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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03861585
Other study ID # 18-HPNCL-07
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2019
Est. completion date March 11, 2020

Study information

Verified date May 2019
Source Fondation Lenval
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to analyse explicit and implicit emotional information processing abilities in children with attention deficit disorder with or without hyperactivity


Description:

The main symptoms of Attentional Deficit Hyperactivity Disorder (ADHD) are inattention, motor agitation and impulsivity. However, other dysfunctions affecting the quality of life remain poorly studied: lack of understanding and management of emotions, focus on the local aspects of a visual scene limiting the ability to assign a general meaning to the scene and alteration of long-term memory encoding. This study aims to analyse these difficulties using different tasks requiring processing of rich and varied everyday images, having high ecological validity. It involves the participation of 56 boys and girls with ADHD, aged 7 to 12 years. A first phase examines the immediate understanding of images using two tasks: semantic categorization (Experiment 1) and emotional evaluation (Experiment 2) of images with positive, negative or neutral emotional valence, and depicting real environments (natural vs. manufactured contexts) or foreground objects pasted into a noise background (inanimate objects vs. animals vs. people. In each trial, one context image and one object image are presented briefly and simultaneously, one in each visual field. In order to be appropriately understood in both their semantic and emotional contents, context images will require more global processing, while object images will require more local, detailed processing. Their semantic (Exp. 1) and emotional (Exp. 2) consistency is manipulated. A week later, the participants have to perform a memory task requiring old/new recognition in a two-alternative forced choice (2AFC) paradigm that presents in each trial a pair of images (one old, one new) having the same emotional valence (Exp. 3). The study will characterize the specificities of processing and representing visual emotional information in ADHD children. The results will be compared with those from a previous study we conducted with the same methodology on neuro-typical children (controls).


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date March 11, 2020
Est. primary completion date March 11, 2020
Accepts healthy volunteers No
Gender All
Age group 7 Years to 12 Years
Eligibility Inclusion Criteria:

- Children between 7 and 12 years old…………………………….

- Normal or corrected visual acuity ……………………………….

- ADHD diagnostic given by a doctor according to DSM 5 criteria (Diagnostic and Statistical Manual of Mental Disorders)

- Free from drug treatment until 24 hours before the experiment session……………………….

- Affiliation to a social security system…………………….

- Signature of the authorization documents from one parent or the holder of parental authority

Exclusion Criteria:

-History of neurological troubles, dysphasia, autistic spectrum disorder, intellectual disabilities

Study Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder With Hyperactivity
  • Attention Deficit Disorder Without Hyperactivity
  • Disease
  • Hyperkinesis

Intervention

Other:
Semantic group
The "semantic task" has to categorise semantically (i.e., type of contexts or type of objects) one image at each trial.
Emotional group
The "emotional task" has to evaluate the emotional content (i.e., neutral, positive or negative) of one image at each trial.

Locations

Country Name City State
France Hôpitaux Pédiatriques de Nice CHU-Lenval Nice

Sponsors (1)

Lead Sponsor Collaborator
Fondation Lenval

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1. Accuracy and response time at an explicit emotional evaluation task of visual scenes, by children with Attentional Deficit Hyperactivity Disorder (ADHD) The performance at the emotional evaluation task is analyzed by association of two separate outcomes measures: measure of efficiency by the accuracy (i.e. proportion of correct response) and measure of the effectiveness by the response time at the correct trials (in milliseconds). This experiment analyzed the explicit processing of visual scenes' emotional content . at baseline Day 0
Primary 2. Accuracy and response time at a semantic categorization task of visual scenes, by children with Attentional Deficit Hyperactivity Disorder (ADHD) The performance at the semantic categorization task is analyzed by association of two separate outcomes measures: measure of efficiency by the accuracy (i.e. proportion of correct response) and measure of the effectiveness by the response time at the correct trials (in milliseconds). This experiment analyzed the implicit processing of visual scenes' emotional content . at baseline Day 0
Secondary Proportion and response time of correct response for the contextual images compared to the local images at the semantic categorization task for ADHD's participants The performance is analyzed by association of two separate outcomes measures: measure of efficiency by the accuracy (i.e. proportion of correct response) and measure of the effectiveness by the response time at the correct trials (in milliseconds). at baseline Day 0
Secondary Proportion and response time of correct response for the contextual images compared to the local images at the emotional evaluation task for ADHD's participants The performance is analyzed by association of two separate outcomes measures: measure of efficiency by the accuracy (i.e. proportion of correct response) and measure of the effectiveness by the response time at the correct trials (in milliseconds). at baseline Day 0
Secondary Influence of the image's emotional content (i.e. neutral, positive or negative) on long term memory in ADHD participants The performance, in a two-alternative forced choice (2 AFC) image recognition, is analyzed by two separate outcomes measures: measure of efficiency by the accuracy (i.e. proportion of correct response) and measure of the effectiveness by the response time (in milliseconds). at 1 week from the first evaluation
Secondary Performance on long term memory in ADHD participants The performance, in a two-alternative forced choice (2 AFC) image recognition, is analyzed by two separate outcomes measures: measure of efficiency by the accuracy (i.e. proportion of correct response) and measure of the effectiveness by the response time (in milliseconds). at 1 week from the first evaluation
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