Boston Outcomes of Autism in Toddlers Study

Autism Spectrum Disorder Clinical Trial

— BOAT  

Official title:

The Boston Outcomes of Autism in Toddlers Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03517163
• Other study ID #: P00026909
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: January 1, 2022

Study information

• Verified date: July 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Adaptive Functioning	Parent report on the child's current adaptive functioning (Vineland Adaptive Behavior Scales-3)	3 years (Age of diagnosis to Kindergarten Age)