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NCT Number: NCT05956366

Effectiveness of Family-based Intervention for Youn Persons 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.

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Key information

Conditions

Eating Disorders Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Child and Adolescent Mental Health Care Center

Copenhagen, DK-2400, Denmark

Location status: Recruiting

Location contact

Mette Bentz, PhD

CONTACT

[email protected]

+45 38 64 10 35

About this study

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:

  • Which patient and family characteristics predict faster recovery from ED in childhood and adolescence?
  • Which patient and family characteristics predict intensification of treatment in the forms of day hospital or full hospitalization?
  • At which time point can recovery be predicted based on information from initial assessment and/or assessment during the course of treatment?
  • Which patient and family characteristics (e.g. patterns of comorbid symptoms) are common in those not responding well to treatment within each diagnostic category?
  • How many young patients migrate between ED diagnoses, and what characterizes these patients?
  • 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:

  • Is treatment effectiveness in The Capital Region of Denmark (BUC) comparable to published results from other countries in the same age group?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • begin treatment for eating disorder

Exclusion criteria

  • lack of informed consent

Treatment and study plan

Family-based treatment

Behavioral

Open-end family therapy ad modum The Maudsley model

Other names: FBT

Primary outcomes

  1. proportion of participants with weight normalisation

    Time frame: through treatment completion an average of 1 year

    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. proportion of participants with weight normalisation

    Time frame: 2.5 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

  3. proportion of participants with weight normalisation

    Time frame: 5 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

  4. proportion of participants with weight normalisation

    Time frame: 7.5 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

  5. proportion of participants with weight normalisation

    Time frame: 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

  6. proportion of participants with absence of eating disordered behaviors

    Time frame: through treatment completion an average of 1 year

    absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).

  7. proportion of participants with absence of eating disordered behaviors

    Time frame: 2.5 years after treatment completion

    absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).

  8. proportion of participants with absence of eating disordered behaviors

    Time frame: 5 years after treatment completion

    absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).

  9. proportion of participants with absence of eating disordered behaviors

    Time frame: 7.5 years after treatment completion

    absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).

  10. proportion of participants with absence of eating disordered behaviors

    Time frame: 10 years after treatment completion

    absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).

Study contacts

Contact information is provided by the study sponsor or research team.

Mette Bentz, PhD

CONTACT

[email protected]

+45 38 64 10 35

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Registry information

Official study title

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

Acronym: VIBUS-wp1

Important dates

Study start
2018
Primary completion
2035
Study completion
2037
First posted
Jul 21, 2023
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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