Observational Prospective Study on Behavioral Outcomes of Children With Autism Spectrum Disorder (ASD) in Comparison to Those Without Neurodevelopmental Diagnoses

• Conditions: Anesthesia; Autism Spectrum Disorder
• Interventions: Other: Observation

• Registration Number: NCT02707939
• Lead Sponsor: Boston Children's Hospital

Brief Summary

Autism Spectrum Disorder (ASD) is the fastest growing neurodevelopmental disorder in the world. Approximately 1% of the population worldwide is affected by this disorder. Children with ASD exhibit some very stereo-typical behaviors. Their daily functionality depends on very rigid and predictable schedules and routines. Any changes in their schedules can often trigger negative emotional outbursts. The need to come to the hospital for procedures can be one such trigger. The purpose of this study is to examine the post anesthesia behavior outcomes of children with ASD.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-03-10
• Study First Posted: 2016-03-14
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-10
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients aged 2 years through 17 years of age scheduled for a procedure with anesthesia at Boston Children's Hospital
• Patients must have a diagnosis of Autism Spectrum Disorder (ASD) according to the DSM IV and DSM V (autism group) or an ASA score of I or II and no history of neurodevelopmental concerns (control group)

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Exclusion Criteria

-Families who are not able to read and speak English well enough to complete the validated surveys

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Observation	Patients with no developmental diagnoses
Autism Spectrum Disorder	Observation	Patients with a diagnosis of autism spectrum disorder

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative behavioral changes in the participants	up to two weeks following anesthesia

Trial Locations

Locations (1)

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