Autism Spectrum DisorderNCT01322984
Cognitive and Emotional Processing of Social Stimuli in Children and Youth With Autism Spectrum Disorder
A study testing Pictures and Startle eliciting noise in people with Autism Spectrum Disorder, run by University of Tromso at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Pictures and Startle eliciting noise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2011to Jan 2013
- Phase
- Interventional
- 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 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosed with autism spectrum disorders
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Psychology, University of Tromso
Tromsø, Troms, 9037
Ole Åsli, PhD, 77646778, ole.asli@uit.no
Ole Åsli, PhD
About this study
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Pictures, Startle eliciting noise
- Keywords
- ASD, Startle
- 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.
PicturesBehavioural
The participants will be exposed to pictures of faces and non-facial stimuli presented on a PC screen.
Startle eliciting noiseBehavioural
Startle will be elicited by 95 dB noise, presented at different times after picture onset.
| Study group | Role | What they receive |
|---|---|---|
| Normal controls | Active comparator | Normal children and youths Receives: Behavioral: Pictures; Behavioral: Startle eliciting noise |
| ASD | Experimental | Children and youths diagnosed with autism spectrum disorder (ASD) Receives: Behavioral: Pictures; Behavioral: Startle eliciting noise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The startle reflex will be measured in relation to picture presentations during the experiment (e.g. day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322984
- Sponsor's protocol ID
- 2010/238
- Status last verified
- Oct 2012
- First submitted
- 2 Mar 2011
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Emotional Processing of Social Stimuli in Children and Youth With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT01322984
- Acronym / sponsor ID
- 2010/238
- Conditions
- Autism Spectrum Disorder
- Keywords
- ASD, Startle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Study start
- Mar 2011
- Primary completion
- Jan 2013 (estimated)
- First posted
- 25 Mar 2011 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal controls | Active comparator | Behavioral: Pictures, Behavioral: Startle eliciting noiseNormal children and youths |
| ASD | Experimental | Behavioral: Pictures, Behavioral: Startle eliciting noiseChildren and youths diagnosed with autism spectrum disorder (ASD) |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Diagnosed with autism spectrum disorders
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PicturesThe participants will be exposed to pictures of faces and non-facial stimuli presented on a PC screen. | Behavioural | ASD, Normal controls |
| Startle eliciting noiseStartle will be elicited by 95 dB noise, presented at different times after picture onset. | Behavioural | ASD, Normal controls |
Primary outcome
The eyeblink of the Startle reflex is measured.
Time frame: The startle reflex will be measured in relation to picture presentations during the experiment (e.g. day 1).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
- Related InfoLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pictures and Startle eliciting noise in people with Autism Spectrum Disorder, run by University of Tromso at 1 site in Norway.
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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The eyeblink of the Startle reflex is measured. (time frame: The startle reflex will be measured in relation to picture presentations during the experiment (e.g. day 1).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2012.