Boston Outcomes of Autism in Toddlers Study (BOAT)

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 225

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 7 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children diagnosed with Autism Spectrum Disorder through the DSMV as toddlers.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASD Symptomatology	The severity of ASD symptoms in the child (Autism Diagnostic Observation Schedule and Autism Diagnostic Interview-Revised)	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)	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	3 years (Age of diagnosis to Kindergarten Age)
Adaptive Functioning	Parent report on the child's current adaptive functioning (Vineland Adaptive Behavior Scales-3)	3 years (Age of diagnosis to Kindergarten Age)

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Elizabeth Harstad, MD, MPH, Pediatrician/Researcher

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): May 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: autism; autism spectrum disorder; ASD; Asperger's
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: P00026909

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No