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Behavioral Intervention
Early Start Denver Model for Autism
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
Study Summary
This trial assesses if the Early Start Denver Model can help autistic children & families receive better care in a variety of locations.
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.Check my eligibility
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of Phase of Preschool Language (APPL)
Vineland Adaptive Behavior Scales-3rd Edition (VABS-3) Communication Domain
Secondary outcome measures
Brief Observation of Social Change (BOSCC)
Caregiver Quality of Life Instrument (CarerQoL)
ESDM Strategy Use Fidelity Measure
+4 moreOther outcome measures
Acceptability of Intervention Measure (AIM)
Autism Self-Efficacy Scale for Teachers (ASSET)
Feasibility of Intervention Measure (FIM)
+3 moreTrial 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
Who is running the clinical trial?
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,708,919 Total Patients Enrolled
15 Trials studying Autism Spectrum Disorder
5,901 Patients Enrolled for Autism Spectrum Disorder
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,109 Total Patients Enrolled
82 Trials studying Autism Spectrum Disorder
40,352 Patients Enrolled for Autism Spectrum Disorder
Aubyn C Stahmer, PhDPrincipal InvestigatorUC Davis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the focus of this medical experiment?
"This medical trial will evaluate a range of outcomes, with its primary focus being on the Vineland Adaptive Behavior Scales-3rd Edition (VABS-3) Communication Domain, which shall be recorded at Baseline and 6 and 12 months. Secondary metrics include the ESDM Curriculum Checklist for Young Children with Autism (CC), Caregiver Quality of Life Instrument (CarerQoL) and Pediatric Quality of Life Inventory (PedsQL). The CC assesses toddlers' skills across developmental domains based on specific skill use; CarerQoL is scored from 0 to 14 where higher scores indicate increased"
Answered by AI
Are there still opportunities to apply for this investigation?
"Unfortunately, this experiment has concluded its recruitment period according to clinicaltrials.gov records, with the initial post date being November 1st 2023 and the last update on August 16th 2023. Nevertheless, there are still 239 other studies actively seeking participants at present."
Answered by AI
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