Pilot Evaluation of a New Computerized Test for Pragmatic Inferences in Children with ASD

NCT ID: NCT04245306

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-07

Study Completion Date

2023-05-04

Brief Summary

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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

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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

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Autism Spectrum Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Children with Autism Spectrum Disorders

A group of 25 children with autism spectrum disorders (ASD)

Group Type EXPERIMENTAL

computerized test for pragmatic inferences

Intervention Type OTHER

Computerized tests

Typically Developing children

A larger group of 150 typically developing children (TD)

Group Type ACTIVE_COMPARATOR

computerized test for pragmatic inferences

Intervention Type OTHER

Computerized tests

Children with Developmental Language Disorders

A group of 25 children with developmental language disorders (DLD)

Group Type EXPERIMENTAL

computerized test for pragmatic inferences

Intervention Type OTHER

Computerized tests

children with attention-deficit/hyperactivity disorder (ADHD group)

25 children with attention-deficit/hyperactivity disorder (ADHD group)

Group Type EXPERIMENTAL

computerized test for pragmatic inferences

Intervention Type OTHER

Computerized tests

Interventions

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computerized test for pragmatic inferences

Computerized tests

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ch Le Vinatier

Bron, , France

Site Status

Countries

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France

Other Identifiers

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2019-A01721-56

Identifier Type: -

Identifier Source: org_study_id

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