Study of ADHD Children's Sensitivity to Memory Error Production (TDAH-DRM)
Primary Purpose
ADHD
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DRM (Deese, Roediger et McDermott task)
Sponsored by
About this trial
This is an interventional screening trial for ADHD
Eligibility Criteria
Inclusion Criteria:
- Age between 96 and 131 months
- Child referred by a doctor for a neuropsychological assessment
- Child with ADHD diagnosis
- Sufficient command of the French language
- Non-opposition of the child and his/her parents
Exclusion Criteria:
- Severe psychiatric comorbidity: major depressive episode, bipolar disorder, generalized anxiety disorder, autism spectrum disorder
- Major neurological history: severe head trauma, stroke, severe epilepsy, brain tumor
- Repeating a class during school
- Presence of an intellectual disability
- Use of methylphenidate treatment less than 48 hours before the experiment
- Completion of an intellectual assessment using the Wechsler Intelligence Scale for Children (WISC-V) dated less than one year before the meeting
Sites / Locations
- neuropediatrics department - university hospital center of Angers
- Multidisciplinary liberal practice - Acropole Santé
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ADHD
Arm Description
- ADHD children aged between 8 to 10 years old
Outcomes
Primary Outcome Measures
DRM (Deese-Roediger-McDermott task) Performance 1
correct answers
DRM (Deese-Roediger-McDermott task) Performance 2
critical lures
DRM (Deese-Roediger-McDermott task) Performance 3
intruders associated with the lexical field
DRM (Deese-Roediger-McDermott task) Performance 4
non-associated intruders
DRM (Deese-Roediger-McDermott task) Performance 5
average confidence index for each type of answer
Secondary Outcome Measures
Full Information
NCT ID
NCT05365295
First Posted
April 5, 2022
Last Updated
October 18, 2022
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT05365295
Brief Title
Study of ADHD Children's Sensitivity to Memory Error Production
Acronym
TDAH-DRM
Official Title
Sensitivity of Children With Attention Deficit/Hyperactivity Disorder to Memory Error Production
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
October 17, 2022 (Actual)
Study Completion Date
October 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
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 purpose of the study is to test whether children with Attention Deficit/Hyperactivity Disorder (ADHD) are more susceptible to false memory production using a DRM paradigm. The number of "critical decoy production" errors will be analyzed and compared to the calibration of the test.
Detailed Description
During a neuropsychological assessment, as part of the clinical routine, children with a diagnosis of ADHD, without neurological etiology, aged 8 to 10 years will be offered an additional task. This task, a DRM adapted to the child, consists of learning several lists of words. Each list exposes words belonging to the same lexical field, to a concept not explicitly mentioned in the list, called critical lure. Immediately after the presentation of a list, the child is asked to recall as many words as possible. Recall of the critical lure gives an indication of the production of false memories. The number of critical lures produced by these children will be compared to the calibration of the test, currently being published. The investigator will also verify if the production of critical lures can be correlated with other variables such as performance on intellectual, executive and attentional tasks, proposed during the clinical routine assessment.
The investigator hypothesize that ADHD children will recall more critical lures than the norm, and fewer correct responses than the norm.
The data collected is taken from the child's psychological file. The only personal information used, beyond test performance, is the child's gender and age. The procedure is anonymous.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADHD
Arm Type
Experimental
Arm Description
- ADHD children aged between 8 to 10 years old
Intervention Type
Other
Intervention Name(s)
DRM (Deese, Roediger et McDermott task)
Intervention Description
Eight lists of nine words are presented to the participants. Each list is heard once. Immediately afterwards, the child is asked to recall the words he or she remembers. Each child's response is then repeated one by one and the participant is asked to rate his or her confidence in the response on a five-point scale (from "not at all sure" to "100% sure"). A 5-minute break is given in the middle of the task, after the first four lists are presented. The test takes about 20 minutes.
Primary Outcome Measure Information:
Title
DRM (Deese-Roediger-McDermott task) Performance 1
Description
correct answers
Time Frame
20 minutes during DRM DRM (Deese-Roediger-McDermott) task
Title
DRM (Deese-Roediger-McDermott task) Performance 2
Description
critical lures
Time Frame
20 minutes during DRM DRM (Deese-Roediger-McDermott) task
Title
DRM (Deese-Roediger-McDermott task) Performance 3
Description
intruders associated with the lexical field
Time Frame
20 minutes during DRM DRM (Deese-Roediger-McDermott) task
Title
DRM (Deese-Roediger-McDermott task) Performance 4
Description
non-associated intruders
Time Frame
20 minutes during DRM DRM (Deese-Roediger-McDermott) task
Title
DRM (Deese-Roediger-McDermott task) Performance 5
Description
average confidence index for each type of answer
Time Frame
20 minutes during DRM DRM (Deese-Roediger-McDermott) task
10. Eligibility
Sex
All
Minimum Age & Unit of Time
96 Months
Maximum Age & Unit of Time
131 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 96 and 131 months
Child referred by a doctor for a neuropsychological assessment
Child with ADHD diagnosis
Sufficient command of the French language
Non-opposition of the child and his/her parents
Exclusion Criteria:
Severe psychiatric comorbidity: major depressive episode, bipolar disorder, generalized anxiety disorder, autism spectrum disorder
Major neurological history: severe head trauma, stroke, severe epilepsy, brain tumor
Repeating a class during school
Presence of an intellectual disability
Use of methylphenidate treatment less than 48 hours before the experiment
Completion of an intellectual assessment using the Wechsler Intelligence Scale for Children (WISC-V) dated less than one year before the meeting
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Martin
Organizational Affiliation
UH Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
neuropediatrics department - university hospital center of Angers
City
Angers
Country
France
Facility Name
Multidisciplinary liberal practice - Acropole Santé
City
Rezé
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of ADHD Children's Sensitivity to Memory Error Production
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