NCT01322984

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2011

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Last Updated

October 25, 2012

Status Verified

October 1, 2012

Enrollment Period

1.8 years

First QC Date

March 2, 2011

Last Update Submit

October 24, 2012

Conditions

Keywords

ASDStartle

Outcome Measures

Primary Outcomes (1)

  • 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.

    The startle reflex will be measured in relation to picture presentations during the experiment (e.g. day 1).

Study Arms (2)

Normal controls

ACTIVE COMPARATOR

Normal children and youths

Behavioral: PicturesBehavioral: Startle eliciting noise

ASD

EXPERIMENTAL

Children and youths diagnosed with autism spectrum disorder (ASD)

Behavioral: PicturesBehavioral: Startle eliciting noise

Interventions

PicturesBEHAVIORAL

The participants will be exposed to pictures of faces and non-facial stimuli presented on a PC screen.

ASDNormal controls

Startle will be elicited by 95 dB noise, presented at different times after picture onset.

ASDNormal controls

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosed with autism spectrum disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, University of Tromso

Tromsø, Troms, 9037, Norway

Location

Related Links

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Motion Pictures

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Audiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2011

First Posted

March 25, 2011

Study Start

March 1, 2011

Primary Completion

January 1, 2013

Last Updated

October 25, 2012

Record last verified: 2012-10

Locations