A Study of Identity Building in Children With ADHD (SID-ADHD)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
self understanding interview
Sponsored by
About this trial
This is an interventional basic science trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Disorder with Hyperactivity, Self concept, Child, Neuropsychology
Eligibility Criteria
Inclusion Criteria:
Patient group:
- Child aged 8 to 12,
- clinical diagnosis of ADHD according to DSM-V criteria
- Informed consent signed by the holder (s) of the exercise of parental authority and specifying the decision of the child himself,
- Subject having French as mother tongue,
- Subject affiliated to the social security system.
Control group:
- Child aged 8 to 12,
- Not suffering from ADHD according to DSM-V criteria
- Informed consent signed by the holder (s) of the exercise of parental authority and specifying the decision the child himself,
- Subjects with French as their mother tongue,
- Subject affiliated to the social security system.
Exclusion Criteria:
- Sensory disorders,
- Pathology of the brain (head trauma, epilepsy, others),
- Major psychiatric comorbidity (current depressive episode, schizophrenia, bipolar disorder, autism spectrum disorders),
- Anticonvulsant treatment
- Consumption of toxic (drug, alcohol).
- Mental retardation QI less than 70
Sites / Locations
- Caen University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ADHD patients
control
Arm Description
children aged 8-12 ans with ADHD
children aged 8-12 ans without ADHD
Outcomes
Primary Outcome Measures
Identity building
Self understanding interview (Damon ahd Hart): analysis and developmental characterization of the child's discourse on himself,
Model distinguishes the two components of Self:
the me-self: aggregation of self-knowledge;
The I self: the Self-as-subject; the subjective component that performs the act of self-knowledge.
to attest to identity development:
The average level of identity development for me-self as a whole is calculated by summing the total number of segments in each developmental level multiplied by his cardinal, all divided by the total number of segments
Breakdown of segments of speech in the 4 modal levels (superficial, self-centered, interactive, codified) for each of the identity dimensions of the component of me-self (Physics, Active, Social, Psychological, Continuity, Agentivity, Distinction Self / Other) ,
The best developmental level for each dimension of the I-Self component 0 à 4
Secondary Outcome Measures
• Intensity score of ADHD
18 items exploring hyperactivity, impulsivity and inattention symptômes rated on a scale of 4 points:
0: Rarely or never
1: Some times
2: Often
3: Very often
a score greater than or equal to 28 is required to qualify a significant ADHD. (min=0-max=54)
Self esteem
The Child Perception Profile is the French adaptation (Pierrhumbert) of the Self-Perception Profile for Children (Harter).This self-questionnaire for children aged 8 to 13 explores self-esteem through 30 questions about daily life, coded on a scale from 1 to 4. First, the young person chooses the description that looks the most; he then determines how much he looks like him.
It provides an overall self-esteem score and six sub-scores: academic, social, physical, appearance, driving and self-worth.
Each dimension is explored by 5 questions, the sub-scores are obtained by adding the items, the overall self-esteem score is obtained by adding the sub-scores.
The higher the score, the higher the self-esteem
Causal style
The Child Causal Style Questionnaire is a self-administered questionnaire that assesses the child's "locus of control", that is, how much does he attribute responsibility for his failures and successes to oneself (internal locus) or to others (external locus). It consists of 24 items describing plausible events, 12 positive and 12 negative, for which the child must choose a cause.
Global Assessment of Functioning Scale
The Global Assessment of Functioning (GAF) is a numeric scale used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of an individual, e.g., how well one is meeting various problems-in-living. Scores range from 100 (extremely high functioning) to 1 (severely impaired).
working memory
memory of numbers, memory of images in Wechsler Intelligence Scale for Children 5
executive functions
BRIEF Wisconsin sorting card test
Long-term memory
History recall test (from children memory scale ; Cohen)
Full Information
NCT ID
NCT03565250
First Posted
May 16, 2018
Last Updated
July 12, 2018
Sponsor
University Hospital, Caen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Ecole Pratique des Hautes Etudes
1. Study Identification
Unique Protocol Identification Number
NCT03565250
Brief Title
A Study of Identity Building in Children With ADHD
Acronym
SID-ADHD
Official Title
A Study of Identity Building in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2018 (Anticipated)
Primary Completion Date
August 4, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Ecole Pratique des Hautes Etudes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Context: Attention Deficit Hyperactivity Disorder (ADHD), a major public health issue, is a neurodevelopmental disorder characterized by disturbance of attention, pathological impulsivity and a variable level of psychomotor hyperactivity. In addition to medium-term repercussions such as school failure or family dysfunction, these children have difficulties in dealing with emotions, metacognition and self-awareness that have serious consequences for self-regulation and identity construction.
Objective: To investigate identity building in children with ADHD and explore its links with the severity of the disorder and associated neuropsychological disturbances.
Material and method: 20 childrens with ADHD and 20 controls will be recruited over a 24-month period. They will be administered the Damon and Hart's Self-Understanding Interview, exploring 7 identity domains: Physical, Active, Social, Psychological, Continuity, Agentivity, Distinction Self/Other. The severity of ADHD, neuropsychological functioning (attention, working memory, executive functions, long-term memory), self-esteem and internal/external attributive style (locus of control) will be assessed by validated scales. The overall level of identity development and in each dimension will be compared between patients and controls. Within patients, the correlations between level of identity development and the severity of ADHD will be explored, as well as with neuropsychological functioning, with statistical control of age.
Assumptions: The investigators hypothesize that children with ADHD will exhibit a significantly lower level of identity development than controls, which will be positively correlated with neuropsychological functioning, and negatively correlated with the severity of ADHD.
Detailed Description
Visit 1: the physician will check inclusion and non-inclusion criteria and co-morbidities of patients and controls using a semi-structured interview (K-SADS-PL). He/She will also assess the overall functioning level of patients and controls (GAF) and will evaluate for patients only the severity of ADHD using ADHD-RS.
Visits number 2 and 3: Cognitive and neuropsychological evaluations:
2 consultations to be distributed in one month depending on the availability of patients (no time limit imposed between the 2 consultations) In order to investigate any cognitive dysfunctions, patients and controls will be referred to the neuropsychologists of the department concerned (pediatrics or child and adolescent psychiatry). They will perform the WISC-V, CPT, Wisconsin SCD, CMS Stories Test. Several questionnaires will be completed by parents and/or children : BRIEF, Self-esteem Questionnaire, Causal Style Questionnaire. This whole assessment will require a total of 2 consultations, one of 1:30 and the second of about 1 hour. Patients on methylphenidate medication should be discontinued the same day during the second session of the neuropsychological check-up.
Visit number 4: Self-Understanding Interview: 1 hour consultation The interview specifically assessing self-understanding will be conducted with children suffering from ADHD and control children. This investigation consists of an interview requiring 1h consultation for which patients should have taken their usual treatment by MPH if necessary. An audio recording of this test will be made.
Inclusion and the first psychological assessment session (visit 1 and visit 2) can be done on the same day. All 3 appointments must be completed in a period of less than 3 months after inclusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention Deficit Disorder with Hyperactivity, Self concept, Child, Neuropsychology
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ADHD patients
Arm Type
Experimental
Arm Description
children aged 8-12 ans with ADHD
Arm Title
control
Arm Type
Active Comparator
Arm Description
children aged 8-12 ans without ADHD
Intervention Type
Other
Intervention Name(s)
self understanding interview
Intervention Description
semi-structured interview designed for assessment of identity according to Damon & Hart's 7-dimension develomental model
Primary Outcome Measure Information:
Title
Identity building
Description
Self understanding interview (Damon ahd Hart): analysis and developmental characterization of the child's discourse on himself,
Model distinguishes the two components of Self:
the me-self: aggregation of self-knowledge;
The I self: the Self-as-subject; the subjective component that performs the act of self-knowledge.
to attest to identity development:
The average level of identity development for me-self as a whole is calculated by summing the total number of segments in each developmental level multiplied by his cardinal, all divided by the total number of segments
Breakdown of segments of speech in the 4 modal levels (superficial, self-centered, interactive, codified) for each of the identity dimensions of the component of me-self (Physics, Active, Social, Psychological, Continuity, Agentivity, Distinction Self / Other) ,
The best developmental level for each dimension of the I-Self component 0 à 4
Time Frame
baseline
Secondary Outcome Measure Information:
Title
• Intensity score of ADHD
Description
18 items exploring hyperactivity, impulsivity and inattention symptômes rated on a scale of 4 points:
0: Rarely or never
1: Some times
2: Often
3: Very often
a score greater than or equal to 28 is required to qualify a significant ADHD. (min=0-max=54)
Time Frame
baseline
Title
Self esteem
Description
The Child Perception Profile is the French adaptation (Pierrhumbert) of the Self-Perception Profile for Children (Harter).This self-questionnaire for children aged 8 to 13 explores self-esteem through 30 questions about daily life, coded on a scale from 1 to 4. First, the young person chooses the description that looks the most; he then determines how much he looks like him.
It provides an overall self-esteem score and six sub-scores: academic, social, physical, appearance, driving and self-worth.
Each dimension is explored by 5 questions, the sub-scores are obtained by adding the items, the overall self-esteem score is obtained by adding the sub-scores.
The higher the score, the higher the self-esteem
Time Frame
baseline
Title
Causal style
Description
The Child Causal Style Questionnaire is a self-administered questionnaire that assesses the child's "locus of control", that is, how much does he attribute responsibility for his failures and successes to oneself (internal locus) or to others (external locus). It consists of 24 items describing plausible events, 12 positive and 12 negative, for which the child must choose a cause.
Time Frame
baseline
Title
Global Assessment of Functioning Scale
Description
The Global Assessment of Functioning (GAF) is a numeric scale used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of an individual, e.g., how well one is meeting various problems-in-living. Scores range from 100 (extremely high functioning) to 1 (severely impaired).
Time Frame
baseline
Title
working memory
Description
memory of numbers, memory of images in Wechsler Intelligence Scale for Children 5
Time Frame
baseline
Title
executive functions
Description
BRIEF Wisconsin sorting card test
Time Frame
baseline
Title
Long-term memory
Description
History recall test (from children memory scale ; Cohen)
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient group:
Child aged 8 to 12,
clinical diagnosis of ADHD according to DSM-V criteria
Informed consent signed by the holder (s) of the exercise of parental authority and specifying the decision of the child himself,
Subject having French as mother tongue,
Subject affiliated to the social security system.
Control group:
Child aged 8 to 12,
Not suffering from ADHD according to DSM-V criteria
Informed consent signed by the holder (s) of the exercise of parental authority and specifying the decision the child himself,
Subjects with French as their mother tongue,
Subject affiliated to the social security system.
Exclusion Criteria:
Sensory disorders,
Pathology of the brain (head trauma, epilepsy, others),
Major psychiatric comorbidity (current depressive episode, schizophrenia, bipolar disorder, autism spectrum disorders),
Anticonvulsant treatment
Consumption of toxic (drug, alcohol).
Mental retardation QI less than 70
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Amélie Tordjman-Madigand
Phone
0231272309
Email
tordjman-ma@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fabian Guenole
Phone
0231272309
Email
guenole-f@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Amélie Tordjman-Madigand, MD
Organizational Affiliation
CHU caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
tordjman-ma@chu-caen.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study of Identity Building in Children With ADHD
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