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

NCT04245306 | Completed DMC

• 1 other identifier: 2019-A01721-56
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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

Conditions

Autism Spectrum Disorder

Keywords

pragmatic inferences; non-literal language; autism; attention-deficit; hyperactivity disorder; ADHD

Outcome Measures

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.

  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 Outcomes (3)

• 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

  One day

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

  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.

  One day

Study Arms (4)

Children with Autism Spectrum Disorders

EXPERIMENTAL

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

Other: computerized test for pragmatic inferences

Typically Developing children

ACTIVE COMPARATOR

A larger group of 150 typically developing children (TD)

Other: computerized test for pragmatic inferences

Children with Developmental Language Disorders

EXPERIMENTAL

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

Other: computerized test for pragmatic inferences

children with attention-deficit/hyperactivity disorder (ADHD group)

EXPERIMENTAL

25 children with attention-deficit/hyperactivity disorder (ADHD group)

Other: computerized test for pragmatic inferences

Interventions

computerized test for pragmatic inferences OTHER

Computerized tests

Children with Autism Spectrum Disorders; Children with Developmental Language Disorders; Typically Developing children; children with attention-deficit/hyperactivity disorder (ADHD group)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Ch Le Vinatier

Bron, 69678, France

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 190 typically developing children (TD) * A group of 25 children with developmental language disorders (DLD) * A group of 25 children with attention-deficit/hyperactivity disorder (ADHD group)

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 28, 2020
• Study Start: February 7, 2020
• Primary Completion: February 7, 2020
• Study Completion: May 4, 2023
• Last Updated: October 28, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)