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临床试验/NCT03719950
NCT03719950已完成不适用

Monocentric Study on the Quality of Life Among Adolescents With Attention Deficit/Hyperactivity Disorder

Centre Psychothérapique de Nancy1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
The KIDSCREEN-27

研究概览

简要总结

Attention Deficit Hyperactivity Disorder (ADHD) with a overall prevalence of 5.3% is one of the most common neurobehavioral disorders in children. In the foreign literature, many studies bring to light in children and adolescents the negative impact of ADHD on overall quality of life. Some of these studies were able to identify the fact that the higher the age of ADHD children or adolescents, the lower the quality of life. Currently, to our knowledge, only a few European studies have demonstrated the negative impact of ADHD on the quality of life of children and adolescents. In addition, these studies used only questionnaires intended for parents and not for children or adolescents.

During a regular follow-up consultation with their referent child psychiatrist, adolescents accompanied by at least one of their parents will be informed of the modalities of our study. A newsletter will be delivered to parents and one to the adolescent. If neither the adolescent nor the parents is opposed to participate, the child psychiatrist will register the patient on the list of study participants. He will also fill out a medico-social information sheet about the adolescent as to summarize the data in the medical record. At the end of this consultation, in the waiting room, adolescents will answer questionnaires KIDSCREEN-27 and MSPSS; their parents will complete the CBCL questionnaire. These questionnaires will be handed to the secretary who will put them back in the patient's record. The KIDSCREEN-27, MSPSS and CBCL questionnaires as well as the medico-social information sheet will be source documents. The principal investigator or one of the associates investigators will complete the case report form from these source documents. For this purpose the data will be entered anonymously into a data entry software on a computer server secured by the Centre Psychothérapique de Nancy (CPN). Then, anonymous data from the software will be forwarded to Dr. Epstein of the Clinical Investigation Center for statistical analysis. The study will begin when the favourable opinion of the Ethical Research Comittees will be obtained and the study will last one year.

详细描述

Cross-sectional, descriptive epidemiological study based on single-centre trials

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents aged 12 to 18 years
  • Diagnosis of ADHD (f 90.0) ascertained by a child psychiatry according to CIM-10 criteria
  • Seen by a child psychiatrist in consultation and accompanied by at least one of their parents
  • Adolescents and at least one parent who has received enlightened information about the study
  • Non-opposition to participate in the study gathered from at least one of their parents
  • Patient affiliated or beneficiary of a social security scheme

排除标准

  • Illiteracy of the parents or the adolescents
  • Difficulties to understand french for the parents or the adolescents

结局指标

主要结局

The KIDSCREEN-27

时间窗: Day 0 (=day of inclusion = the only visit of the study)

A shorter version of KIDSCREEN-52 which is Health-Related Quality of Life Questionnaire for Children and Adolescents aged from 8 to 18 years The adolescent will consult his child psychiatrist and after he will answer to the questionnaire KIDSCREEN-27 during estimated time of fifteen minutes.

次要结局

  • The Child Behavior Check List (CBCL)(Day 0 (=day of inclusion = the only visit of the study))
  • The Multidimensional Scale of Perceived Social Support (MSPSS)(Day 0 (=day of inclusion = the only visit of the study))

研究者

发起方
Centre Psychothérapique de Nancy
申办方类型
Other
责任方
Sponsor

研究点 (1)

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