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

Autism Spectrum Disorder Clinical Trial

Official title:

Reliability of Electrodermal Activity: Quantifying Sensory Processing in Children With Autism Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646696
• Other study ID #: Barpak-01-EDA
• Status: Completed
• Phase: N/A
• First received: January 4, 2016
• Last updated: January 4, 2016
• Start date: January 2013
• Est. completion date: May 2014

Study information

• Verified date: January 2016
• Source: Barpak Geriatric Health Services, Inc. d/b/a Barpak Occupational Therapy
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 4 Years to 11 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Other:
• Sensory Challenge Protocol
Measurement of electrodermal activity in response to sensation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Barpak Geriatric Health Services, Inc. d/b/a Barpak Occupational Therapy

References & Publications (4)

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. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrodermal Activity in response to sensation		within six weeks	No