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临床试验/NCT06097247
NCT06097247进行中(未招募)不适用

Family Functioning and Adverse Side Effects of Family-based Therapy for Anorexia Nervosa. User Perspectives and Observed Changes - a Mixed Method Explorative Study Designed to Inform a Clinical Trial Testing Treatment Improvements

Mental Health Services in the Capital Region, Denmark1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
The Systemic Clinical Outcome and Routine Evaluation - 15 items version (SCORE-15).

研究概览

简要总结

The study examines potential adverse side effects on family functioning and parent-child relationships of standard treatment family-based therapy (FBT) for anorexia nervosa (AN) in children and youths.

详细描述

Background:

Family-based treatment (FBT) for anorexia nervosa (AN) in children and youth has contributed significantly to the treatment of a disorder that has otherwise had a poor prognosis. Focus in FBT is on empowering parents to take full control over their child's nourishment. However, many parents are concerned how FBT might affect the relationship with their child as parents assume a double role of insisting on eating and weight gain, while at the same time providing emotional support, when this distresses the child. Moreover, FBT may have a "blind eye" to psychological difficulties with e.g. emotion regulation and interpersonal challenges, and thus inadvertently exacerbating them while focusing narrowly on eating and weight gain.

Aim:

The aim of the study is to quantitatively investigate side-effects of FBT by:

  1. Assessing average changes as well as variations across families from start of FBT, after 3 months, and at end of FBT in four domains: perceived parental stress level and family function, emotion regulation ability and perceived attachment to parents.
  2. Qualitatively describe the lived experience of young persons as well as parents going through FBT.
  3. Based on the results of a) and b) to generate hypotheses on which additions and / or alterations to treatment that may mitigate potential adverse side effects of FBT- treatment. These modifications to FBT will be tested in a future clinical trial.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of F50.0 or F50.1 first time of treatment with family-based treatment living with a minimum of one parent informed consent from young person and parents

排除标准

  • non Danish-speaking

结局指标

主要结局

The Systemic Clinical Outcome and Routine Evaluation - 15 items version (SCORE-15).

时间窗: Start and End of Treatment (an average of 1 year).

Minimum value: 1 Maximum value: 5 Higher scores mean worser outcome.

The Kerns Security Scale-Revised 21

时间窗: Start and End of Treatment (an average of 1 year).

Minimum value: 1 Maximum value: 4 Higher scores indicate more secure attachment.

Difficulties in Emotion Regulation Scale (DERS)

时间窗: Start and End of Treatment (an average of 1 year).

Minimum value: 1 Maximum value: 5 Higher scores mean worser outcome.

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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