Detection of ASD at the 1st Birthday as Standard of Care: The Get SET Early Model
1 other identifier
observational
12,000
1 country
2
Brief Summary
According to a recent report from the Centers for Disease Control, most children with ASD do not receive a diagnosis and begin receiving treatment until well after their 4th birthday, which is unfortunate given that many connections between brain cells have already been established by that age. This program will test a model called Get S.E.T. Early (S=Screen, E=Evaluate, T=Treat) in both San Diego and Phoenix, designed to detect, evaluate, and treat ASD within the first 2 years of life. In this proposal 7,500 toddlers from the general population will be screened in San Diego and Phoenix (total 15,000) using the CSBS IT Checklist (Wetherby \& Prizant, 2002) at well baby check-ups using a "triple screen" approach wherein toddlers are screened at three ages starting at 12 months. Investigators predict that providing screening tools with clear cut-off scores and guidelines for automatic referral for both evaluation and treatment will result in dramatically lowering mean age of detection in Phoenix from 4-5 years down to 1-2 years. Investigators also predict that using repeat screening at 12, 18, \& 24 months in combination with automatic referral options via technology (i-Pads) will result in an increase in the number of ASD toddlers detected by 24 months relative to a single time point screen using traditional paper screens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 27, 2015
CompletedFirst Posted
Study publicly available on registry
June 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedMarch 2, 2020
February 1, 2020
5.8 years
May 27, 2015
February 27, 2020
Conditions
Outcome Measures
Primary Outcomes (7)
Rate of screening per pediatric office
Year 4
Rate of referral for developmental evaluation per pediatric office
Year 4
Age at screen
Year 4
Age at developmental evaluation
Year 4
Age at treatment start
Age at treatment start will be tracked for 4 years, and an average age computed in year 5
Number of ASD toddlers detected by program
Year 4
Changes in parent and pediatrician screening perceptions from baseline to Year 4
Year 5
Study Arms (2)
San Diego, CA
Toddlers detected with ASD and other disorders based on the Get SET Early Model in San Diego.
Phoenix, AZ
Toddlers detected with ASD and other disorders based on the Get SET Early Model in Phoenix.
Eligibility Criteria
Two cohorts of toddlers, those in San Diego and Phoenix, will participate. Toddlers in both cities from the general population will be screened for ASD and other delays using the CSBS Infant-Toddler Checklist in pediatric offices at the 12, 18, and 24 month well-baby visits.
You may qualify if:
- Completed CSBS IT Checklist at pediatrician office
- Pediatrician referred
- Between 12 and 36 months
You may not qualify if:
- Older than 36 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Southwest Autism Research & Resource Center (Sarrc)
Phoenix, Arizona, 85006, United States
Autism Center of Excellence
La Jolla, California, 92037, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Pierce, PhD
University of California, San Diego
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-Director of the Autism Center of Excellence
Study Record Dates
First Submitted
May 27, 2015
First Posted
June 4, 2015
Study Start
August 1, 2014
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
March 2, 2020
Record last verified: 2020-02