Autism Spectrum DisorderTIPINCT04245306
Pilot Evaluation of a New Computerized Test for Pragmatic Inferences in Children with ASD
A study testing computerized test for pragmatic inferences in people with Autism Spectrum Disorder, run by Hôpital le Vinatier at 1 site in France.
Trial summary
This study aims to evaluate the relevance of a new computerized test for pragmatic inferences (TIPi) in children aged 8 to 12 YO, presenting a typical development, autism spectrum disorders, another neurodevelopmental condition and attention-deficit/hyperactivity disorder. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- computerized test for pragmatic inferences
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2020to 4 May 2023
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 8 and 12 years old
- Native French speaker
- Informed consent of the parents and children
- [For ASD group] Diagnosis of ASD provided by a trained and entitled clinician
- [For DLD group] Diagnosis of DLD provided by a trained and entitled clinician
- [For ASD and DLD groups] IQ above 70
- Intellectual efficiency within the norm (ITQ > 70), confirmed by objective results (psychometrics) in the participant's file, or collected if necessary within the framework of this study (using the WISC V);
- Medical diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) by a competent professional, confirmed by a parental assessment (ADHD-RS-IV)
Who cannot join
- Uncorrected visual impairment
- Uncorrected auditory impairment
- Motor disability preventing the use of a touch pad
- [For the TD group] Diagnosis of any neurodevelopmental or psychiatric condition
- [For ASD group] Diagnosis of language disorder of attention disorder (ADHD)
- [For DLD group] Diagnosis of ASD or ADHD
- [For ADHD group] Diagnosis of ASD or DLD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Evaluation of a New Computerized Test for Pragmatic Inferences in Children with Autism Spectrum Disorder Aged 8-12 Years Old
This study aims to evaluate the relevance of a new computerized test for pragmatic inferences (TIPi) in children aged 8 to 12 YO, presenting a typical development, autism spectrum disorders, another neurodevelopmental condition and attention-deficit/hyperactivity disorder.
Read the detailed description
By virtue of pragmatic inference-making, a listener can go above and beyond the linguistic meaning of the speaker's utterance in order to understand what the speaker intended to communicate. Such inferences allow the listener to understand inter alia irony, metaphor, indirect requests, scalar and ad-hoc implicatures. Autistic individuals have typically been described, by clinicians and language specialists, as tending towards having a literal understanding of language and as being deficient with respect to understanding a speaker's intended meaning, and these difficulties have a major impact on quality of life and social participation. Therefore, assessing these abilities seems essential, both for diagnosis purpose and to draw a clear description of an individual's functioning profile. Yet, no tool is available for children aged 8 to 12 in French. A new test named TIPi has been developed to resolve this issue. This new test is computerized and runs in a touch pad. The main goal of the present study is to evaluate the ability of the TIPi to discriminate autism spectrum disorders (ASD), attention-deficit/hyperactivity disorder (ADHD) children from typically developing (TD) children. Secondary goals are (i) to measure the typical development of these abilities in TD children in this age range, (ii) to assess the developmental link these skills might have with other cognitive of language abilities (mentalizing, cognitive flexibility, core language skills, central coherence), and (iii) to compare the pragmatic profile of ASD children with another neurodevelopmental condition: developmental language disorder, in order to test the relevance of this test for differential diagnosis.
- Conditions
- Autism Spectrum Disorder
- Being tested
- computerized test for pragmatic inferences
- Keywords
- pragmatic inferences, non-literal language, autism, attention-deficit, hyperactivity disorder, ADHD
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized test for pragmatic inferencesOther
Computerized tests
| Study group | Role | What they receive |
|---|---|---|
| Children with Autism Spectrum Disorders | Experimental | A group of 25 children with autism spectrum disorders (ASD) Receives: Other: computerized test for pragmatic inferences |
| Typically Developing children | Active comparator | A larger group of 150 typically developing children (TD) Receives: Other: computerized test for pragmatic inferences |
| Children with Developmental Language Disorders | Experimental | A group of 25 children with developmental language disorders (DLD) Receives: Other: computerized test for pragmatic inferences |
| children with attention-deficit/hyperactivity disorder (ADHD group) | Experimental | 25 children with attention-deficit/hyperactivity disorder (ADHD group) Receives: Other: computerized test for pragmatic inferences |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discrimination power of the measure assessed by the dissociation of the developmental trajectories of children with ASD compared to TD children in the composite score of the TIPi.
The dissociation between the developmental trajectories of these two groups will be assessed by comparing the coefficients of the linear regressions linking performance in the TIPi (composite score) and chronological age in these two groups.
Measured: One day
Secondary outcomes (3)
Sensitivity of the TIPi composite score (measuring pragmatic inferencing) to typical development in the targeted age range: 8 to 12 years oldin the targeted age range: 8 to 12 years old
Sensitivity to age of the TIPi composite score is assessed by the alpha coefficient of the regression analysis linking the composite score to chronological age in the TD group.
Measured: One day
The TIPi composite score provides additional information compared to other cognitive assessments typically provided in the global assessment of children with ASD
The predictive power of the best fitted multiple regression model explaining this measure by - jointly - performances in language task, mentalizing task, cognitive flexibility task, central coherence task and age (this predictive power being measured by the adjusted R2 of the model).
Measured: One day
Discrimination power of the measure assessed by the dissociation of the developmental trajectories of children with ASD compared to children with DLD in the composite score of the TIPi.
The dissociation between the developmental trajectories of these two groups will be assessed by comparing the coefficients of the linear regressions linking performance in the TIPi (composite score) and chronological age in these two groups.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start7 Feb 2020
- Primary completion7 Feb 2020
- Study completion4 May 2023
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.
- More trials run by Hôpital le VinatierThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Three groups of children are included to be compared, in order to test the primary and secondary hypothesis of this study : * A group of 25 children with autism spectrum disorders (ASD) * A larger group of 190 typically developing children (TD) * A group of 25 children with developmental language disorders (DLD) * A group of 25 children with attention-deficit/hyperactivity disorder (ADHD group)
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245306
- Sponsor's protocol ID
- 2019-A01721-56
- Acronym
- TIPI
- Status last verified
- Nov 2023
- First submitted
- 17 Jan 2020
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of a New Computerized Test for Pragmatic Inferences in Children with Autism Spectrum Disorder Aged 8-12 Years Old
- ClinicalTrials.gov ID
- NCT04245306
- Acronym / sponsor ID
- TIPI / 2019-A01721-56
- Conditions
- Autism Spectrum Disorder
- Keywords
- pragmatic inferences, non-literal language, autism, attention-deficit, hyperactivity disorder, ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 28 Jan 2020 (actual)
- 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.
This study aims to evaluate the relevance of a new computerized test for pragmatic inferences (TIPi) in children aged 8 to 12 YO, presenting a typical development, autism spectrum disorders, another neurodevelopmental condition and attention-deficit/hyperactivity disorder.
Detailed description
By virtue of pragmatic inference-making, a listener can go above and beyond the linguistic meaning of the speaker's utterance in order to understand what the speaker intended to communicate. Such inferences allow the listener to understand inter alia irony, metaphor, indirect requests, scalar and ad-hoc implicatures. Autistic individuals have typically been described, by clinicians and language specialists, as tending towards having a literal understanding of language and as being deficient with respect to understanding a speaker's intended meaning, and these difficulties have a major impact on quality of life and social participation. Therefore, assessing these abilities seems essential, both for diagnosis purpose and to draw a clear description of an individual's functioning profile. Yet, no tool is available for children aged 8 to 12 in French. A new test named TIPi has been developed to resolve this issue. This new test is computerized and runs in a touch pad. The main goal of the present study is to evaluate the ability of the TIPi to discriminate autism spectrum disorders (ASD), attention-deficit/hyperactivity disorder (ADHD) children from typically developing (TD) children. Secondary goals are (i) to measure the typical development of these abilities in TD children in this age range, (ii) to assess the developmental link these skills might have with other cognitive of language abilities (mentalizing, cognitive flexibility, core language skills, central coherence), and (iii) to compare the pragmatic profile of ASD children with another neurodevelopmental condition: developmental language disorder, in order to test the relevance of this test for differential diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Three groups of children are included to be compared, in order to test the primary and secondary hypothesis of this study : * A group of 25 children with autism spectrum disorders (ASD) * A larger group of 190 typically developing children (TD) * A group of 25 children with developmental language disorders (DLD) * A group of 25 children with attention-deficit/hyperactivity disorder (ADHD group)
| Arm | Type | Receives |
|---|---|---|
| Children with Autism Spectrum Disorders | Experimental | Other: computerized test for pragmatic inferencesA group of 25 children with autism spectrum disorders (ASD) |
| Typically Developing children | Active comparator | Other: computerized test for pragmatic inferencesA larger group of 150 typically developing children (TD) |
| Children with Developmental Language Disorders | Experimental | Other: computerized test for pragmatic inferencesA group of 25 children with developmental language disorders (DLD) |
| children with attention-deficit/hyperactivity disorder (ADHD group) | Experimental | Other: computerized test for pragmatic inferences25 children with attention-deficit/hyperactivity disorder (ADHD group) |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age between 8 and 12 years old
- Native French speaker
- Informed consent of the parents and children
- [For ASD group] Diagnosis of ASD provided by a trained and entitled clinician
- [For DLD group] Diagnosis of DLD provided by a trained and entitled clinician
Key exclusion criteria (7 listed)
- Uncorrected visual impairment
- Uncorrected auditory impairment
- Motor disability preventing the use of a touch pad
- [For the TD group] Diagnosis of any neurodevelopmental or psychiatric condition
- [For ASD group] Diagnosis of language disorder of attention disorder (ADHD)
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 |
|---|---|---|
| computerized test for pragmatic inferencesComputerized tests | Other | Children with Autism Spectrum Disorders, Children with Developmental Language Disorders, Typically Developing children, children with attention-deficit/hyperactivity disorder (ADHD group) |
Primary outcome
Discrimination power of the measure assessed by the dissociation of the developmental trajectories of children with ASD compared to TD children in the composite score of the TIPi.
Time frame: One day
The dissociation between the developmental trajectories of these two groups will be assessed by comparing the coefficients of the linear regressions linking performance in the TIPi (composite score) and chronological age in these two groups.
3 secondary outcomes
Sensitivity of the TIPi composite score (measuring pragmatic inferencing) to typical development in the targeted age range: 8 to 12 years oldin the targeted age range: 8 to 12 years old
Time frame: One day
The TIPi composite score provides additional information compared to other cognitive assessments typically provided in the global assessment of children with ASD
Time frame: One day
Discrimination power of the measure assessed by the dissociation of the developmental trajectories of children with ASD compared to children with DLD in the composite score of the TIPi.
Time frame: One day
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 28 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computerized test for pragmatic inferences in people with Autism Spectrum Disorder, run by Hôpital le Vinatier at 1 site in France.
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 8 inclusion and 7 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 28 Oct 2024. 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 France. 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?
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?
Discrimination power of the measure assessed by the dissociation of the developmental trajectories of children with ASD compared to TD children in the composite score of the TIPi. (time frame: One day). 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 28 Oct 2024.