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临床试验/NCT05956366
NCT05956366招募中不适用

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

Mental Health Services in the Capital Region, Denmark1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
proportion of participants with absence of eating disordered behaviors

研究概览

简要总结

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.

详细描述

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?

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • begin treatment for eating disorder

排除标准

  • lack of informed consent

结局指标

主要结局

proportion of participants with absence of eating disordered behaviors

时间窗: 10 years after treatment completion

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

proportion of participants with weight normalisation

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Mental Health Services in the Capital Region, Denmark
申办方类型
Other
责任方
Sponsor

研究点 (1)

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