Electrodermal Patterns of Arousal in Children

Electrodermal Patterns of Arousal in Children With Autism Spectrum Disorder

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?

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

This methodological research design is a prospective exploratory test-retest design assessing the relationship between tonic and phasic Electrodermal Activity (EDA) variables. EDA during rest and in response to a variety of sensations was measured using skin conductance. Descriptive statistics summarized EDA dependent variable data using skin conductance response (SCR) magnitude, SCR amplitude, skin conductance level (SCL), non-specific response (NSR) and habituation (HAB). The data was used to assess the relationship between tonic and phasic patterns of arousal and compare response patterns between groups using the Sensory Challenge Protocol (SCP) in children with ASD and typically developing children (TD).

Study Type

Observational

Enrollment (Actual)

32

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-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.

Description

Inclusion Criteria: Boys ages 4 - 11 years old.

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Measurement of electrodermal activity in response to sensation
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.
Measurement of electrodermal activity in response to sensation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Electrodermal Activity in response to sensation: tonic and phasic skin conductance in MicroSiemens
Time Frame: Within six weeks
Within six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Barpak-02-EDA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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