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

NCT06005285 | Recruiting DMC

• 2 other identifiers: 2030726R01MH131703-01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Keywords

early intervention; community effectiveness; early start denver model

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Vineland Adaptive Behavior Scales-3rd Edition (VABS-3)

  Baseline, 6 months, 12 months

• Caregiver Quality of Life Instrument (CarerQoL)

  Baseline, 6 months, 12 months

• Pediatric Quality of Life Inventory (PedsQL)

  Baseline, 6 months, 12 months

• The Parenting Sense of Competence (PSOC)

  Baseline, 6 months, 12 months

• Brief Observation of Social Change (BOSCC)

  6 months, 12 months

Other Outcomes (6)

• Implementation Climate Scale (ICS)

  baseline

• Autism Self-Efficacy Scale for Teachers (ASSET)

  6 months, 12 months

• Provider Report of Sustainment Scale (PRESS)

  12 months

Study Arms (2)

Early Start Denver Model (ESDM)

EXPERIMENTAL

Early Start Denver Model (ESDM) is a comprehensive model that integrates principles of applied behavior analysis (ABA), relationship-based, developmental, and play-based orientations into an individualized and yet manualized treatment. Core features include the use of naturalistic ABA strategies, sensitivity to typical developmental sequence, caregiver involvement, a focus on interpersonal exchange and positive affect within everyday activities. Providers in the ESDM condition will receive training in caregiver coaching strategies and will be asked to conduct caregiver coaching in the strategies at least monthly.

Behavioral: Early Start Denver Model (ESDM)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Treatment as usual will vary based on the agency. However, a majority of CBAs use Discrete trial teaching (DTT) based on the Lovaas model.19 DTT involves 10 components described in numerous research publications: capturing child physical and visual attention, adult presentation of the stimuli and instruction (antecedent), child behavior, adult reinforcement, correction procedures, 3-5 second interstimulus interval between trials, behavior-specific praise, and data recording. Most CBAs include caregivers in some way as caregiver involvement is required by most funders. Often, caregivers observe treatment sessions or learn the teaching approach being used with their child. Providers often provide consultation on addressing behavioral concerns.

Behavioral: Early Intensive Behavioral Intervention (EIBI)

Interventions

Early Start Denver Model (ESDM) BEHAVIORAL

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.

Also known as: naturalistic developmental behavioral intervention (NDBI)

Early Start Denver Model (ESDM)

Early Intensive Behavioral Intervention (EIBI) BEHAVIORAL

Treatment as usual provided by community-based autism agencies

Also known as: Discrete Trial Teaching (DTT)

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• employed as a program supervisor at participating region
• plans to be employed for at least the next 12 months
• serves children with autism under age 5
• has not has previous training in ESDM
• supervises at least two technicians
• supervised by a participating supervisor
• plans to be employed for at least the next 12 months
• serves children with autism under age 5
• has not had previous ESDM training
• child age 1-5 years
• has a current autism spectrum disorder (ASD) diagnosis on record or is being served as at-risk for ASD if under age 3
• family speaks English or Spanish
• child expected to be in therapy for at least 7 months

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• University of California, Davis: lead

Study Sites (1)

University of California, Davis MIND Institute

Sacramento, California, 95817, United States

RECRUITING

Related Publications (1)

• Stahmer AC, Dufek S, Rogers SJ, Iosif AM. Study Protocol for a Cluster, Randomized, Controlled Community Effectiveness Trial of the Early Start Denver Model (ESDM) Compared to Community Early Behavioral Intervention (EBI) in Community Programs serving Young Autistic Children: Partnering for Autism: Learning more to improve Services (PALMS). BMC Psychol. 2024 Sep 28;12(1):513. doi: 10.1186/s40359-024-02020-0.

  PMID: 39342272 DERIVED

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Aubyn C Stahmer, PhD

  UC Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aubyn Stahmer, PhD

CONTACT

916-703-0254; astahmer@ucdavis.edu

Sarah Dufek, PhD

CONTACT

sadufek@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Interviewers, assessors and video coders will be naive to group status (ESDM or TAU).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 22, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Subsequent to publication of primary research findings.
• Access Criteria: Therefore, the investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Locations

US (1)