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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT06005285
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Months - N/A
Healthy Volunteers
Not accepted

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.
  • Early Intensive Behavioral Intervention (EIBI) — BEHAVIORAL
    Treatment as usual provided by community-based autism agencies

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
Dec 2025
Primary completion
Jan 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Early Start Denver Model (ESDM)
    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.
  • Active Comparator: Treatment as Usual (TAU)
    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.

Primary Outcome Measure

Assessment of Phase of Preschool Language (APPL) [ Time Frame: Baseline, 6 months, 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Davis MIND InstituteSacramentoCalifornia95817
Deeniece Hatten, BA
[email protected]
916-703-0468

Find similar trials in Sacramento, CA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
University of California, Davis MIND Institute· Sacramento, CA

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