Clinical trial NCT05956366: Effectiveness of Family-based Intervention for Youn Persons With Eating Disorders
Official title: Effectiveness of Family-based Intervention in a Child and Adolescent Mental Health Service for Children and Adolescents With Eating Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eating Disorders
Keywords: eating disorders, adolescents
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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?

Eligibility criteria: Inclusion Criteria:

* begin treatment for eating disorder

Exclusion Criteria:

* lack of informed consent

Primary outcomes:
measure: proportion of participants with weight normalisation
timeFrame: through treatment completion an average of 1 year
measure: proportion of participants with weight normalisation
timeFrame: 2.5 years after treatment completion
measure: proportion of participants with weight normalisation
timeFrame: 5 years after treatment completion
measure: proportion of participants with weight normalisation
timeFrame: 7.5 years after treatment completion
measure: proportion of participants with weight normalisation
timeFrame: 10 years after treatment completion
measure: proportion of participants with absence of eating disordered behaviors
timeFrame: through treatment completion an average of 1 year
measure: proportion of participants with absence of eating disordered behaviors
timeFrame: 2.5 years after treatment completion
measure: proportion of participants with absence of eating disordered behaviors
timeFrame: 5 years after treatment completion
measure: proportion of participants with absence of eating disordered behaviors
timeFrame: 7.5 years after treatment completion
measure: proportion of participants with absence of eating disordered behaviors
timeFrame: 10 years after treatment completion
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Child and Adolescent Mental Health Care Center
Study officials:
affiliation: Child and Adolescent Mental Health Care Centre, Capital Region of Denmark
name: Mette Bentz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Child and Adolescent Mental Health Care Centre, Capital Region of Denmark
name: Anne Katrine Pagsberg, professor
role: STUDY_DIRECTOR
References: