Attention Deficit Disorder With HyperactivityTIVE-TDANCT03861585
Emotional Information Processing in Attention Deficit Disorder With or Without Hyperactivity
A study testing Semantic group and Emotional group in people with Attention Deficit Disorder With Hyperactivity and Attention Deficit Disorder Without Hyperactivity, run by Fondation Lenval at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Attention Deficit Disorder Without Hyperactivity
- What is being tested?
- Semantic group and Emotional group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2019to 11 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- -History of neurological troubles, dysphasia, autistic spectrum disorder, intellectual disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attentional and Emotional Processing of Complex Visual Scenes in Children With 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
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).
- Conditions
- Attention Deficit Disorder With Hyperactivity, Attention Deficit Disorder Without Hyperactivity
- Being tested
- Semantic group, Emotional group
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semantic groupOther
The "semantic task" has to categorise semantically (i.e., type of contexts or type of objects) one image at each trial.
Emotional groupOther
The "emotional task" has to evaluate the emotional content (i.e., neutral, positive or negative) of one image at each trial.
| Study group | Role | What they receive |
|---|---|---|
| semantic group | Experimental | Half of the participants (named the "semantic group") perform a semantic categorisation task. Receives: Other: Semantic group |
| emotional group | Experimental | Half of the participants (named the "emotional group") perform an emotional evaluation task. Receives: Other: Emotional group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: at baseline Day 0
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 .
Measured: at baseline Day 0
Secondary outcomes (4)
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).
Measured: at baseline Day 0
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).
Measured: at baseline Day 0
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).
Measured: at 1 week from the first evaluation
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).
Measured: at 1 week from the first evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start15 Mar 2019
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FOSSOUD Catherine, MD, Principal investigator, Fondation Lenval - Nice Children Hôpitaux Pédiatriques de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861585
- Sponsor's protocol ID
- 18-HPNCL-07
- Acronym
- TIVE-TDA
- Status last verified
- May 2019
- First submitted
- 21 Feb 2019
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attentional and Emotional Processing of Complex Visual Scenes in Children With Attention Deficit Disorder With or Without Hyperactivity
- ClinicalTrials.gov ID
- NCT03861585
- Acronym / sponsor ID
- TIVE-TDA / 18-HPNCL-07
- Conditions
- Attention Deficit Disorder With Hyperactivity, Attention Deficit Disorder Without Hyperactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| semantic group | Experimental | Other: Semantic groupHalf of the participants (named the "semantic group") perform a semantic categorisation task. |
| emotional group | Experimental | Other: Emotional groupHalf of the participants (named the "emotional group") perform an emotional evaluation task. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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…………………….
Key exclusion criteria (1 listed)
- -History of neurological troubles, dysphasia, autistic spectrum disorder, intellectual disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semantic groupThe "semantic task" has to categorise semantically (i.e., type of contexts or type of objects) one image at each trial. | Other | semantic group |
| Emotional groupThe "emotional task" has to evaluate the emotional content (i.e., neutral, positive or negative) of one image at each trial. | Other | emotional group |
Primary outcome
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. 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 .
4 secondary outcomes
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
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
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
Performance on long term memory in ADHD participants
Time frame: at 1 week from the first evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FOSSOUD Catherine, MD principal investigator
Fondation Lenval - Nice Children Hôpitaux Pédiatriques de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semantic group and Emotional group in people with Attention Deficit Disorder With Hyperactivity and Attention Deficit Disorder Without Hyperactivity, run by Fondation Lenval at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.