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Completed

NCT Number: NCT03861585

Emotional Information Processing in Attention Deficit Disorder With or Without Hyperactivity

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

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Semantic group

Other

The "semantic task" has to categorise semantically (i.e., type of contexts or type of objects) one image at each trial.

Emotional group

Other

The "emotional task" has to evaluate the emotional content (i.e., neutral, positive or negative) of one image at each trial.

Primary outcomes

  1. 1. Accuracy and response time at an explicit emotional evaluation task of visual scenes, by children with Attentional Deficit Hyperactivity Disorder (ADHD)

    Time frame: at baseline Day 0

    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 .

  2. 2. Accuracy and response time at a semantic categorization task of visual scenes, by children with Attentional Deficit Hyperactivity Disorder (ADHD)

    Time frame: at baseline Day 0

    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 .

Secondary outcomes

  1. 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

    Time frame: at baseline Day 0

    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).

  2. 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

    Time frame: at baseline Day 0

    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).

  3. Influence of the image's emotional content (i.e. neutral, positive or negative) on long term memory in ADHD participants

    Time frame: at 1 week from the first evaluation

    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).

  4. Performance on long term memory in ADHD participants

    Time frame: at 1 week from the first evaluation

    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).

Sponsors and collaborators

Lead sponsor

Fondation Lenval

Other

Registry information

Official study title

Attentional and Emotional Processing of Complex Visual Scenes in Children With Attention Deficit Disorder With or Without Hyperactivity

Acronym: TIVE-TDA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 4, 2019
Registry last updated
May 15, 2020

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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