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临床试验/NCT03565250
NCT03565250Unknown不适用

A Study of Identity Building in Children With Attention Deficit Hyperactivity Disorder (ADHD)

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年7月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Identity building

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

ADHD patients

Experimental

children aged 8-12 ans with ADHD

干预措施: self understanding interview (Other)

control

Active Comparator

children aged 8-12 ans without ADHD

干预措施: self understanding interview (Other)

结局指标

主要结局

Identity building

时间窗: 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

次要结局

  • working memory(baseline)
  • executive functions(baseline)
  • • Intensity score of ADHD(baseline)
  • Self esteem(baseline)
  • Causal style(baseline)
  • Global Assessment of Functioning Scale(baseline)
  • Long-term memory(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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