- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02646696
Reliability Study Using Electrodermal Activity to Measure Sensory Processing in Children With and Without Autism Spectrum Disorder
January 4, 2016 updated by: Barpak Geriatric Health Services, Inc. d/b/a Barpak Occupational Therapy
Reliability of Electrodermal Activity: Quantifying Sensory Processing in Children With Autism Spectrum Disorder
The purpose of this study is tTho establish test-retest reliability of electrodermal markers used to quantify physiologic response to sensation using the Sensory Challenge Protocol in children with and without Autism Spectrum Disorder (ASD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This methodological research design is a prospective exploratory test-retest design assessing the use of electrodermal activity (EDA) as an index of sensory processing.
EDA will be measured using skin conductance response (SCR).
The purpose of this study is to investigate if using EDA is a reliable measure over time within the context of response to sensation.
Scores from test one and test two of each subject will be correlated to determine reliability of EDA measure.
Reliability in this context will establish the utility of EDA as an index of sensory processing.
Testing will occur two times within a six week period.
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
Yes
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
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
Time Frame: within six weeks
|
within six weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Barbara M Schupak, PhD, Barpak GHS, Inc.
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
- Miller LJ, McIntosh DN, McGrath J, Shyu V, Lampe M, Taylor AK, Tassone F, Neitzel K, Stackhouse T, Hagerman RJ. Electrodermal responses to sensory stimuli in individuals with fragile X syndrome: a preliminary report. Am J Med Genet. 1999 Apr 2;83(4):268-79.
- McIntosh DN, Miller LJ, Shyu V, Hagerman RJ. Sensory-modulation disruption, electrodermal responses, and functional behaviors. Dev Med Child Neurol. 1999 Sep;41(9):608-15. doi: 10.1017/s0012162299001267.
- Miller LJ, Coll JR, Schoen SA. A randomized controlled pilot study of the effectiveness of occupational therapy for children with sensory modulation disorder. Am J Occup Ther. 2007 Mar-Apr;61(2):228-38. doi: 10.5014/ajot.61.2.228.
- Schoen S, Miller LJ, Brett-Green B, Hepburn S. Psychophysiology of children with ASD. Research in Autism Spectrum Disorders 2: 417-429, 2008
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
January 4, 2016
First Submitted That Met QC Criteria
January 4, 2016
First Posted (Estimate)
January 6, 2016
Study Record Updates
Last Update Posted (Estimate)
January 6, 2016
Last Update Submitted That Met QC Criteria
January 4, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Barpak-01-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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