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Behavioral Intervention
Early Start Denver Model for Autism
Sacramento, CA
N/A
Recruiting
Led By Aubyn C Stahmer, PhD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial assesses if the Early Start Denver Model can help autistic children & families receive better care in a variety of locations.
See full description
Who is the study for?
This trial is for young children aged 1-5 with autism or at risk for ASD, who haven't had ESDM training and will be in therapy for at least 7 months. Agencies must serve at least 10 such children annually, accept Medicaid, and have staff willing to participate for over a year.
What is being tested?
The study examines the Early Start Denver Model (ESDM) used by community agencies serving autistic children. It aims to assess how practical and effective ESDM is compared to Early Intensive Behavioral Intervention (EIBI) in real-world settings.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, traditional side effects are not expected. However, there may be variations in individual responses to the therapy methods.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assessment of Phase of Preschool Language (APPL)
Vineland Adaptive Behavior Scales-3rd Edition (VABS-3) Communication Domain
Secondary study objectives
Brief Observation of Social Change (BOSCC)
Caregiver Quality of Life Instrument (CarerQoL)
ESDM Strategy Use Fidelity Measure
+4 moreOther study objectives
Acceptability of Intervention Measure (AIM)
Autism Self-Efficacy Scale for Teachers (ASSET)
Feasibility of Intervention Measure (FIM)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Early Start Denver Model (ESDM)Experimental Treatment1 Intervention
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.
Group II: Treatment as Usual (TAU)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Early Start Denver Model (ESDM)
2013
N/A
~160
Find a Location
Closest Location:University of California, Davis MIND Institute· Sacramento, CA
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
3,002 Previous Clinical Trials
2,851,324 Total Patients Enrolled
85 Trials studying Autism Spectrum Disorder
41,123 Patients Enrolled for Autism Spectrum Disorder
University of California, DavisLead Sponsor
957 Previous Clinical Trials
4,809,332 Total Patients Enrolled
16 Trials studying Autism Spectrum Disorder
5,961 Patients Enrolled for Autism Spectrum Disorder
Aubyn C Stahmer, PhDPrincipal InvestigatorUC Davis