Clinical trial NCT04245306: Pilot Evaluation of a New Computerized Test for Pragmatic Inferences in Children with ASD
Official title: Pilot Evaluation of a New Computerized Test for Pragmatic Inferences in Children with Autism Spectrum Disorder Aged 8-12 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: pragmatic inferences
non-literal language
autism
attention-deficit
hyperactivity disorder
ADHD
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 232
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age between 8 and 12 years old
2. Native French speaker
3. Informed consent of the parents and children
4. \[For ASD group\] Diagnosis of ASD provided by a trained and entitled clinician
5. \[For DLD group\] Diagnosis of DLD provided by a trained and entitled clinician
6. \[For ASD and DLD groups\] IQ above 70
7. 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);
8. Medical diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) by a competent professional, confirmed by a parental assessment (ADHD-RS-IV)

Exclusion Criteria:

1. Uncorrected visual impairment
2. Uncorrected auditory impairment
3. Motor disability preventing the use of a touch pad
4. \[For the TD group\] Diagnosis of any neurodevelopmental or psychiatric condition
5. \[For ASD group\] Diagnosis of language disorder of attention disorder (ADHD)
6. \[For DLD group\] Diagnosis of ASD or ADHD
7. \[For ADHD group\] Diagnosis of ASD or DLD

Primary outcomes:
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.
timeFrame: One day
Secondary outcomes:
measure: 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
timeFrame: One day
measure: The TIPi composite score provides additional information compared to other cognitive assessments typically provided in the global assessment of children with ASD
timeFrame: One day
measure: 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.
timeFrame: One day
Other outcomes:
Locations:
city: Bron
country: France
facility: Ch Le Vinatier
Study officials:
References: