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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06005285
• Other study ID #: 2030726
• Secondary ID: R01MH131703-01
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: June 1, 2028

Study information

• Verified date: August 2023
• Source: University of California, Davis
• Contact: Aubyn Stahmer, PhD
• Phone: 916-703-0254
• Email: astahmer[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 1, 2028
• Est. primary completion date: January 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Behavioral:
• Early Start Denver Model (ESDM)
The Early Start Denver Model focuses on teaching inside children's play and care activities, carried out within a joint activity structure. Adults follow children's leads into activities, embed teaching objectives inside the play, use the play as the reward, and build targeted skills following developmental science and ABA principles.
• Early Intensive Behavioral Intervention (EIBI)
Treatment as usual provided by community-based autism agencies

Locations

Country	Name	City	State
United States	University of California, Davis MIND Institute	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implementation Climate Scale (ICS)	The Implementation Climate Scale measures employees' shared perceptions of the policies, practices, procedures, and behaviors that are expected, rewarded, and supported in order to facilitate effective EBI implementation. The scale includes 18 items capturing six dimensions (three items per dimension). The response scale ranges from 0 ("not at all") to 4 ("to a very great extent"). Scores for each dimension are created by averaging the three subscale items, and the composite score is created by calculating the mean of the subscale scores. Scores range from 0 (minimum) to 4 (maximum). High scores indicate better climate for implementation.	baseline
Other	Autism Self-Efficacy Scale for Teachers (ASSET)	The Autism Self-Efficacy Scale for Teachers is a 30-item scale that measures provider beliefs about their ability to implement appropriate strategies when working with autistic children. Scores range from 0 (minimum) to 100 (maximum) with hither scores reflecting higher self-efficacy.	6 months, 12 months
Other	Provider Report of Sustainment Scale (PRESS)	The Provider Report of Sustainment Scale captures provider report of continued use of an intervention. Each of 3 items is rated on a Likert scale from 0-4. An average score across items is used for analyses, with a minimum score of 0 and a maximum score of 4. Higher scores indicate increased sustainment.	12 months
Other	Acceptability of Intervention Measure (AIM)	The Acceptability of Intervention Measure determines the extent to which a participant believes an intervention is acceptable. Each of 3 items is rated on a Likert scale from 0-4. An average score across items is used for analyses, with a minimum score of 0 and a maximum score of 4. Higher scores indicate better outcomes.	6 months, 12 months
Other	Intervention Appropriateness Measure (IAM)	The Intervention Appropriateness Measure determines the extent to which a participant believes an intervention is appropriate for their population or practice. Each of 3 items is rated on a Likert scale from 0-4. An average score across items is used for analyses, with a minimum score of 0 and a maximum score of 4. Higher scores indicate better outcomes.	6 months, 12 months
Other	Feasibility of Intervention Measure (FIM)	The Feasibility of Intervention Measure determines the extent to which a participant believes an intervention is feasible to use in their program. Each of 3 items is rated on a Likert scale from 0-4. An average score across items is used for analyses, with a minimum score of 0 and a maximum score of 4. Higher scores indicate better outcomes.	6 months, 12 months
Primary	Assessment of Phase of Preschool Language (APPL)	the APPL operationalizes research-based language development stages. Language phases are derived from spoken language or augmentative communication systems and standardized assessments. Language samples will be obtained from transcriptions of child-caregiver interactions recorded at each timepoint and coded by naive observers	Baseline, 6 months, 12 months
Primary	Vineland Adaptive Behavior Scales-3rd Edition (VABS-3) Communication Domain	Standardized parent interview measuring the use of adaptive communication. The Vineland Adaptive Behavior Scales-3rd Edition communication domain provides a standardized score with a mean of 100 and a standard deviation of 15. Higher scores mean better outcomes.	Baseline, 6 months, 12 months
Secondary	Vineland Adaptive Behavior Scales-3rd Edition (VABS-3)	The Vineland Adaptive Behavior Scales-3rd Edition consists of four domains of adaptive behavior: communication, daily living skills, socialization, and motor skills. Overall adaptive behavior composite will be used in analyses. The Vineland Adaptive Behavior Scales-3rd Edition adaptive behavior composite provides a standardized score with a mean of 100 and a standard deviation of 15. Higher scores mean better outcomes.	Baseline, 6 months, 12 months
Secondary	Caregiver Quality of Life Instrument (CarerQoL)	The Caregiver Quality of Life Instrument assesses perceived caregiver quality of life across seven dimensions for informal caregivers. Minimum score is 0 and maximum score is 14 where higher scores indicate increased caregiving burden (worse outcomes).	Baseline, 6 months, 12 months
Secondary	Pediatric Quality of Life Inventory (PedsQL)	The PedsQL assesses children's quality of life across four domains based on caregiver report and has been validated in an autism population. The PedsQL is scored on a scale of 0 to 100, with higher numbers correlating with better quality of life.	Baseline, 6 months, 12 months
Secondary	The Parenting Sense of Competence (PSOC)	The Parenting Sense of Competence (PSOC) is a 17-item caregiver questionnaire that measures and assesses caregiver self-efficacy in working with their child. Parents will complete this at each time point. Scores range from 17 (min) to 102 (max). A higher score indicates a higher parenting sense of competency.	Baseline, 6 months, 12 months
Secondary	Brief Observation of Social Change (BOSCC)	The Brief Observation of Social Change consists of 15 items that are coded on a 6-point scale and results in Social Communication (SC; i.e., eye contact, facial expressions, gestures, vocalizations, integration of vocal and non-vocal communication, frequency/function of social overtures, frequency/quality of social responses, engagement in activities/interaction, and play with objects) and Restricted and Repetitive Behavior (RRB) domain totals (unusual sensory interests, hand/finger or other complex mannerisms, and unusually repetitive interests/stereotyped behaviors). The Core total combines the SC and RRB scores. I	6 months, 12 months
Secondary	ESDM Strategy Use Fidelity Measure	The ESDM Fidelity Checklist will assess use of ESDM practices. The ESDM Fidelity Checklist consists of 13 items: (a) management of child attention; (b) ABC teaching format; (c) instructional techniques; (d) Modulating child affect/arousal; (e) management of unwanted behavior; (f) use of turn-taking/dyadic engagement; (g) child motivation is optimized; (h) adult use of positive affect; (i) adult sensitivity and responsivity; (j) multiple varied communicative functions; (k) adult language; (l) joint activity and elaboration; and (m) transition between activities.	quarterly during provider participation in the study
Secondary	Naturalistic Developmental Behavioral Intervention Fidelity (NDBI-Fi) measure	This measure was developed to capture common elements across NDBI interventions. This measure has adequate reliability, sensitivity to change, and concurrent, convergent, and discriminative validity. The investigators will use the total score as well as examine differences by strategy type, responsive and directive consistent with recent studies	quarterly during provider participation in the study