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

Feeding and Eating Disorders of Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06286852
• Other study ID #: EDE BA
• Status: Active, not recruiting
• Start date: November 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Meyer Children's Hospital IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Feeding and Eating Disorders of Childhood

Intervention

Behavioral:
• Administration of K-SADS-PL- Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version (Kaufmann, 2002)
Administration of 1) K-SADS-PL- Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version (Kaufmann, 2002)
• Administration of ChEDE- Child Version of the EatingDisorder Examination
Administration of ChEDE- Child Version of the EatingDisorder Examination

Locations

Country	Name	City	State
Italy	Meyer Children's Hospital IRCCS	Firenze
Italy	USL Toscana Centro	Firenze
Italy	Ospedale Villa Garda	Garda

Sponsors (1)

Lead Sponsor	Collaborator
Meyer Children's Hospital IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	K-SADS-PL (Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version) questionnaire	K-SADS-PL score differences between experimental group (patients with eating disorders) and control group (adolescents without eating disorders)	Immediately after the end of the study (last subject who will complete the qestionnaire)
Primary	ChEDE (Child Version of the EatingDisorder Examination)	ChEDE score differences symptoms between patients with eating disorders and control group	Immediately after the end of the study (last subject who will complete the qestionnaire)