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父母有受抚养子女或孩子重病时的家庭谈话干预

2026年9月18日 更新者:Malin Lövgren、Ersta Sköndal University College

有受抚养子女或重病的父母在临床实践中的家庭谈话干预:一项有效性实施研究

The overall aim of this study is to evaluate the effects and the implementation process of the Family Talk Intervention (FTI) in clinical practice when a child or a parent of dependent children has a life-threatening/life-limiting illness (cancer, neurological diseases, etc.). During 2021, FTI will be implemented in several different care contexts including a children's hospital and a university hospital in Sweden. Social workers will be educated in using the FTI in their clinical work. This study has a pre-post effectiveness-implementation hybrid design using mixed method. Data collection will be made using web-based questionnaires and interviews with families and social workers, and observations will be performed throughout the study.

研究概览

地位

完全的

条件

详细说明

The Family Talk Intervention (FTI), also called Beardslee's Family Intervention is a manual-based complex intervention and involves families who have children aged 6-18 years. The core elements are to support the families in talking about illness-related subjects, support the parents in understanding the needs of their children and how to support them, and support the families in identifying their strengths and how best to use them.

The overall aim of this trial is to evaluate the effects and the implementation process of FTI in clinical practice when a parent or a child has a life-threatening/life-limiting illness (cancer, neurological diseases, etc.). More specifically, to examine the effects of FTI regarding family communication and psychosocial health among family members (Aim 1) and describe facilitating factors and barriers for implementing FTI in everyday clinical practice (Aim 2).

The FTI has previously been pilot-tested in the context of specialized palliative home care with promising results. In pilot-tests, an assigned interventionist was used for intervention delivery, while in this continued trial, social workers will deliver the intervention as a part of their clinical work.

This trial has a pre-post effectiveness-implementation hybrid design using mixed method. It will be placed at a children's hospital and at a university hospital in Sweden and conducted by all social workers working there (n=25). Education of social workers in working with FTI will take place during 2021 and families will be invited to the project from April 2022 and until power has been reached. Data will be collected using web-based questionnaires and interviews with families and social workers, and observations will be performed throughout the study.

研究类型

介入性

注册 (实际的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Stockholm、瑞典、SE- 10061
        • Marie Cederschiöld University College

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Families that include a child with a life-threatening/life-limiting illness.
  • 2-3 months should have passed since diagnosis or relapse.
  • <2 members of the family need to participate

Exclusion Criteria:

-

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Family Talk intervention

FTI entails six meetings, with intervals of 1-2 weeks between meetings. Meetings 1-2 include only the parent(s) and focus on their experiences of the situation, as well as the consequences of the diagnosis for each family member. The parent(s) will formulate the goal of the intervention. Meeting 3: Interviews will be held with each child and includes the child's life situation. Meeting 4 includes the parent(s) and focuses on planning the family meeting. The children's thoughts and questions serve as a guide for the upcoming family meeting. Meeting 5 is a family meeting and consists of questions and issues raised earlier by the family members. Meeting 6 is a follow-up with all family members. The meeting is guided by the family members' needs, e.g., regarding communication and parenting. If the intervention is interrupted unexpectedly and cannot be finished as scheduled due to extraordinary circumstances, extra meetings are available (Meetings 7-11).

A psychosocial family-based intervention that is designed to give support to an entire family when a child has life-threatening illness.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Changed family communication from Family Adaptability and Cohesion Scale IV (FACES IV)
大体时间:At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).

Measures family communication

At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).

次要结果测量

结果测量
措施说明
大体时间
Changed resilience for adults measured by the Resilience Scale (RS-14)
大体时间:At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).

Measures psychosocial health for parents/guardians and for children aged 13 years and older

At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Changed resilience in children measured by the Resilience Scale for Children (RS-10),
大体时间:At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).

Measures psychosocial health for children aged 8-12 years

At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Changed symptoms of pathologic grief measured by Prolonged Grief Disorder (PG-12)
大体时间:At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).

Measures pre-death grief

At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Generalized Anxiety Disorder (GAD)
大体时间:At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).

Measures anxiety in adults

At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Changed feelings of strength and weaknesses in children measured by The Strengths and Difficulties Questionnaire (SDQ)
大体时间:At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).

Measures self-perceived strength and weakness. Parent Proxy for children under 11 years.

At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Changed feelings of parental skill measured by the Parental Skill Questionnaire (SDQ)
大体时间:At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).

Measures self-perceived parental skill

At baseline (before FTI starts), after the end of FTI/three months later (follow-up 1), and six months after that (follow-up 2).
Changed key mechanisms to promote and inhibit implementation measured by The Swedish Normalization Process Theory Measure (S-NoMAD)
大体时间:At baseline (after FTI education), four months later (follow-up 1) and 12 months later (follow-up 2).

Characterizes and explains key mechanisms that promote and inhibit the implementation, embedding and integration of new health techniques, technologies and other complex interventions.

At baseline (after FTI education), four months later (follow-up 1) and 12 months later (follow-up 2).
Changed organizational context measured by Alberta Context Tool (ACT)
大体时间:At baseline (after FTI education), four months later (follow-up 1) and 12 months later (follow-up 2).

Measures organizational context for use in complex healthcare settings.

At baseline (after FTI education), four months later (follow-up 1) and 12 months later (follow-up 2).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Malin Lövgren, PhD、Ersta Sköndal Bräcke University College

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年2月1日

初级完成 (实际的)

2025年8月30日

研究完成 (实际的)

2025年8月31日

研究注册日期

首次提交

2021年5月11日

首先提交符合 QC 标准的

2021年8月18日

首次发布 (实际的)

2021年8月25日

研究记录更新

最后更新发布 (实际的)

2026年9月23日

上次提交的符合 QC 标准的更新

2026年9月18日

最后验证

2025年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • Marie Cederschiöld

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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