跳至主要内容
临床试验/NCT06286852
NCT06286852进行中(未招募)不适用

Italian Language Validation of The Eating Disorder Examination (EDE) - Child Version

Meyer Children's Hospital IRCCS3 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
250
试验地点
3
主要终点
ChEDE (Child Version of the EatingDisorder Examination)

研究概览

简要总结

Although eating disorders often occur during or after puberty, it is likely that critical antecedent conditions can be established before adolescence. The Eating Disorder Examination has been adapted for children and is described by Bryant - Waugh, Cooper, Taylor and Lask (1996). The EDE is considered the gold standard of measures of eating disorder psychopathology (Wilson, 1993), and this adaptation, which allows its use with a younger age group, is a potentially important addition to the assessment of eating disorders in children. The latest version of EDE, the l7th edition, has now surpassed its predecessors.

The aim of the study is to evaluate the psychometric properties of the Child vers ion EDE (chEDE) translated into Italian, in a sample of patients with eating disorder

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Subjects meet a diagnosis of nutrition and eating disorder, specifically anorexia nervosa, bulimia nervosa, binge eating disorder, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders DSM-5
  • or (for control group) Exclusion of a current or past eating disorder by performing pre-testing (KL subscales - SADS) and BMI 17.5
  • Signed informed consent

排除标准

  • Schizophrenia or other psychotic disorders;
  • Substance misuse in place
  • Medical complications that have the potential to hinder interpretation of results ( e.g., a medical illness that induces weight loss)
  • Presence of physical treatments (including medications) that have the potential to hinder interpretation of results (e.g., chemotherapy for cancer)
  • or (for control group) Presence of a current or past eating disorder and/or Ongoing eating disorder therapy

结局指标

主要结局

ChEDE (Child Version of the EatingDisorder Examination)

时间窗: Immediately after the end of the study (last subject who will complete the qestionnaire)

ChEDE score differences symptoms between patients with eating disorders and control group

K-SADS-PL (Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version) questionnaire

时间窗: Immediately after the end of the study (last subject who will complete the qestionnaire)

K-SADS-PL score differences between experimental group (patients with eating disorders) and control group (adolescents without eating disorders)

次要结局

未报告次要终点

研究者

发起方
Meyer Children's Hospital IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lucilla Bonvini

Principal Investigator

Meyer Children's Hospital IRCCS

研究点 (3)

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