The Family Talk Intervention in Clinical Practice When a Parent With Dependent Children or a Child is Severely Ill: An Effectiveness-implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Changed family communication from Family Adaptability and Cohesion Scale IV (FACES IV)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Changed family communication from Family Adaptability and Cohesion Scale IV (FACES IV)
时间窗: 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
次要结局
- Changed organizational context measured by Alberta Context Tool (ACT)(At baseline (after FTI education), four months later (follow-up 1) and 12 months later (follow-up 2).)
- Changed symptoms of pathologic grief measured by Prolonged Grief Disorder (PG-12)(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)(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),(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 for adults measured by the Resilience Scale (RS-14)(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)(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)(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)(At baseline (after FTI education), four months later (follow-up 1) and 12 months later (follow-up 2).)
研究者
Malin Lövgren
Associate professor
Ersta Sköndal University College