VIBUS-wp1: Effectiveness of Family-based Intervention in a Child and Adolescent Mental Health Service (CAMHS) for Children and Adolescents With Eating Disorders

Sponsor
Mental Health Services in the Capital Region, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT05956366
Collaborator
(none)
1,000
1
237
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Family-based treatment

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effectiveness of Family-based Intervention in a Child and Adolescent Mental Health Service for Children and Adolescents With Eating Disorders
Actual Study Start Date :
Apr 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2035
Anticipated Study Completion Date :
Dec 31, 2037

Arms and Interventions

Arm Intervention/Treatment
Anorexia nervosa

Children and adolescents presenting for treatment for anorexia nervosa typica or atypica (ICD-10: F50.0 or F50.1)

Behavioral: Family-based treatment
Open-end family therapy ad modum The Maudsley model
Other Names:
  • FBT
  • Bulimia nervosa

    Children and adolescents presenting for treatment for bulimia nervosa typica or atypica (ICD-10: F50.2 or F50.3)

    Behavioral: Family-based treatment
    Open-end family therapy ad modum The Maudsley model
    Other Names:
  • FBT
  • Other eating disorders

    Children and adolescents presenting for treatment for other eating disorders (ICD-10: F50.8)

    Behavioral: Family-based treatment
    Open-end family therapy ad modum The Maudsley model
    Other Names:
  • FBT
  • Outcome Measures

    Primary Outcome Measures

    1. proportion of participants with weight normalisation [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 [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 [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 [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 [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 [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 [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 [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 [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 [10 years after treatment completion]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • begin treatment for eating disorder
    Exclusion Criteria:
    • lack of informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Child and Adolescent Mental Health Care Center Copenhagen Denmark DK-2400

    Sponsors and Collaborators

    • Mental Health Services in the Capital Region, Denmark

    Investigators

    • Principal Investigator: Mette Bentz, PhD, Child and Adolescent Mental Health Care Centre, Capital Region of Denmark
    • Study Director: Anne Katrine Pagsberg, professor, Child and Adolescent Mental Health Care Centre, Capital Region of Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mental Health Services in the Capital Region, Denmark
    ClinicalTrials.gov Identifier:
    NCT05956366
    Other Study ID Numbers:
    • H-17022391
    First Posted:
    Jul 21, 2023
    Last Update Posted:
    Jul 21, 2023
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mental Health Services in the Capital Region, Denmark
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 21, 2023