Clinical trial NCT06005285: Examining the Effectiveness of the Early Start Denver Model in Community Programs Serving Young Autism
Official title: Examining the Effectiveness of the Early Start Denver Model in Community Programs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Keywords: early intervention
community effectiveness
early start denver model
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-08-22
Enrollment: 600
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The primary aim of the proposed study is to test the effectiveness of ESDM using a hybrid type 1 (effectiveness/implementation) randomized controlled trial in which community based agency (CBA) regions will be randomized to receive training in the Early Start Denver Model (ESDM) or continue treatment as usual (TAU). The investigators decided to randomize by region to address potential contamination across providers and children.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: The investigators will collect data from leaders, providers and clients in participating autism CBAs. The investigators will collect data from 20 Regional Managers, 100 supervisors, and 200 technicians working with autistic children. Participants will include 300 children ages 1-5 years with a diagnosis of autism spectrum disorder living in the US and being served by participating treatment team.

Inclusion criteria for Autism CBAs include: Serve at least 10 children with autism under age 5 annually and have at least 2 regions that can be randomized. Accept Medicaid or equivalent payment (e.g., funding for low income families through public service systems).

Inclusion criteria for supervisors are as follows:

1. employed as a program supervisor at participating region
2. plans to be employed for at least the next 12 months
3. serves children with autism under age 5
4. has not has previous training in ESDM
5. supervises at least two technicians

Inclusion criteria for technicians is as follows:

1. supervised by a participating supervisor
2. plans to be employed for at least the next 12 months
3. serves children with autism under age 5
4. has not had previous ESDM training

Inclusion criteria for children are as follows:

1. child age 1-5 years
2. has a current autism spectrum disorder (ASD) diagnosis on record or is being served as at-risk for ASD if under age 3
3. family speaks English or Spanish
4. child expected to be in therapy for at least 7 months

Primary outcomes:
measure: Assessment of Phase of Preschool Language (APPL)
timeFrame: Baseline, 6 months, 12 months
measure: Vineland Adaptive Behavior Scales-3rd Edition (VABS-3) Communication Domain
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Vineland Adaptive Behavior Scales-3rd Edition (VABS-3)
timeFrame: Baseline, 6 months, 12 months
measure: Caregiver Quality of Life Instrument (CarerQoL)
timeFrame: Baseline, 6 months, 12 months
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Baseline, 6 months, 12 months
measure: The Parenting Sense of Competence (PSOC)
timeFrame: Baseline, 6 months, 12 months
measure: Brief Observation of Social Change (BOSCC)
timeFrame: 6 months, 12 months
measure: ESDM Strategy Use Fidelity Measure
timeFrame: quarterly during provider participation in the study
measure: Naturalistic Developmental Behavioral Intervention Fidelity (NDBI-Fi) measure
timeFrame: quarterly during provider participation in the study
Other outcomes:
measure: Implementation Climate Scale (ICS)
timeFrame: baseline
measure: Autism Self-Efficacy Scale for Teachers (ASSET)
timeFrame: 6 months, 12 months
measure: Provider Report of Sustainment Scale (PRESS)
timeFrame: 12 months
measure: Acceptability of Intervention Measure (AIM)
timeFrame: 6 months, 12 months
measure: Intervention Appropriateness Measure (IAM)
timeFrame: 6 months, 12 months
measure: Feasibility of Intervention Measure (FIM)
timeFrame: 6 months, 12 months
Locations:
city: Sacramento
country: United States
facility: University of California, Davis MIND Institute
state: California
Study officials:
affiliation: UC Davis
name: Aubyn C Stahmer, PhD
role: PRINCIPAL_INVESTIGATOR
References: