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

NCT06286852 | Active Not Recruiting

• 1 other identifier: EDE BA
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Feeding and Eating Disorders of Childhood

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

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); Behavioral: 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

Interventions

Administration of K-SADS-PL- Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version (Kaufmann, 2002) BEHAVIORAL

Administration of 1) K-SADS-PL- Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version (Kaufmann, 2002)

Experimental group

Administration of ChEDE- Child Version of the EatingDisorder Examination BEHAVIORAL

Administration of ChEDE- Child Version of the EatingDisorder Examination

Control group; Experimental group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (3)

Meyer Children's Hospital IRCCS

Florence, Italy

Location

USL Toscana Centro

Florence, Italy

Location

Ospedale Villa Garda

Garda, Italy

Location

MeSH Terms

Conditions

Feeding and Eating Disorders of Childhood

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 29, 2024
• Study Start: November 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: June 30, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)