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CompletedNCT02646696Updated Jan 6, 2016

Reliability Study Using Electrodermal Activity to Measure Sensory Processing in Children With and Without Autism Spectrum Disorder

An observational study in Autism Spectrum Disorder, sponsored by Barpak Geriatric Health Services, Inc. d/b/a Barpak Occupational Therapy. Completed. Open to male participants aged 4 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-06.

Sponsored by Barpak Geriatric Health Services, Inc. d/b/a Barpak Occupational Therapy · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
32
Ages
4 Years to 11 Years
Sex
Male
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Study summary

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).

Read the 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.

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Conditions studied

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In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's enrollment of 32 is below the median of 102 across 267 observational studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Barpak Geriatric Health Services, Inc. d/b/a Barpak Occupational Therapy is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 11 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
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.

Eligibility criteria

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
32 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherSensory Challenge Protocol

    Measurement of electrodermal activity in response to sensation

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What researchers measure

Primary outcomes

  1. Electrodermal Activity in response to sensation

    Time frame: within six weeks

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 10503919 ↗
  • 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. PubMed 17436845 ↗
  • 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. PubMed 10208160 ↗
  • Schoen S, Miller LJ, Brett-Green B, Hepburn S. Psychophysiology of children with ASD. Research in Autism Spectrum Disorders 2: 417-429, 2008

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02646696
Lead sponsor
Barpak Geriatric Health Services, Inc. d/b/a Barpak Occupational Therapy
Responsible party
Sponsor
First posted
Jan 6, 2016
Start date
Jan 2013
Primary completion
Apr 2014
Completion
May 2014
Last update
Jan 6, 2016

Study contacts

Barbara M Schupak, PhD
principal investigator · Barpak GHS, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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