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.
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.
United States2 sites, 2 recruiting
- 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
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.
- Conditions
- Autism Spectrum Disorder
- 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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of screening per pediatric office
Measured: Year 4
Rate of referral for developmental evaluation per pediatric office
Measured: Year 4
Age at screen
Measured: Year 4
Age at developmental evaluation
Measured: Year 4
Age at treatment start
Measured: 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
Measured: Year 4
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.
- First posted4 Jun 2015 (estimated)
- Study startAug 2014
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Southwest Autism Research and Resource Center (SARRC), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Karen Pierce, University of California, San Diego
- Investigators
- Karen Pierce, PhD, Principal investigator, University of California, San Diego
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of ASD at the 1st Birthday as Standard of Care: The Get SET Early Model
- ClinicalTrials.gov ID
- NCT02463422
- Acronym / sponsor ID
- R01MH104446
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Southwest Autism Research and Resource Center (SARRC), National Institute of Mental Health (NIMH)
- Study start
- Aug 2014
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Completed CSBS IT Checklist at pediatrician office
- Pediatrician referred
- Between 12 and 36 months
Key exclusion criteria (1 listed)
- Older than 36 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Pierce, PhD principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
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.