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临床试验/NCT06792227
NCT06792227Enrolling By Invitation不适用

Family-based Treatment At Home in Adolescents with Eating Disorders and Co-occurring Mental Health Conditions

Karakter Kinder- en Jeugdpsychiatrie2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
10
试验地点
2
主要终点
Weight

研究概览

简要总结

The significant impact of eating disorders on adolescents necessitates the evaluation of current treatments. Family-based Treatment (FBT) is the standard treatment but has modest remission rates, highlighting the need for improvements. Assessing its effectiveness in adolescents with co-occurring mental health conditions is also crucial. In the Netherlands, there is a growing focus on home-based treatment. This study aims to enhance remission rates in FBT by adapting it for use in a home setting (FBT-H).

详细描述

Background:

The significant impact of eating disorders on adolescents necessitates the evaluation of current treatments. Family-based Treatment (FBT) is the standard treatment but has modest remission rates, highlighting the need for improvements. Assessing its effectiveness in adolescents with co-occurring mental health conditions is also crucial. In the Netherlands, there is a growing focus on home-based treatment. This study aims to enhance remission rates in FBT by adapting it for use in a home setting (FBT-H).

Objective:

This mixed-method study combines single case studies with qualitative research. The primary objective is to assess the effects and experiences of FBT-H in adolescents with eating disorders and co-occurring mental health conditions across variables such as weight, eating disorder symptoms, anxiety, mood, well-being, quality of life, and family dynamics. Additionally, it explores the experiences of adolescents, parents, and practitioners with FBT-H.

Methods:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • adolescents aged 12 to 18 years;
  • meeting the criteria for AN or other specified feeding or eating disorder (OSFED);
  • presence of co-occurring mental health conditions;
  • sufficient command of the Dutch language by adolescents and parents;
  • the family supports the treatment as a supportive system and is open to participating in the research.

排除标准

  • acute suicidal behaviour requiring hospitalization within the 4 weeks prior to assessment for this study;
  • cognitive limitations (IQ < 70);
  • participation of a sibling in the current study (to prevent transfer of therapy effects between siblings);
  • the adolescent does not receive tube feeding at the start of FBT-H and/or is not hospitalized due to an eating disorder at the start of treatment.

结局指标

主要结局

Weight

时间窗: Each session (week 1 - week 52, through study completion)

Weight - each session The weight of the adolescent in kilograms (kg) is measured weekly to monitor progress. The weight is measured by an FBT-H practitioner in an FBT-H session. The weight is measured in the same way every week (e.g., in underwear). This is a standard measurement associated with the FBT intervention and takes approximately 5 minutes.

次要结局

  • Outcome Rating Scale(Each session (week 1 - week 52, through study completion))
  • Session Outcome Rating Scale(Each session (week 1 - week 52, through study completion))
  • Eating Disorder Examination Questionnaire(Adolescents in this study will complete the EDE-Q five times (T0 to T4)(T0 = Week 0, T1 = month 3, T2 = month 6, T3 = month 9, T4 = month 12) . It takes 10 minutes to complete the questionnaire.)
  • Quality of Life(Adolescents and their parents are asked to complete this questionnaire five times (T0 to T4)(T0 = Week 0, T1 = month 3, T2 = month 6, T3 = month 9, T4 = month 12) and it requires 10 minutes to complete.)
  • Parent-Child Interaction Questionnaire-Revised(The OKIV-R is administered a total of five times to both adolescents and their parents (T0 to T4)(T0 = Week 0, T1 = month 3, T2 = month 6, T3 = month 9, T4 = month 12) . The duration to complete the questionnaire is approximately10 minutes.)
  • Parenting Burden Questionnaire (Opvoedingsbelasting Vragenlijst (OBVL)(The OBVL is administered a total of five times to parents participating in this study (T0 to T4)(T0 = Week 0, T1 = month 3, T2 = month 6, T3 = month 9, T4 = month 12) , and it requires 15 minutes of their time.)

研究者

发起方
Karakter Kinder- en Jeugdpsychiatrie
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rik Knipschild

PhD

Karakter Kinder- en Jeugdpsychiatrie

研究点 (2)

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