跳至主要内容
临床试验/NCT05365919
NCT05365919招募中不适用

The Family Talk Intervention in Clinical Practice When a Parent With Dependent Children is Severely Ill: An Effectiveness-implementation Study

Ersta Sköndal University College1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Changes in family Communication over time. Family Adaptability and Cohesion Scale IV

研究概览

简要总结

This intervention study aims to evaluate a psychosocial family based intervention in clinical practice, the Family Talk Intervention (FTI), for families with dependent children affected by life-threatening/life-limiting illness, when a parent is ill.

The study has an effectiveness implementation hybrid design where both the effects of FTI and the implementation process in clinical practice are examined.

详细描述

When a family with dependent children is affected by severe illness this affects the entire family. Still, there is little research evaluating support to such families. This intervention study aims to evaluate a psychosocial family based intervention in clinical practice, the Family Talk Intervention (FTI), for families with dependent children affected by life-threatening/life-limiting illness, when a parent is ill.

The study has an effectiveness implementation hybrid design where both the effects of FTI and the implementation process in clinical practice are examined. FTI will be carried out as a cluster randomized trial at 12 clinics in specialized palliative homecare (6 units=intervention, 6 units=control).

All social workers at these clinics will receive education and training in FTI in 2021. From 2022, FTI will be offered to families cared for at these care contexts.

FTI is manual-based and consists of 6 meetings with the families (together and individually) and is led by the FTI-educated social workers. The aim of FTI are to support the family in talking about illness-related subjects (e.g. prognosis, stress), support parenting, and support the family in identifying their strengths and how to best use them.

FTI will be evaluated through surveys and interviews with families before FTI/baseline and after completed intervention (3 and 6 months after baseline). Further, social workers will be invited to compete questionnaires and take part in focus groups about their experiences of FTI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Families affected by a life-threatening or life-limiting illness and have dependent children, ill or health aged 0-19 years and
  • Enrolled in specialized palliative home care
  • At least two family members have accepted to participate

排除标准

  • 未提供

研究组 & 干预措施

Standard support

No Intervention

The control group will receive standard support

Intervention

Experimental

The intervention group will be offered to participate in the Family Talk Intervention

干预措施: Family Talk Intervention (Other)

结局指标

主要结局

Changes in family Communication over time. Family Adaptability and Cohesion Scale IV

时间窗: Six months

Measures in self-rated family communication which is the primary outcome of the intervention

次要结局

  • Changes in factors needed for successful implementation.The Swedish Normalization Process Theory Measure (S-NoMAD)(Six months)
  • Changes in self-rated resilience. Resilience Scale (RS-14) ((Resilience Scale for Children (RS-10)).(Six months)
  • Changes in self-rated anxiety. Generalized Anxiety Disorder (GAD)(Six months)
  • Changes in perception of organizational context. Alberta Context Tool (ACT)(Six months)
  • Changes in self-rated grief. Prolonged Grief Disorder (PG-12/PG-13).(Six months)
  • Changes in The Strengths and Difficulties Questionnaire (SDQ)(Six months)
  • Changes in self-perceived parenting skill. Parental Skills Checklist (PSC)(Six months)

研究者

发起方
Ersta Sköndal University College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Malin Lövgren

Associate professor

Ersta Sköndal University College

研究点 (1)

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