Status:
COMPLETED
Intervention Effects of Intensity and Delivery Style for Toddlers With Autism
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
University of Washington
Vanderbilt University
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
15-30 years
Phase:
NA
Brief Summary
A multi-site randomized study of intensive treatment for toddlers with autism involving a three-site collaborative network plus a data coordinating center to evaluate the effects of intervention inten...
Detailed Description
High quality, intensive early intervention is a powerful treatment for ASD, improving IQ and language markedly in randomized controlled clinical trials (RCTs), though little long term follow-up data e...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 12-30 months of age at time of assessment;
- ambulatory and without impairments affecting hand use;
- meets criteria for Autistic Spectrum Disorder on the APA Diagnostic and Statistical Manual, 5th revision criteria and on the Autism Diagnostic Observation Schedule for Toddlers:
- clinical consensus of ASD diagnosis by 2 independent staff (including a licensed psychologist) based on observation as well as record review;
- developmental quotient of \>35 on Mullen Scales of Early Learning;
- normal hearing and vision screen;
- caregiver agreement to comply with all project requirements, including regular videotaping at home with provided equipment.
- Exclusion criteria:
- English not a primary language spoken at home;
- absence at 2 or more appointments without prior notice during the intake assessment;
- more than 10 hours per week of 1:1 ABA based treatment;
- other health or genetic conditions (i.e. fragile X syndrome, seizures, prematurity).
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT02272192
Start Date
March 1 2013
End Date
July 1 2019
Last Update
January 6 2020
Active Locations (3)
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1
UC Davis MIND Institute
Sacramento, California, United States, 95817
2
Vanderbilt University
Nashville, Tennessee, United States, 37240
3
University of Washington Autism Center
Seattle, Washington, United States, 98195