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

Autism Spectrum Disorder Clinical Trial

— TIPI  

Official title:

Pilot Evaluation of a New Computerized Test for Pragmatic Inferences in Children With Autism Spectrum Disorder Aged 8-12 Years Old

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04245306
• Other study ID #: 2019-A01721-56
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: February 7, 2023

Study information

• Verified date: July 2021
• Source: Hôpital le Vinatier
• Contact: Nicolas PETIT
• Phone: 0437915256
• Email: nicolas.petit[@]ch-le-vinatier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 or another neurodevelopmental condition.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 7, 2023
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• computerized test for pragmatic inferences
Computerized tests

Locations

Country	Name	City	State
France	Ch Le Vinatier	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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