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Boston Outcomes of Autism in Toddlers Study (BOAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03517163
Recruitment Status : Recruiting
First Posted : May 7, 2018
Last Update Posted : August 26, 2022
Information provided by (Responsible Party):
Elizabeth Harstad, Boston Children's Hospital

Brief 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.

Condition or disease
Autism Spectrum Disorder Autism

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:

  1. 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.
  2. 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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Boston Outcomes of Autism in Toddlers Study
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

Prospective Group
Individuals enrolled or just finished kindergarten who were diagnosed with Autism Spectrum Disorder through the DSM-5 diagnostic criteria

Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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

  4. 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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children diagnosed with Autism Spectrum Disorder through the DSMV as toddlers.

Inclusion Criteria:

  • Diagnosed with Autism Spectrum Disorder as a toddler through DSM-5 at Boston Children's Hospital
  • Enrolled in or just finished Kindergarten

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03517163

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Contact: Rafael DePillis 617-919-6633

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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Christopher Zaro         
Sponsors and Collaborators
Boston Children's Hospital
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Principal Investigator: Elizabeth Harstad, MD, MPH Pediatrician/Researcher
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Responsible Party: Elizabeth Harstad, Pediatrician, Boston Children's Hospital Identifier: NCT03517163    
Other Study ID Numbers: P00026909
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: August 26, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elizabeth Harstad, Boston Children's Hospital:
autism spectrum disorder
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders