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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-17
SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

begin treatment for eating disorder

Disqualifiers

lack of informed consent

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Family-based treatment

    Behavioral

    Open-end family therapy ad modum The Maudsley model

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Anorexia nervosa1 intervention
Group B: Bulimia nervosa1 intervention
Group C: Other eating disorders1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
through treatment completion an average of 1 year
2

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

Time frame
2.5 years after treatment completion
3

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

Time frame
5 years after treatment completion
4

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

Time frame
7.5 years after treatment completion

Secondary outcomes

Other outcomes

Sponsors and contacts

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