NCT03517163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 7, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

3.6 years

First QC Date

April 13, 2018

Last Update Submit

July 4, 2023

Conditions

Keywords

Asperger'sautismautism spectrum disorderASD

Outcome Measures

Primary Outcomes (4)

  • 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)

Study Arms (1)

Prospective Group

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

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Elizabeth Harstad, MD, MPH

    Pediatrician/Researcher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatrician

Study Record Dates

First Submitted

April 13, 2018

First Posted

May 7, 2018

Study Start

June 1, 2018

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

July 6, 2023

Record last verified: 2023-07

Locations