Italian Language Validation of The Eating Disorder Examination (EDE) - Child Version (NCT06286852) | Clinical Trial Compass
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Italian Language Validation of The Eating Disorder Examination (EDE) - Child Version
Italy250 participantsStarted 2022-11-01
Plain-language summary
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
Who can participate
Age range
8 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
K-SADS-PL (Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version) questionnaire
Timeframe: Immediately after the end of the study (last subject who will complete the qestionnaire)
2
ChEDE (Child Version of the EatingDisorder Examination)
Timeframe: Immediately after the end of the study (last subject who will complete the qestionnaire)