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CompletedNCT03861585TIVE-TDAUpdated May 15, 2020

Emotional Information Processing in Attention Deficit Disorder With or Without Hyperactivity

An interventional study of Semantic group and Emotional group in Attention Deficit Disorder With Hyperactivity and Attention Deficit Disorder Without Hyperactivity, sponsored by Fondation Lenval. Completed at 1 site in France. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2020-05-15.

Sponsored by Fondation Lenval · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
7 Years to 12 Years
Sex
All
01

Study 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

Read the detailed 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).

02

Conditions studied

  • Attention Deficit Disorder With Hyperactivity
  • Attention Deficit Disorder Without Hyperactivity
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 54 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

Fondation Lenval is the lead sponsor of 60 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    semantic group

    Half of the participants (named the "semantic group") perform a semantic categorisation task.

    Other: Semantic group

  • Experimental
    emotional group

    Half of the participants (named the "emotional group") perform an emotional evaluation task.

    Other: Emotional group

Interventions

  • OtherSemantic group

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

  • OtherEmotional group

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

06

What researchers measure

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)

    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 .

    Time frame: at baseline Day 0

  2. 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 .

    Time frame: at baseline Day 0

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

    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).

    Time frame: at baseline Day 0

  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

    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).

    Time frame: at baseline Day 0

  3. 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).

    Time frame: at 1 week from the first evaluation

  4. 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).

    Time frame: at 1 week from the first evaluation

07

Study locations

1 site
  • Hôpitaux Pédiatriques de Nice CHU-Lenval
    Nice, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03861585
Lead sponsor
Fondation Lenval
Responsible party
Sponsor
First posted
Mar 4, 2019
Start date
Mar 15, 2019
Primary completion
Mar 11, 2020
Completion
Mar 11, 2020
Last update
May 15, 2020

Study contacts

FOSSOUD Catherine, MD
principal investigator · Fondation Lenval - Nice Children Hôpitaux Pédiatriques de Nice

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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