Effectiveness of Family-based Intervention for Youn Persons With Eating Disorders (VIBUS-wp1)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Eating Disorders
• Intervention / Treatment: Behavioral: Family-based treatment

Detailed 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?

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Mette Bentz, PhD; Phone Number: +45 38 64 10 35; Email: mette.bentz@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, DK-2400
    • Recruiting
    • Child and Adolescent Mental Health Care Center
    • Contact: Mette Bentz, PhD; Phone Number: +45 38 64 10 35; Email: mette.bentz@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients assessed and treated for any eating disorder (ICD-10: F50.0-F50.8) in the unit for treatment of eating disorders will be invited to participate.

Due to the naturalistic design of this study we will examine a representative, consecutive sample, without any exclusion criteria except the absence of informed consent by patient and parents or legal care takers.

Description

Inclusion Criteria:

• begin treatment for eating disorder

Exclusion Criteria:

• lack of informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anorexia nervosa; Children and adolescents presenting for treatment for anorexia nervosa typica or atypica (ICD-10: F50.0 or F50.1)	Behavioral: Family-based treatment; Open-end family therapy ad modum The Maudsley model; Other Names: FBT
Bulimia nervosa; Children and adolescents presenting for treatment for bulimia nervosa typica or atypica (ICD-10: F50.2 or F50.3)	Behavioral: Family-based treatment; Open-end family therapy ad modum The Maudsley model; Other Names: FBT
Other eating disorders; Children and adolescents presenting for treatment for other eating disorders (ICD-10: F50.8)	Behavioral: Family-based treatment; Open-end family therapy ad modum The Maudsley model; Other Names: FBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Investigators: Principal Investigator: Mette Bentz, PhD, Child and Adolescent Mental Health Care Centre, Capital Region of Denmark; Study Director: Anne Katrine Pagsberg, professor, Child and Adolescent Mental Health Care Centre, Capital Region of Denmark

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2037

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: eating disorders, adolescents
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: H-17022391

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