Autism Spectrum DisorderNCT02818205
Electrodermal Patterns of Arousal in Children
An observational study of Autism Spectrum Disorder, run by Barpak Geriatric Health Services, Inc. d/b/a Barpak Occupational Therapy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 4 to 11 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Sensory Challenge Protocol
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- Men only
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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?
Read the 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).
- Conditions
- Autism Spectrum Disorder
- Being tested
- Sensory Challenge Protocol
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Challenge ProtocolOther
Measurement of electrodermal activity in response to sensation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Sensory Challenge Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrodermal Activity in response to sensation: tonic and phasic skin conductance in MicroSiemens
Measured: Within six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barpak Geriatric Health Services, Inc. d/b/a Barpak Occupational Therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818205
- Sponsor's protocol ID
- Barpak-02-EDA
- Status last verified
- Jun 2016
- First submitted
- 20 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 13527784MUNDY-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.
PubMed 13069662Schell 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.
PubMed 3241850Schoen 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.
PubMed 19915733Vetrugno 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.
PubMed 12955550
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrodermal Patterns of Arousal in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02818205
- Acronym / sponsor ID
- Barpak-02-EDA
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Barpak Geriatric Health Services, Inc. d/b/a Barpak Occupational TherapyUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Autism Spectrum Disorder | – | Other: Sensory Challenge ProtocolBoys 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 |
| Typically Developing Children | – | Other: Sensory Challenge ProtocolTypically 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. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory Challenge ProtocolMeasurement of electrodermal activity in response to sensation | Other | Children with Autism Spectrum Disorder, Typically Developing Children |
Primary outcome
Electrodermal Activity in response to sensation: tonic and phasic skin conductance in MicroSiemens
Time frame: Within six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Background: PubMed 13527784LACEY 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.
- Background: PubMed 13069662MUNDY-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.
- Background: PubMed 3241850Schell 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.
- Background: PubMed 19915733Schoen 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.
- Background: PubMed 12955550Vetrugno 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Barpak Geriatric Health Services, Inc. d/b/a Barpak Occupational Therapy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrodermal Activity in response to sensation: tonic and phasic skin conductance in MicroSiemens (time frame: Within six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02818205, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.