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

Sponsor
Boston Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02707939
Collaborator
(none)
200
1
82
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Observation

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Prospective Study on Behavioral Outcomes of Children With Autism Spectrum Disorder (ASD) in Comparison to Those Without Neurodevelopmental Diagnoses
Study Start Date :
Feb 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Autism Spectrum Disorder

Patients with a diagnosis of autism spectrum disorder

Other: Observation
Patients will be observed before and after they receive anesthesia

Controls

Patients with no developmental diagnoses

Other: Observation
Patients will be observed before and after they receive anesthesia

Outcome Measures

Primary Outcome Measures

  1. Incidence of postoperative behavioral changes in the participants [up to two weeks following anesthesia]

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Exclusion Criteria:

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston Children's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Boston Children's Hospital

Investigators

  • Principal Investigator: Bistra Vlassakova, MD, Boston Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bistra Vlassakova, MD, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT02707939
Other Study ID Numbers:
  • P00021473
First Posted:
Mar 14, 2016
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2022