NCT02818205

Brief Summary

The purpose of this study was to explore the feasibility of detecting physiological patterns of arousal to sensory inputs in children with and without Autism Spectrum Disorder (ASD). Accordingly, two questions directed this methodological research investigation: (1) Is there a relationship between rest (tonic) and response (phasic) patterns of arousal among typically developing children and children with ASD?, and (2) Is there a difference in EDA response to sensation between typically developing children and children with ASD?

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

1.2 years

First QC Date

June 20, 2016

Last Update Submit

June 27, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Electrodermal Activity in response to sensation: tonic and phasic skin conductance in MicroSiemens

    Within six weeks

Study Arms (2)

Children with Autism Spectrum Disorder

Boys between the age of 4 to 11 years old with Autism Spectrum disorder will participate in the Sensory Challenge Protocol which will measure electrodermal activity in response to sensation

Other: Sensory Challenge Protocol

Typically Developing Children

Typically developing boys between the age of 4 to 11 years will participate in the Sensory Challenge Protocol which will measure electrodermal activity in response to sensation.

Other: Sensory Challenge Protocol

Interventions

Measurement of electrodermal activity in response to sensation

Children with Autism Spectrum DisorderTypically Developing Children

Eligibility Criteria

Age4 Years - 11 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

A convenience sample of boys between the ages of 4 - 11 years with and without a diagnosis of Autism Spectrum Disorder were recruited from private and public New Jersey Schools, Barpak Occupational Therapy clinic, Bergenfield, New Jersey and Seton Hall University campus.

You may qualify if:

  • Able to sit for 30 minutes and follow simple directions.
  • Children with confirmed Autism Spectrum Disorder via School records or parent report.
  • Typically developing children free of medical or neurological conditions.

You may not qualify if:

  • Medical or neurological conditions other than Autism.
  • Hearing loss or visual impairments.
  • Children taking medications known to affect arousal.
  • Children who are not able to follow simple commands.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • LACEY JI, LACEY BC. The relationship of resting autonomic activity to motor impulsivity. Res Publ Assoc Res Nerv Ment Dis. 1958;36:144-209. No abstract available.

    PMID: 13527784BACKGROUND
  • MUNDY-CASTLE AC, MCKIEVER BL. The psychophysiological significance of the galvanic skin response. J Exp Psychol. 1953 Jul;46(1):15-24. doi: 10.1037/h0060100. No abstract available.

    PMID: 13069662BACKGROUND
  • Schell AM, Dawson ME, Filion DL. Psychophysiological correlates of electrodermal lability. Psychophysiology. 1988 Nov;25(6):619-32. doi: 10.1111/j.1469-8986.1988.tb01899.x. No abstract available.

    PMID: 3241850BACKGROUND
  • Schoen SA, Miller LJ, Brett-Green BA, Nielsen DM. Physiological and behavioral differences in sensory processing: a comparison of children with autism spectrum disorder and sensory modulation disorder. Front Integr Neurosci. 2009 Nov 3;3:29. doi: 10.3389/neuro.07.029.2009. eCollection 2009.

    PMID: 19915733BACKGROUND
  • Vetrugno R, Liguori R, Cortelli P, Montagna P. Sympathetic skin response: basic mechanisms and clinical applications. Clin Auton Res. 2003 Aug;13(4):256-70. doi: 10.1007/s10286-003-0107-5.

    PMID: 12955550BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 29, 2016

Study Start

January 1, 2013

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

June 29, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share