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Recruiting NCT05956366

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

Observational Eating Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Family-based treatment.
Who it may be relevant to
Registry conditions: Eating Disorders. Basic parameters: 7 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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?

Interventions

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

Primary outcome measures

  • proportion of participants with weight normalisation [Time frame: through treatment completion an average of 1 year]
  • proportion of participants with weight normalisation [Time frame: 2.5 years after treatment completion]
  • proportion of participants with weight normalisation [Time frame: 5 years after treatment completion]
  • proportion of participants with weight normalisation [Time frame: 7.5 years after treatment completion]
  • proportion of participants with weight normalisation [Time frame: 10 years after treatment completion]
  • proportion of participants with absence of eating disordered behaviors [Time frame: through treatment completion an average of 1 year]
  • proportion of participants with absence of eating disordered behaviors [Time frame: 2.5 years after treatment completion]
  • proportion of participants with absence of eating disordered behaviors [Time frame: 5 years after treatment completion]
  • proportion of participants with absence of eating disordered behaviors [Time frame: 7.5 years after treatment completion]
  • proportion of participants with absence of eating disordered behaviors [Time frame: 10 years after treatment completion]

Eligibility criteria

Inclusion criteria

  • begin treatment for eating disorder

Exclusion criteria

  • lack of informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Child and Adolescent Mental Health Care Center — Copenhagen

Publications

  • Bentz M, Pedersen SH, Moslet U, Petersen N, Pagsberg AK. Predictors of response to family-based treatment for anorexia nervosa in youth: insights from the VIBUS project. Eur Child Adolesc Psychiatry. 2025 Nov;34(11):3665-3684. doi: 10.1007/s00787-025-02766-x. Epub 2025 Jun 11. PMID 40498327

Identifiers

NCT: NCT05956366 · H-17022391

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗