AzTrials
AzTrials

Autism Spectrum DisorderNCT02463422

Detection of ASD at the 1st Birthday as Standard of Care: The Get SET Early Model

An observational study of Autism Spectrum Disorder, run by University of California, San Diego at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 to 36 monthsHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder
How many people
12,000 participants
Where
2 sitesUnited States
Study dates
Aug 2014to Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 36 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: 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.

Who may be able to join

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

Who cannot join

  • Older than 36 months

Trial locations and contacts

2 sites in 1 country.

Mallory Barrett contact

858-822-3613

mpiazzola@ucsd.edu

Elizabeth Bacon contact

858-534-6910

ebacon@ucsd.edu

United States2 sites, 2 recruiting
  • Autism Center of Excellence

    La Jolla, California, 92037

    Mallory Barrett, 858-822-3613, mpiazzola@ucsd.edu

    Elizabeth Bacon, 858-534-6910, ebacon@ucsd.edu

    Recruiting
  • Southwest Autism Research & Resource Center (Sarrc)

    Phoenix, Arizona, 85006

    Stephen James, PhD, 602-606-9812, SJames@autismcenter.org

    Christopher Smith, PhD

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Investigators previously demonstrated that their early intervention model system, which was centered on using the CSBS IT Checklist to screen all babies at the 1-year check-up as standard of care, resulted in a mean age of 12 months for screening, 14 months for evaluation, and 18 months for treatment participation. These are far younger ages than is common in the U.S. The 3-stage model system, Get SET (S=Screen; E=Evaluate; T=Treat) Early, screened >10,000 1 year olds in the first trial run detecting over 100 ASD and other developmental delayed toddlers. The current grant will build on this highly effective model by implementing a new version in two major cities: San Diego and Phoenix; data mined from electronic records from Kaiser pediatric offices in Los Angeles and Irvine will provide control data. In Phoenix, investigators test the feasibility of establishing the Get SET Early model in a city with one of the lowest median incomes and oldest age of first diagnosis in America. In AIM #1, the Screen and Refer Early stage, investigators will create a Pediatrician Network with 100 members in Phoenix. In San Diego investigators will utilize their existing Pediatrician Network and test new innovations such as a repeat "triple screen" at 12, 18, and 24 months to ensure that no toddlers are missed. Speed of referral for evaluation will be compared and contrasted using parent (self) and automatic (referral i-Pad App) options. Investigators will track every toddler with an eventual ASD diagnosis within circumscribed medical groups to determine the true sensitivity and specificity of the screening tool and the percentage of ASD toddlers detected by this model. Anonymous survey data regarding screening habits will be administered to parents and pediatricians. AIM #2 implements the Evaluate and Refer Early stage. Its key attribute is an ASD Early Evaluation Clinic that specializes in the rapid scheduling and evaluation of every referred screened positive toddler. Toddlers will enter the program at the age they fail the screen (i.e., 12, 18 or 24 months) and will be thoroughly diagnostically evaluated and tracked once per year until they turn 3 years. This specialty Clinic is at the Autism Center in San Diego and will be developed at SARRC in Phoenix. Automated versus optional self-referral for treatment will be tested and compared. AIM #3 implements the Treat Early stage. Its key attributes are a network of providers of empirically based treatment and the innovative use of an inexpensive and readily available web-based treatment tracking system to document engagement. Treatment Networks will be created in San Diego and Phoenix. Primary outcome measures include rates and ages of screening and referral, evaluation and referral, and treatment engagement; sustainability across years; diagnostic, clinical and demographic characteristics of subjects; professional and parent satisfaction at each stage. Investigators hypothesize that providing screening tools with clear cut-off scores and guidelines for automatic referral for evaluation and treatment, will result in dramatically lowering mean age of diagnosis and treatment in Phoenix from 4-5 years down to 1-2 years; San Diego will likewise have mean ages of 1-2 years for diagnosis and treatment making them significantly earlier than non-intervention contrast cities.

Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02463422
Study groupRoleWhat they receive
San Diego, CAToddlers detected with ASD and other disorders based on the Get SET Early Model in San Diego.
Phoenix, AZToddlers detected with ASD and other disorders based on the Get SET Early Model in Phoenix.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of screening per pediatric office

    Measured: Year 4

  2. Rate of referral for developmental evaluation per pediatric office

    Measured: Year 4

  3. Age at screen

    Measured: Year 4

  4. Age at developmental evaluation

    Measured: Year 4

  5. Age at treatment start

    Measured: Age at treatment start will be tracked for 4 years, and an average age computed in year 5

  6. Number of ASD toddlers detected by program

    Measured: Year 4

  7. Changes in parent and pediatrician screening perceptions from baseline to Year 4

    Measured: Year 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2015 (estimated)
  2. Study startAug 2014
  3. Primary completionJun 2020 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
12,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02463422
Sponsor's protocol ID
R01MH104446
Other IDs
R01MH104446
Status last verified
Feb 2020
First submitted
27 May 2015
Last updated
2 Mar 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Autism Spectrum Disorder, run by University of California, San Diego at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mallory Barrett (858-822-3613, mpiazzola@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of screening per pediatric office (time frame: Year 4). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in