Cognitive and Emotional Processing of Social Stimuli in Children and Youth With Autism Spectrum Disorder
Primary Purpose
Autism Spectrum Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Pictures
Startle eliciting noise
Sponsored by
About this trial
This is an interventional basic science trial for Autism Spectrum Disorder focused on measuring ASD, Startle
Eligibility Criteria
For ASD group:
Inclusion Criteria:
- Diagnosed with autism spectrum disorders
Sites / Locations
- Department of Psychology, University of Tromso
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Normal controls
ASD
Arm Description
Normal children and youths
Children and youths diagnosed with autism spectrum disorder (ASD)
Outcomes
Primary Outcome Measures
The eyeblink of the Startle reflex is measured.
The startle reflex is potentiated when participants are influenced by negative emotions. Accordingly, startle will be measured in relation to picture presentation to gauge the emotional effect of the pictures. It is expected that the ASD group will show fear potentiated startle to pictures of human faces.
Secondary Outcome Measures
Full Information
NCT ID
NCT01322984
First Posted
March 2, 2011
Last Updated
October 24, 2012
Sponsor
University of Tromso
Collaborators
The Royal Norwegian Ministry of Health
1. Study Identification
Unique Protocol Identification Number
NCT01322984
Brief Title
Cognitive and Emotional Processing of Social Stimuli in Children and Youth With Autism Spectrum Disorder
Official Title
Cognitive and Emotional Processing of Social Stimuli in Children and Youth With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tromso
Collaborators
The Royal Norwegian Ministry of Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Children and youth diagnosed with autism spectrum disorder (ASD) have been shown to react abnormally to social stimuli, especially to human faces. Children and youth with ASD show less interest in social stimuli, and may even avoid looking at or interact with such stimuli. It has been proposed that social stimuli elicit reactions like fear and stress in individuals with ASD, and this explains the lack of interest and avoidance. The present project investigates this hypothesis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
ASD, Startle
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal controls
Arm Type
Active Comparator
Arm Description
Normal children and youths
Arm Title
ASD
Arm Type
Experimental
Arm Description
Children and youths diagnosed with autism spectrum disorder (ASD)
Intervention Type
Behavioral
Intervention Name(s)
Pictures
Intervention Description
The participants will be exposed to pictures of faces and non-facial stimuli presented on a PC screen.
Intervention Type
Behavioral
Intervention Name(s)
Startle eliciting noise
Intervention Description
Startle will be elicited by 95 dB noise, presented at different times after picture onset.
Primary Outcome Measure Information:
Title
The eyeblink of the Startle reflex is measured.
Description
The startle reflex is potentiated when participants are influenced by negative emotions. Accordingly, startle will be measured in relation to picture presentation to gauge the emotional effect of the pictures. It is expected that the ASD group will show fear potentiated startle to pictures of human faces.
Time Frame
The startle reflex will be measured in relation to picture presentations during the experiment (e.g. day 1).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
For ASD group:
Inclusion Criteria:
Diagnosed with autism spectrum disorders
Facility Information:
Facility Name
Department of Psychology, University of Tromso
City
Tromso
State/Province
Troms
ZIP/Postal Code
9037
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ole Åsli, PhD
Phone
77646778
Email
ole.asli@uit.no
First Name & Middle Initial & Last Name & Degree
Ole Åsli, PhD
12. IPD Sharing Statement
Links:
URL
http://uit.no
Description
Related Info
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Cognitive and Emotional Processing of Social Stimuli in Children and Youth With Autism Spectrum Disorder
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