The SOFUS Psychological Intervention for Families With Children in Pediatric Palliative Care - a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Satisfaction assessed by questionnaire items constructed for this study
研究概览
简要总结
Families of children receiving pediatric palliative care report unmet needs that require support. The objective of this pilot study is to develop and evaluate a psychological intervention (SOFUS) that targets the whole family (i.e. parents, the ill child and siblings) before and after bereavement. The aim of the intervention is to improve coping skills and reduce symptoms of complicated grief, depression, anxiety and sleep disorders in families. Feasibility and acceptability of the intervention manual and study materials will be evaluated, and the preliminary efficacy of the intervention will be assessed.
详细描述
Having a child in palliative care is a traumatic experience and families of children receiving pediatric palliative care report unmet needs that require support. Parents who experience the death of a child often experience severe grief reactions, which may develop into long-term impaired functioning or psychiatric illness, with a detrimental impact on the whole family. Furthermore, parents and siblings of a child in palliative care may already prior to death experience grief and loss. This indicates the need for a family-based intervention that can support the family before and after the death of a child.
SOFUS is a psychological intervention for families of children receiving pediatric palliative care team. The preliminary/pilot program has been manualized and consists of a pre-loss program (Program 1) and a post-loss program (Program 2) consisting of six sessions each designed for the whole family. Sessions 1 and 6 includes the whole family, sessions 2 and 3 focus on the parents, while sessions 4 and 5 target the children (with parents if the child is under 10 years old). The six sessions range from 1 to 1.5 hours in length and are to be delivered over a 3 month period. The intervention will be carried out by trained psychologists. Feasibility and fidelity will assessed by evaluation forms filled out by the therapist after each session.
At the end of the intervention, semi-structured interviews will be carried out with each family to evaluate the components of the intervention, participant materials and assess acceptability. A semi-structured interview will also be carried out with the psychologists to evaluate the components of the intervention, the intervention manual and to assess therapist acceptability of the intervention. This pilot study will also include questionnaires for the parents assessing the outcomes of coping, anxiety, depression, sleep quality, family functioning and family caregiving burden at baseline, 3, 6 and 12 months. Age-adapted questionnaires will be given to the children to assess a subset of the outcomes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents of a child age between 6 months and 18 years referred to the palliative team for children and adolescents
- •At least one parent > 18 years
- •Able to understand and speak Danish wish to participate
- •Informed consent by at least one parent, and by both parents on behalf of any children participating
排除标准
- •Any untreated psychiatric disorder or substance abuse in the family that may hinder participation in the program
研究组 & 干预措施
SOFUS pilot program
干预措施: SOFUS pilot program (Behavioral)
结局指标
主要结局
Satisfaction assessed by questionnaire items constructed for this study
时间窗: Post-intervention (3 months)
Measured by 9 study-specific items assessing parental satisfaction with the intervention's materials, the therapist and the intervention's focus on family/child-related factors; score range 0-27; higher scores = higher satisfaction
Satisfaction assessed by interview items constructed for this study
时间窗: Post-intervention (3 months)
Assessed through open-ended interview items evaluating the family's satisfaction with the following: 1) motivation and barriers to participation, 2) format of the intervention, 3) video and written materials of the intervention, and 4) intervention components related to the children.
Feasibility assessed by questionnaire items constructed for this study
时间窗: After each session
Measured by items assessing whether the therapist carried out each section of the manualized session and whether the time allotted was sufficient. Section scores range from 0-12, with higher scores indicating higher feasibility.
Feasibility assessed by interview items constructed for this study
时间窗: Post-intervention (3 months)
Assessed through open-ended interview items evaluating the the following: 1) recruitment procedures, 2) format of the intervention, 3) focus areas of intervention, 4) the intervention manual, and 5) the intervention materials for the families.
次要结局
- Change in coping strategies in parents and children above 12 years(Between baseline and 3 months, 6 months, 12 months, respectively)
- Change in coping strategies in children 6-12 years old(Between baseline and 3 months, 6 months, 12 months, respectively)
- Change in symptoms of grief in parents and children above 12 years(Between baseline and 3 months, 6 months, 12 months, respectively)
- Change in symptoms of anxiety in parents and children above 12 years(Between baseline and 3 months, 6 months, 12 months, respectively)
- Change in symptoms of depression in parents and children above 12(Between baseline and 3 months, 6 months, 12 months, respectively)
- Change in symptoms of depression in children 2-5 years old(Between baseline and 3 months, 6 months, 12 months, respectively)
- Change in symptoms of depression in children 6-12 years old(Between baseline and 3 months, 6 months, 12 months, respectively)
- Change in sleep quality in parents only(Between baseline and 3 months, 6 months, 12 months, respectively)
- Change in emotion regulation in parents(Between baseline and 3 months, 6 months, 12 months, respectively)
- Change in emotion regulation in children(Between baseline and 3 months, 6 months, 12 months, respectively)
- Change in family functioning in parents and children above 12 years(Between baseline and 3 months, 6 months, 12 months, respectively)
- Change in family caregiving burden in parents only(Between baseline and 3 months, 6 months, 12 months, respectively)
研究者
Pernille Bidstrup
Senior researcher and group leader
Danish Cancer Society