Feeding and Eating Disorders of ChildhoodNCT06286852
Italian Language Validation of The Eating Disorder Examination (EDE) - Child Version
An observational study of Feeding and Eating Disorders of Childhood, run by Meyer Children's Hospital IRCCS at 3 sites in Italy.
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). Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Feeding and Eating Disorders of Childhood
- What is being tested?
- Administration of K-SADS-PL- Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version (Kaufmann, 2002) and Administration of ChEDE- Child Version of the EatingDisorder Examination
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Nov 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Meyer Children's Hospital IRCCS
Florence
USL Toscana Centro
Florence
Ospedale Villa Garda
Garda
About this study
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
- Being tested
- Administration of 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
- Medical subject headings
- Feeding and Eating Disorders of Childhood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of K-SADS-PL- Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version (Kaufmann, 2002)Behavioural
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 ExaminationBehavioural
Administration of ChEDE- Child Version of the EatingDisorder Examination
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Subjects meeting a diagnosis of nutrition and eating disorder Receives: 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 Receives: Behavioral: Administration of ChEDE- Child Version of the EatingDisorder Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Immediately after the end of the study (last subject who will complete the qestionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Nov 2022
- Primary completion30 Dec 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding and Eating Disorders of ChildhoodStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucilla Bonvini, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286852
- Sponsor's protocol ID
- EDE BA
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Language Validation of The Eating Disorder Examination (EDE) - Child Version
- ClinicalTrials.gov ID
- NCT06286852
- Acronym / sponsor ID
- EDE BA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | 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 ExaminationSubjects meeting a diagnosis of nutrition and eating disorder |
| Control group | – | Behavioral: Administration of ChEDE- Child Version of the EatingDisorder Examinationchildren - adolescents from various schools in the Florence area, chosen through statistical criteria based on age, gender, ethnicity |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | Experimental group |
| Administration of ChEDE- Child Version of the EatingDisorder ExaminationAdministration of ChEDE- Child Version of the EatingDisorder Examination | Behavioural | Control group, Experimental group |
Primary outcome
K-SADS-PL (Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version) questionnaire
Time frame: 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)
ChEDE (Child Version of the EatingDisorder Examination)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Feeding and Eating Disorders of Childhood
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Not yet recruiting
Parent-Based Intervention for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)
Anxiety Disorder of Adolescence, Avoidant / Restrictive Food Intake Disorder
RecruitingObservational study
Gut Microbiota Changes in Children Receiving Exclusive Enteral Nutrition With Compleat® Paediatric
Feeding and Eating Disorders of Childhood, Enteral Nutrition Dependence
Not yet recruitingObservational study
Exploring Lived Experiences of Families of Children With Spinal Muscular Atrophy(SMA) Type 1 Regarding Feeding and Communication
Spinal Muscular Atrophy 1
Enrolling by invitationObservational study
CHAMP App Feeding Difficulties Repository
Feeding and Eating Disorders of Childhood, Gastrostomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding and Eating Disorders of Childhood, run by Meyer Children's Hospital IRCCS at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
K-SADS-PL (Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version) questionnaire (time frame: Immediately after the end of the study (last subject who will complete the qestionnaire)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.