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Completed

NCT Number: NCT04245306

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

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ch Le Vinatier

Bron, 69678, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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);
  • Medical diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) by a competent professional, confirmed by a parental assessment (ADHD-RS-IV)

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
  • [For ADHD group] Diagnosis of ASD or DLD

Treatment and study plan

computerized test for pragmatic inferences

Other

Computerized tests

Primary outcomes

  1. 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.

    Time frame: One day

    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 outcomes

  1. 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

    Time frame: One day

    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.

  2. The TIPi composite score provides additional information compared to other cognitive assessments typically provided in the global assessment of children with ASD

    Time frame: One day

    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).

  3. 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.

    Time frame: One day

    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.

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

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

Acronym: TIPI

Important dates

Study start
2020
Primary completion
2020
Study completion
2023
First posted
Jan 28, 2020
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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