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Pilot Evaluation of a New Computerized Test for Pragmatic Inferences in Children With ASD (TIPI)

Primary Purpose

Autism Spectrum Disorder

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
computerized test for pragmatic inferences
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Autism Spectrum Disorder focused on measuring pragmatic inferences, non-literal language, autism

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

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

Sites / Locations

  • Ch Le VinatierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Children with Autism Spectrum Disorders

Typically Developing children

Children with Developmental Language Disorders

Arm Description

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

A larger group of 150 typically developing children (TD)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.

Full Information

First Posted
January 17, 2020
Last Updated
March 23, 2022
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT04245306
Brief Title
Pilot Evaluation of a New Computerized Test for Pragmatic Inferences in Children With ASD
Acronym
TIPI
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 7, 2020 (Actual)
Primary Completion Date
February 7, 2020 (Actual)
Study Completion Date
February 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 or another neurodevelopmental condition.
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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
pragmatic inferences, non-literal language, autism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 150 typically developing children (TD) A group of 25 children with developmental language disorders (DLD)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children with Autism Spectrum Disorders
Arm Type
Experimental
Arm Description
A group of 25 children with autism spectrum disorders (ASD)
Arm Title
Typically Developing children
Arm Type
Active Comparator
Arm Description
A larger group of 150 typically developing children (TD)
Arm Title
Children with Developmental Language Disorders
Arm Type
Experimental
Arm Description
A group of 25 children with developmental language disorders (DLD)
Intervention Type
Other
Intervention Name(s)
computerized test for pragmatic inferences
Intervention Description
Computerized tests
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
One day
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
One day
Title
The TIPi composite score provides additional information compared to other cognitive assessments typically provided in the global assessment of children with ASD
Description
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).
Time Frame
One day
Title
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.
Description
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.
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas PETIT
Phone
0437915256
Ext
+33
Email
nicolas.petit@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Lydie SARTELET
Phone
0437915531
Ext
+33
Email
lydie.sartelet@ch-le-vinatier.fr
Facility Information:
Facility Name
Ch Le Vinatier
City
Bron
ZIP/Postal Code
69678
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas PETIT
Phone
04 37 91 52 84
Ext
+33
Email
nicolas.petit@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Lydie SARTELET
Phone
0437915531
Ext
+33
Email
lydie.sartelet@ch-le-vinatier.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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