Skip to main content
OpenTrials
Completed

NCT Number: NCT03517163

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Autism Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

The Boston Outcomes of Autism in Toddlers Study

Acronym: BOAT

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 7, 2018
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.