation and better caregiver fidelity will act as mechanisms of change in social communication and language in both ESDM and TAU and (b) children in the ESDM group will demonstrate greater changes in social motivation than children in TAU.

3. Examine moderating variables on ESDM treatment effects. The investigators predict that (a) lower caregiver education and child racial/ethnic diversity will have larger negative effects on child growth rates in TAU than ESDM; and that (b) CBA provider adherence to ESDM fidelity will have positive effects on child rate of growth.

4. Exploratory AIM: Use the EPIS framework to gather data on ESDM Implementation outcomes including acceptability, feasibility, appropriateness and cultural responsivity, CBA provider ESDM fidelity, and caregiver engagement. a) participants will find ESDM to be acceptable, feasible, appropriate and culturally responsive for young autistic children; b) CBA providers will demonstrate ESDM fidelity; c) caregivers receiving ESDM will have higher attendance, parenting competence, and satisfaction than those in TAU.

Impact: As indicated by Autism Interagency Coordinating Committee goals, understanding the effectiveness of an intervention like ESDM, the variables that mediate and moderate child outcomes, and engagement of its mechanisms of action in community use, has the potential to increase access to high quality, effective intervention for all young autistic children, especially those from diverse backgrounds who depend on public services. Understanding implementation determinants will support scale-up of effective models throughout a broad range communities and service systems. ;

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

• NCT number: NCT06005285
• Study type: Interventional
• Source: University of California, Davis
• Contact: Aubyn Stahmer, PhD
• Phone: 916-703-0254
• Email: astahmer@ucdavis.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Completion date: June 1, 2028