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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Feeding and Eating Disorders of Childhood
• Intervention / Treatment: Behavioral: Administration of K-SADS-PL- Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version (Kaufmann, 2002); Behavioral: Administration of ChEDE- Child Version of the EatingDisorder Examination

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• Italy
  • Firenze, Italy
    • Meyer Children's Hospital IRCCS
  • Firenze, Italy
    • USL Toscana Centro
  • Garda, Italy
    • Ospedale Villa Garda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects with a diagnosis of nutrition and eating disorder, particularly anorexia nervosa, bulimia nervosa, binge eating disorder, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders DSM-5

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental group; Subjects meeting a diagnosis of nutrition and eating disorder	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); Behavioral: Administration of ChEDE- Child Version of the EatingDisorder Examination; Administration of ChEDE- Child Version of the EatingDisorder Examination
Control group; children - adolescents from various schools in the Florence area, chosen through statistical criteria based on age, gender, ethnicity	Behavioral: Administration of ChEDE- Child Version of the EatingDisorder Examination; Administration of ChEDE- Child Version of the EatingDisorder Examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Meyer Children's Hospital IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Feeding and Eating Disorders of Childhood
• Other Study ID Numbers: EDE BA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No