Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT02463422

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Autism Spectrum Disorder

Study ID

NCT02463422

Start date

Aug, 2014

Status verified date

Feb, 2020

Completion date

Jun, 2020

Anticipated

Primary completion date

Jun, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Completed CSBS IT Checklist at pediatrician office
  • Pediatrician referred
  • Between 12 and 36 months

Exclusion Criteria:

  • Older than 36 months

Study Design

Enrollment

12000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Rate of screening per pediatric office [ Time Frame: Year 4 ]
  • Rate of referral for developmental evaluation per pediatric office [ Time Frame: Year 4 ]
  • Age at screen [ Time Frame: Year 4 ]
  • Age at developmental evaluation [ Time Frame: Year 4 ]
  • Age at treatment start [ Time Frame: 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 [ Time Frame: Year 4 ]
  • Changes in parent and pediatrician screening perceptions from baseline to Year 4 [ Time Frame: Year 5 ]

Central Contacts and Locations

Central contacts

Locations

Southwest Autism Research & Resource Center (Sarrc)

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Autism Center of Excellence

Recruiting

La Jolla, California, United States, 92037

Contacts

Principal Investigator:

Karen Pierce, PhD

More Information

Sponsor

University of California, San Diego

Last update posted

Mar 2, 2020

Last verified

Feb, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2020-03-02.