Effectiveness of Family-based Intervention for Youn Persons With Eating Disorders

Eating Disorders Clinical Trial

— VIBUS-wp1  

Official title:

Effectiveness of Family-based Intervention in a Child and Adolescent Mental Health Service for Children and Adolescents With Eating Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05956366
• Other study ID #: H-17022391
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: December 31, 2037

Study information

• Verified date: March 2024
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Mette Bentz, PhD
• Phone: +45 38 64 10 35
• Email: mette.bentz[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This research project aims to characterize a naturalistic cohort of children and adolescents with eating disorders in terms of biological, psychological and psychopathological features. Further, the project will examine the effectiveness of treatment, the determinants of treatment outcome and the course of treatment response for children and adolescents with eating disorders (ED), treated in a generic specialist child and adolescent mental health service. The first choice of treatment is outpatient family-based treatment (FBT), which has documented effect for anorexia nervosa and bulimia nervosa. However, a subgroup of young persons with eating disorders does not respond sufficiently to this treatment, and evidence concerning effective treatment for children and adolescents with atypical eating disorders is still lacking. Further, treatment effectiveness for children and adolescents in a Danish naturalistic setting has never been examined.

Description:

The overall aim is to assess associations between patient characteristics and treatment response across the spectrum of eating disorders to identify, which patients benefit from family based treatment, and which patients possibly would need other kinds of treatment or more intensive care.

Research questions:

1. Which patient and family characteristics predict faster recovery from ED in childhood and adolescence?

2. Which patient and family characteristics predict intensification of treatment in the forms of day hospital or full hospitalization?

3. At which time point can recovery be predicted based on information from initial assessment and/or assessment during the course of treatment?

4. Which patient and family characteristics (e.g. patterns of comorbid symptoms) are common in those not responding well to treatment within each diagnostic category?

5. How many young patients migrate between ED diagnoses, and what characterizes these patients?

6. Studies on treatment effectiveness for EDNOS in children and adolescents are still lacking. Hence, an important research question of this study is whether family based treatment for EDNOS is effective and is perceived as helpful by patients and families?

In addition, the project will seek to answer the following:

7. Is treatment effectiveness in The Capital Region of Denmark (BUC) comparable to published results from other countries in the same age group?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2037
• Est. primary completion date: December 31, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• begin treatment for eating disorder

Exclusion Criteria:

• lack of informed consent

Related Conditions & MeSH terms

• Eating Disorders
• Feeding and Eating Disorders

Intervention

Behavioral:
• Family-based treatment
Open-end family therapy ad modum The Maudsley model

Locations

Country	Name	City	State
Denmark	Child and Adolescent Mental Health Care Center	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of participants with weight normalisation	at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents	through treatment completion an average of 1 year
Primary	proportion of participants with weight normalisation	at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents	2.5 years after treatment completion
Primary	proportion of participants with weight normalisation	at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents	5 years after treatment completion
Primary	proportion of participants with weight normalisation	at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents	7.5 years after treatment completion
Primary	proportion of participants with weight normalisation	at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents	10 years after treatment completion
Primary	proportion of participants with absence of eating disordered behaviors	absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).	through treatment completion an average of 1 year
Primary	proportion of participants with absence of eating disordered behaviors	absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).	2.5 years after treatment completion
Primary	proportion of participants with absence of eating disordered behaviors	absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).	5 years after treatment completion
Primary	proportion of participants with absence of eating disordered behaviors	absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).	7.5 years after treatment completion
Primary	proportion of participants with absence of eating disordered behaviors	absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).	10 years after treatment completion