Autism Spectrum DisorderBOATNCT03517163
Boston Outcomes of Autism in Toddlers Study
An observational study of Autism Spectrum Disorder and Autism, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to learn more about the outcomes of children who received an Autism Spectrum Disorder (ASD) diagnosis when they were toddlers. The study is interested in whether an early diagnosis can help children with their cognitive, language, social, and behavioral abilities. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 1 Jan 2022
- 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 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Children diagnosed with Autism Spectrum Disorder through the DSMV as toddlers.
Who may be able to join
- Diagnosed with Autism Spectrum Disorder as a toddler through DSM-5 at Boston Children's Hospital
- Enrolled in or just finished Kindergarten
Who cannot join
- Individuals with known genetic disorders including, but not limited to, Fragile X syndrome, Down syndrome, Tuberous Sclerosis Complex and those with 16 p deletions/duplications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: The Boston Outcomes of Autism in Toddlers Study
The purpose of this research study is to learn more about the outcomes of children who received an Autism Spectrum Disorder (ASD) diagnosis when they were toddlers. The study is interested in whether an early diagnosis can help children with their cognitive, language, social, and behavioral abilities.
Read the detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by deficits in domains of social communication and restrictive and repetitive behavior. There is general agreement, in light of knowledge around optimal periods of neural plasticity, that ASD should be diagnosed as early as possible since young toddlers are at a critical stage in early development when intervention is theoretically most effective. The rate of persistence of an ASD diagnosis is heavily debated.Therefore this study attempts:
- To determine the rate of persistence of Autism Spectrum Disorder (ASD) diagnosis and functional outcomes, as defined by cognitive level, adaptive functioning, language skills, persistence of ASD symptoms, and classroom placement at kindergarten age, among children who received a DSM-5 ASD diagnosis at < 36 months.
- To evaluate predictors of rate of persistence and functional outcomes among kindergarten grade level children ages 5-7 years, who received an ASD diagnosis as toddlers.
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- Asperger's, autism, autism spectrum disorder, ASD
- Medical subject headings
- Autism Spectrum Disorder, Autistic 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 |
|---|---|---|
| Prospective Group | Individuals enrolled or just finished kindergarten who were diagnosed with Autism Spectrum Disorder through the DSM-5 diagnostic criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASD Symptomatology
The severity of ASD symptoms in the child (Autism Diagnostic Observation Schedule and Autism Diagnostic Interview-Revised)
Measured: 3 years (Age of diagnosis to Kindergarten Age)
Cognitive Level
Play-based assessment in which a child's cognitive level is determined. (Differential Ability Scales - Second Edition)
Measured: 3 years (Age of diagnosis to Kindergarten Age)
Language Level
Play-based assessment in which a child's language level is determined.Preschool Language Scale - Fifth Edition
Measured: 3 years (Age of diagnosis to Kindergarten Age)
Adaptive Functioning
Parent report on the child's current adaptive functioning (Vineland Adaptive Behavior Scales-3)
Measured: 3 years (Age of diagnosis to Kindergarten Age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start1 Jun 2018
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
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 Boston Children's HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Harstad, Boston Children's Hospital
- Investigators
- Elizabeth Harstad, MD, MPH, Principal investigator, Pediatrician/Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517163
- Sponsor's protocol ID
- P00026909
- Acronym
- BOAT
- Status last verified
- Jul 2023
- First submitted
- 13 Apr 2018
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Boston Outcomes of Autism in Toddlers Study
- ClinicalTrials.gov ID
- NCT03517163
- Acronym / sponsor ID
- BOAT / P00026909
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- Asperger's, autism, autism spectrum disorder, ASD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 7 May 2018 (actual)
- 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.
The purpose of this research study is to learn more about the outcomes of children who received an Autism Spectrum Disorder (ASD) diagnosis when they were toddlers. The study is interested in whether an early diagnosis can help children with their cognitive, language, social, and behavioral abilities.
Detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by deficits in domains of social communication and restrictive and repetitive behavior. There is general agreement, in light of knowledge around optimal periods of neural plasticity, that ASD should be diagnosed as early as possible since young toddlers are at a critical stage in early development when intervention is theoretically most effective. The rate of persistence of an ASD diagnosis is heavily debated.Therefore this study attempts:
- To determine the rate of persistence of Autism Spectrum Disorder (ASD) diagnosis and functional outcomes, as defined by cognitive level, adaptive functioning, language skills, persistence of ASD symptoms, and classroom placement at kindergarten age, among children who received a DSM-5 ASD diagnosis at < 36 months.
- To evaluate predictors of rate of persistence and functional outcomes among kindergarten grade level children ages 5-7 years, who received an ASD diagnosis as toddlers.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Group | – | –Individuals enrolled or just finished kindergarten who were diagnosed with Autism Spectrum Disorder through the DSM-5 diagnostic criteria |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children diagnosed with Autism Spectrum Disorder through the DSMV as toddlers.
Key inclusion criteria (2 listed)
- Diagnosed with Autism Spectrum Disorder as a toddler through DSM-5 at Boston Children's Hospital
- Enrolled in or just finished Kindergarten
Key exclusion criteria (1 listed)
- Individuals with known genetic disorders including, but not limited to, Fragile X syndrome, Down syndrome, Tuberous Sclerosis Complex and those with 16 p deletions/duplications.
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
ASD Symptomatology
Time frame: 3 years (Age of diagnosis to Kindergarten Age)
The severity of ASD symptoms in the child (Autism Diagnostic Observation Schedule and Autism Diagnostic Interview-Revised)
Cognitive Level
Time frame: 3 years (Age of diagnosis to Kindergarten Age)
Play-based assessment in which a child's cognitive level is determined. (Differential Ability Scales - Second Edition)
Language Level
Time frame: 3 years (Age of diagnosis to Kindergarten Age)
Play-based assessment in which a child's language level is determined.Preschool Language Scale - Fifth Edition
Adaptive Functioning
Time frame: 3 years (Age of diagnosis to Kindergarten Age)
Parent report on the child's current adaptive functioning (Vineland Adaptive Behavior Scales-3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
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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.
Elizabeth Harstad, MD, MPH principal investigator
Pediatrician/Researcher
1 site 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 and Autism, run by Boston Children's Hospital at 1 site 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 2 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: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASD Symptomatology (time frame: 3 years (Age of diagnosis to Kindergarten Age)). The study lists 4 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 6 Jul 2023.