Clinical trial NCT03565250: A Study of Identity Building in Children With ADHD
Official title: A Study of Identity Building in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Disorder with Hyperactivity
Self concept
Child
Neuropsychology
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Ecole Pratique des Hautes Etudes
First posted: 2018-06-21
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Identity building
timeFrame: baseline
Secondary outcomes:
measure: • Intensity score of ADHD
timeFrame: baseline
measure: Self esteem
timeFrame: baseline
measure: Causal style
timeFrame: baseline
measure: Global Assessment of Functioning Scale
timeFrame: baseline
measure: working memory
timeFrame: baseline
measure: executive functions
timeFrame: baseline
measure: Long-term memory
timeFrame: baseline
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
affiliation: CHU CAEN
name: Marie-Amélie Tordjman-Madigand, MD
role: PRINCIPAL_INVESTIGATOR
References: