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:
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).
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.
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.
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.