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

October 24, 2024 updated by: Hôpital le Vinatier

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, another neurodevelopmental condition and attention-deficit/hyperactivity disorder.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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), 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
232

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Bron, France, 69678
        • Ch Le Vinatier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

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
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Experimental: children with attention-deficit/hyperactivity disorder (ADHD group)
25 children with attention-deficit/hyperactivity disorder (ADHD group)
Other: computerized test for pragmatic inferences
Computerized tests

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
One day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.
One day
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).
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.
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.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hôpital le Vinatier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 7, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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