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

Recruiting

• Conditions: Eating Disorders
• Interventions: Behavioral: Family-based treatment

• Registration Number: NCT05956366
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

Brief 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.

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 Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2035-12-31
• Study Completion: 2037-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• begin treatment for eating disorder

Exclusion Criteria

• lack of informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Other eating disorders	Family-based treatment	Children and adolescents presenting for treatment for other eating disorders (ICD-10: F50.8)
Anorexia nervosa	Family-based treatment	Children and adolescents presenting for treatment for anorexia nervosa typica or atypica (ICD-10: F50.0 or F50.1)
Bulimia nervosa	Family-based treatment	Children and adolescents presenting for treatment for bulimia nervosa typica or atypica (ICD-10: F50.2 or F50.3)

Primary Outcome Measures

Name	Time	Method
proportion of participants with absence of eating disordered behaviors	10 years after treatment completion	absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).
proportion of participants with weight normalisation	10 years after treatment completion	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

Trial Locations

Locations (1)

Child and Adolescent Mental Health Care Center; 🇩🇰 Copenhagen, Denmark