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

NCT02707939 | Unknown

• 1 other identifier: P00021473
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative behavioral changes in the participants

  up to two weeks following anesthesia

Study Arms (2)

Autism Spectrum Disorder

Patients with a diagnosis of autism spectrum disorder

Other: Observation

Controls

Patients with no developmental diagnoses

Other: Observation

Interventions

Observation OTHER

Patients will be observed before and after they receive anesthesia

Autism Spectrum Disorder; Controls

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants with an ASD diagnosis and control patients who do not have any history of neurodevelopmental concerns who are scheduled for a procedure under anesthesia at Boston Children's Hospital.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (3)

• Arnold B, Elliott A, Laohamroonvorapongse D, Hanna J, Norvell D, Koh J. Autistic children and anesthesia: is their perioperative experience different? Paediatr Anaesth. 2015 Nov;25(11):1103-10. doi: 10.1111/pan.12739. Epub 2015 Sep 4.

  PMID: 26338278 BACKGROUND

• Taghizadeh N, Davidson A, Williams K, Story D. Autism spectrum disorder (ASD) and its perioperative management. Paediatr Anaesth. 2015 Nov;25(11):1076-84. doi: 10.1111/pan.12732. Epub 2015 Aug 6.

  PMID: 26248302 BACKGROUND

• van der Walt JH, Moran C. An audit of perioperative management of autistic children. Paediatr Anaesth. 2001 Jul;11(4):401-8. doi: 10.1046/j.1460-9592.2001.00688.x.

  PMID: 11442855 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Observation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Bistra Vlassakova, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Halpin, MSN, RN

CONTACT

857-218-4585; erin.halpin@childrens.harvard.edu

Rachel Bernier, MPH

CONTACT

8572185348; rachel.bernier@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 14, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)