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Emotional Information Processing in Attention Deficit Disorder With or Without Hyperactivity (TIVE-TDA)

Primary Purpose

Attention Deficit Disorder With Hyperactivity, Attention Deficit Disorder Without Hyperactivity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Semantic group
Emotional group
Sponsored by
Fondation Lenval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpitaux Pédiatriques de Nice CHU-Lenval

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

semantic group

emotional group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 .
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 .

Secondary Outcome Measures

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).
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).
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).
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).

Full Information

First Posted
February 21, 2019
Last Updated
May 14, 2020
Sponsor
Fondation Lenval
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1. Study Identification

Unique Protocol Identification Number
NCT03861585
Brief Title
Emotional Information Processing in Attention Deficit Disorder With or Without Hyperactivity
Acronym
TIVE-TDA
Official Title
Attentional and Emotional Processing of Complex Visual Scenes in Children With Attention Deficit Disorder With or Without Hyperactivity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
March 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity, Attention Deficit Disorder Without Hyperactivity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
semantic group
Arm Type
Experimental
Arm Description
Half of the participants (named the "semantic group") perform a semantic categorisation task.
Arm Title
emotional group
Arm Type
Experimental
Arm Description
Half of the participants (named the "emotional group") perform an emotional evaluation task.
Intervention Type
Other
Intervention Name(s)
Semantic group
Intervention Description
The "semantic task" has to categorise semantically (i.e., type of contexts or type of objects) one image at each trial.
Intervention Type
Other
Intervention Name(s)
Emotional group
Intervention Description
The "emotional task" has to evaluate the emotional content (i.e., neutral, positive or negative) of one image at each trial.
Primary Outcome Measure Information:
Title
1. Accuracy and response time at an explicit emotional evaluation task of visual scenes, by children with Attentional Deficit Hyperactivity Disorder (ADHD)
Description
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
Title
2. Accuracy and response time at a semantic categorization task of visual scenes, by children with Attentional Deficit Hyperactivity Disorder (ADHD)
Description
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 Outcome Measure Information:
Title
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
Description
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
Title
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
Description
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
Title
Influence of the image's emotional content (i.e. neutral, positive or negative) on long term memory in ADHD participants
Description
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
Title
Performance on long term memory in ADHD participants
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FOSSOUD Catherine, MD
Organizational Affiliation
Fondation Lenval - Nice Children Hôpitaux Pédiatriques de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Pédiatriques de Nice CHU-Lenval
City
Nice
Country
France

12. IPD Sharing Statement

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