AutismNCT02579109
Multisensorial Information's Treatment in Autism Spectrum Disorder
A study testing memory test in people with Autism, run by Centre Hospitalier Universitaire de Nice.
Trial summary
Introduction: Autism spectrum disorder is characterized by deficits in three functional domains: language and communication, social reciprocity, and the presence of restricted interests/repetitive behaviors. There's also deficits in social cognition. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- memory test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Aug 2014
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Boy or girl,
- 7 - 13 years,
- Presenting a diagnosis DSM IV of disorder(confusion) of the autistic spectre: detected by the scale(ladder) ADI ( Autism Diagnostic Interview) or by TEENAGERS (Autism Diagnostic Observation Schedule): typical autistic. These patients do not answer the diagnosis of psychosis according to Kiddie-SADS,
- Upper total IQ or equal to 50, examination dating less than year before the inclusion,
- French-speaking children,
- Signature of the informed consent by the parents(relatives) and the child,
- Membership to the Social Security.
Who cannot join
- Genetic, neurological or neurosensory pathologies,
- Diagnosis of intrusive disorder(confusion) of the not specified development: TED our,
- The patients will not be included who would participate in a program or a study of reeducation in the social fitnesses.
About this study
Official title: Exploring Social Cognition in Autism Spectrum Disorder With Long Time Memory Task. Controlled Study on 8-13 Years Childs
Introduction:
Autism spectrum disorder is characterized by deficits in three functional domains: language and communication, social reciprocity, and the presence of restricted interests/repetitive behaviors. There's also deficits in social cognition. When having a face-to-face conversation, a listener not only hears what a speaker is saying, but also sees the articulatory gestures that accompany those sounds. Speech signals needs then a multisensory processing. Impairments in multisensory perceptual binding may be particularly relevant in ASD, given that hallmark features of the disorder include difficulties in speech, communication, and social interactions.
Read more
Objectives:
The investigator suggest that atypical multisensory processing in ASD may have an impact on speech perception and social processing.
Aims:
Methods:
This pilot study measures free recall scores in 3 lists of words presentation after 30 minutes. In the first condition (CI) words are only listening. In the second condition (CII) words are associated with a picture of a mans face. In the third condition (CIII) words are associated with a video of a man speaking. Three lists are homogeneous form words characteristics (lexical frequency, emotional valence norm, imageability). Participants were 7- to 13-year-olds typically developing children (TD) (N = 19) and ASD children (N = 19).
The investigator would create some new tools for exploring the treatment of a social information. These tools should be the closest of a ecological social interaction.
- Conditions
- Autism
- Being tested
- memory test
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
memory testOther
| Study group | Role | What they receive |
|---|---|---|
| autistic patient | Other | patient with autistic trouble Receives: Other: memory test |
| healthy volunteers | Other | healthy volunteers Receives: Other: memory test |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of reminder after 30 minutes between the group autistic and the group witness( %)
Comparison between the group autistic and the group witness of the difference enter the rate of reminder(abseiling) in 30 minutes of the words proposed in video and audio sequences.
Measured: 30 minutes
Secondary outcomes (1)
Difference of the scores of reminders words (%)
Difference of the scores of reminders between the both group, immediately after procedure and 30 minutes after procedure
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startFeb 2014
- Primary completionFeb 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579109
- Sponsor's protocol ID
- 13AOI09
- Status last verified
- Oct 2015
- First submitted
- 29 Sep 2015
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Social Cognition in Autism Spectrum Disorder With Long Time Memory Task. Controlled Study on 8-13 Years Childs
- ClinicalTrials.gov ID
- NCT02579109
- Acronym / sponsor ID
- 13AOI09
- Conditions
- Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 19 Oct 2015 (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.
Introduction:
Autism spectrum disorder is characterized by deficits in three functional domains: language and communication, social reciprocity, and the presence of restricted interests/repetitive behaviors. There's also deficits in social cognition. When having a face-to-face conversation, a listener not only hears what a speaker is saying, but also sees the articulatory gestures that accompany those sounds. Speech signals needs then a multisensory processing. Impairments in multisensory perceptual binding may be particularly relevant in ASD, given that hallmark features of the disorder include difficulties in speech, communication, and social interactions.
Objectives:
The investigator suggest that atypical multisensory processing in ASD may have an impact on speech perception and social processing.
Aims:
Methods:
This pilot study measures free recall scores in 3 lists of words presentation after 30 minutes. In the first condition (CI) words are only listening. In the second condition (CII) words are associated with a picture of a mans face. In the third condition (CIII) words are associated with a video of a man speaking. Three lists are homogeneous form words characteristics (lexical frequency, emotional valence norm, imageability). Participants were 7- to 13-year-olds typically developing children (TD) (N = 19) and ASD children (N = 19).
The investigator would create some new tools for exploring the treatment of a social information. These tools should be the closest of a ecological social interaction.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autistic patient | Other | Other: memory testpatient with autistic trouble |
| healthy volunteers | Other | Other: memory testhealthy volunteers |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Boy or girl,
- 7 - 13 years,
- Presenting a diagnosis DSM IV of disorder(confusion) of the autistic spectre: detected by the scale(ladder) ADI ( Autism Diagnostic Interview) or by TEENAGERS (Autism Diagnostic Observation Schedule): typical autistic. These patients do not answer the diagnosis of psychosis according to Kiddie-SADS,
- Upper total IQ or equal to 50, examination dating less than year before the inclusion,
- French-speaking children,
Key exclusion criteria (3 listed)
- Genetic, neurological or neurosensory pathologies,
- Diagnosis of intrusive disorder(confusion) of the not specified development: TED our,
- The patients will not be included who would participate in a program or a study of reeducation in the social fitnesses.
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 |
|---|---|---|
| memory test | Other | autistic patient, healthy volunteers |
Primary outcome
rate of reminder after 30 minutes between the group autistic and the group witness( %)
Time frame: 30 minutes
Comparison between the group autistic and the group witness of the difference enter the rate of reminder(abseiling) in 30 minutes of the words proposed in video and audio sequences.
1 secondary outcome
Difference of the scores of reminders words (%)
Time frame: 30 minutes
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 19 Oct 2015.
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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?
A study testing memory test in people with Autism, run by Centre Hospitalier Universitaire de Nice.
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 7 inclusion and 3 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 19 Oct 2015. 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?
rate of reminder after 30 minutes between the group autistic and the group witness( %) (time frame: 30 minutes). 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 19 Oct 2015.