Attention Deficit Hyperactivity DisorderSID-ADHDNCT03565250
A Study of Identity Building in Children With ADHD
A study testing self understanding interview in people with Attention Deficit Hyperactivity Disorder, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- self understanding interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2018to 31 Dec 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen
tordjman-ma@chu-caen.fr
About this study
Official title: A Study of Identity Building in Children With Attention Deficit Hyperactivity Disorder (ADHD)
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.
Read more
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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- self understanding interview
- Keywords
- Attention Deficit Disorder with Hyperactivity, Self concept, Child, Neuropsychology
- 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.
self understanding interviewOther
semi-structured interview designed for assessment of identity according to Damon \& Hart's 7-dimension develomental model
| Study group | Role | What they receive |
|---|---|---|
| ADHD patients | Experimental | children aged 8-12 ans with ADHD Receives: Other: self understanding interview |
| control | Active comparator | children aged 8-12 ans without ADHD Receives: Other: self understanding interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (7)
• 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)
Measured: baseline
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
Measured: baseline
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.
Measured: baseline
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).
Measured: baseline
working memory
memory of numbers, memory of images in Wechsler Intelligence Scale for Children 5
Measured: baseline
executive functions
BRIEF Wisconsin sorting card test
Measured: baseline
Long-term memory
History recall test (from children memory scale ; Cohen)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start20 Jul 2018 (estimated)
- Primary completion4 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Ecole Pratique des Hautes Etudes
- Responsible party
- Sponsor
- Investigators
- Marie-Amélie Tordjman-Madigand, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565250
- Sponsor's protocol ID
- 17-011
- Acronym
- SID-ADHD
- Status last verified
- Apr 2018
- First submitted
- 16 May 2018
- Last updated
- 13 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Identity Building in Children With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT03565250
- Acronym / sponsor ID
- SID-ADHD / 17-011
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Disorder with Hyperactivity, Self concept, Child, Neuropsychology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Ecole Pratique des Hautes Etudes
- Study start
- 20 Jul 2018 (estimated)
- Primary completion
- 4 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 21 Jun 2018 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD patients | Experimental | Other: self understanding interviewchildren aged 8-12 ans with ADHD |
| control | Active comparator | Other: self understanding interviewchildren aged 8-12 ans without ADHD |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
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 |
|---|---|---|
| self understanding interviewsemi-structured interview designed for assessment of identity according to Damon \& Hart's 7-dimension develomental model | Other | ADHD patients, control |
Primary outcome
Identity building
Time frame: baseline
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
7 secondary outcomes
• Intensity score of ADHD
Time frame: baseline
Self esteem
Time frame: baseline
Causal style
Time frame: baseline
Global Assessment of Functioning Scale
Time frame: baseline
working memory
Time frame: baseline
executive functions
Time frame: baseline
Long-term memory
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Marie-Amélie Tordjman-Madigand, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self understanding interview in people with Attention Deficit Hyperactivity Disorder, run by University Hospital, Caen 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 12 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Amélie Tordjman-Madigand (0231272309, tordjman-ma@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identity building (time frame: baseline). 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 13 Jul 2018; AzTrials last refreshed its copy on 6 Nov 2026.