Boston Outcomes of Autism in Toddlers Study

Completed

• Conditions: Autism Spectrum Disorder; Autism

• Registration Number: NCT03517163
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-04-24
• Study First Posted: 2018-05-07
• Study Start: 2018-06-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-04
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive Level	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)
Adaptive Functioning	3 years (Age of diagnosis to Kindergarten Age)	Parent report on the child's current adaptive functioning (Vineland Adaptive Behavior Scales-3)
ASD Symptomatology	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)
Language Level	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

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States