Clinical trial NCT02646696: Reliability Study Using Electrodermal Activity to Measure Sensory Processing in Children With and Without Autism Spectrum Disorder
Official title: Reliability of Electrodermal Activity: Quantifying Sensory Processing in Children With Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Lead sponsor: Barpak Geriatric Health Services, Inc. d/b/a Barpak Occupational Therapy
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 32
Sex: MALE
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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).

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.

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.

Primary outcomes:
measure: Electrodermal Activity in response to sensation
timeFrame: within six weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Barpak GHS, Inc.
name: Barbara M Schupak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Schoen S, Miller LJ, Brett-Green B, Hepburn S. Psychophysiology of children with ASD. Research in Autism Spectrum Disorders 2: 417-429, 2008