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

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 or another neurodevelopmental condition.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: computerized test for pragmatic inferences

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas PETIT; Phone Number: +33 0437915256; Email: nicolas.petit@ch-le-vinatier.fr

Study Locations

• France
  • Bron, France, 69678
    • Recruiting
    • CH Le Vinatier
    • Contact: Nicolas PETIT; Phone Number: +33 04 37 91 52 84; Email: nicolas.petit@ch-le-vinatier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Children with Autism Spectrum Disorders; A group of 25 children with autism spectrum disorders (ASD)	Other: computerized test for pragmatic inferences; Computerized tests
Active Comparator: Typically Developing children; A larger group of 150 typically developing children (TD)	Other: computerized test for pragmatic inferences; Computerized tests
Experimental: Children with Developmental Language Disorders; A group of 25 children with developmental language disorders (DLD)	Other: computerized test for pragmatic inferences; Computerized tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	One day

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2020
• Primary Completion (Actual): February 7, 2020
• Study Completion (Anticipated): February 7, 2023

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: autism; pragmatic inferences; non-literal language
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: 2019-A01721-56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No