- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02818205
Electrodermal Patterns of Arousal in Children
June 27, 2016 updated by: Barpak Geriatric Health Services, Inc. d/b/a Barpak Occupational Therapy
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
Conditions
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.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
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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