R01MH131703
Project Grant
Overview
Grant Description
Examining the Effectiveness of the Early Start Denver Model in Community Programs Serving Young Autistic Children - Project Summary
The rising number of children being identified as autistic has led to exponential growth in for-profit Applied Behavior Analysis (ABA) agencies serving them. The use of highly structured approaches that may not be developmentally appropriate for young children and that limit use of learned skills across settings and time, and growing public health concerns regarding limited effectiveness data combined with the cost of services.
Efficacy testing has led to growth in evidence-based autism interventions (EBI), especially naturalistic developmental behavior interventions (NDBIs), supported by multiple clinical trials. NDBIs integrate theory and strategies from ABA and developmental science and are considered best practice for young autistic children. 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, structured methods.
The Early Start Denver Model (ESDM) is a comprehensive NDBI shown to improve social communication and language outcomes for young autistic children in multiple controlled efficacy studies. ESDM engages social motivation as a mechanism to increase child engagement in social learning opportunities in the environment resulting in increased rate of child learning. ESDM includes assessment and data collection methods that meet funder requirements and a tested community training model.
Understanding whether ESDM is effective and whether the same treatment mechanisms operating in efficacy trials are also operating in community implementation with diverse samples are critical scientific questions to determine the potential of NDBIs like ESDM to meet the public health goals of improving access to high quality, developmentally appropriate care for a broad range of young autistic children and their families.
To facilitate scale up, we have partnered with autism CBAs and this study will identify factors that affect implementation of ESDM in the community. This project will use a hybrid type 1 randomized controlled design to examine ESDM effectiveness in the community and to gather data on implementation determinants. Primary child outcomes include language and social communication. Secondary outcomes include adaptive behavior, parent use of ESDM strategies, and provider fidelity to the model. Social motivation and caregiver fidelity will be measured as mediating variables. The moderating effects of maternal education, child race/ethnicity, and provider ESDM fidelity will be examined. ESDM implementation determinants will be explored.
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 availability, and therefore, access to high quality 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 communities.
The rising number of children being identified as autistic has led to exponential growth in for-profit Applied Behavior Analysis (ABA) agencies serving them. The use of highly structured approaches that may not be developmentally appropriate for young children and that limit use of learned skills across settings and time, and growing public health concerns regarding limited effectiveness data combined with the cost of services.
Efficacy testing has led to growth in evidence-based autism interventions (EBI), especially naturalistic developmental behavior interventions (NDBIs), supported by multiple clinical trials. NDBIs integrate theory and strategies from ABA and developmental science and are considered best practice for young autistic children. 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, structured methods.
The Early Start Denver Model (ESDM) is a comprehensive NDBI shown to improve social communication and language outcomes for young autistic children in multiple controlled efficacy studies. ESDM engages social motivation as a mechanism to increase child engagement in social learning opportunities in the environment resulting in increased rate of child learning. ESDM includes assessment and data collection methods that meet funder requirements and a tested community training model.
Understanding whether ESDM is effective and whether the same treatment mechanisms operating in efficacy trials are also operating in community implementation with diverse samples are critical scientific questions to determine the potential of NDBIs like ESDM to meet the public health goals of improving access to high quality, developmentally appropriate care for a broad range of young autistic children and their families.
To facilitate scale up, we have partnered with autism CBAs and this study will identify factors that affect implementation of ESDM in the community. This project will use a hybrid type 1 randomized controlled design to examine ESDM effectiveness in the community and to gather data on implementation determinants. Primary child outcomes include language and social communication. Secondary outcomes include adaptive behavior, parent use of ESDM strategies, and provider fidelity to the model. Social motivation and caregiver fidelity will be measured as mediating variables. The moderating effects of maternal education, child race/ethnicity, and provider ESDM fidelity will be examined. ESDM implementation determinants will be explored.
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 availability, and therefore, access to high quality 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 communities.
Awardee
Funding Goals
NOT APPLICABLE
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Sacramento,
California
958172310
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 303% from $938,284 to $3,784,888.
Davis University Of California was awarded
ESDM Effectiveness in Community Programs for Young Autistic Children
Project Grant R01MH131703
worth $3,784,888
from the National Institute of Mental Health in August 2023 with work to be completed primarily in Sacramento California United States.
The grant
has a duration of 4 years 10 months and
was awarded through assistance program 93.242 Mental Health Research Grants.
The Project Grant was awarded through grant opportunity Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required).
Status
(Ongoing)
Last Modified 7/6/26
Period of Performance
8/1/23
Start Date
6/30/28
End Date
Funding Split
$3.8M
Federal Obligation
$0.0
Non-Federal Obligation
$3.8M
Total Obligated
Activity Timeline
Transaction History
Modifications to R01MH131703
Additional Detail
Award ID FAIN
R01MH131703
SAI Number
R01MH131703-3483895982
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Public/State Controlled Institution Of Higher Education
Awarding Office
75N700 NIH National Institute of Mental Health
Funding Office
75N700 NIH National Institute of Mental Health
Awardee UEI
TX2DAGQPENZ5
Awardee CAGE
1CBG4
Performance District
CA-07
Senators
Dianne Feinstein
Alejandro Padilla
Alejandro Padilla
Budget Funding
| Federal Account | Budget Subfunction | Object Class | Total | Percentage |
|---|---|---|---|---|
| National Institute of Mental Health, National Institutes of Health, Health and Human Services (075-0892) | Health research and training | Grants, subsidies, and contributions (41.0) | $938,284 | 100% |
Modified: 7/6/26