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临床试验/NCT04038242
NCT04038242已完成不适用

A Resilience Promotion Program for Parents of Children With Cancer

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2019年8月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
1
主要终点
Change in levels of resilience from baseline to 6-month follow-up between intervention and control group

研究概览

简要总结

Cancer is a leading cause of death for children. With the increasing incidence of childhood cancer, the mental health problems emerge in those parents struggle with their children's life-threatened disease. Caring for children with cancer is described as life-changing experience and overwhelming stress for parents. Many studies have been conducted to screen the psychological distress for these parents and found a considerable percentage of them suffering from depressive symptoms. Poorer quality of life was also found in parents of children with cancer when compared to parents of children without cancer. Additionally, parental distress interacted with children's emotions and could have detrimental effects on children's both physical and mental health. Therefore, it is important to take measures improving the mental health for parents of children with cancer.

Although current various psychological interventions illustrated small to moderate improvements of mental health for parents of children with cancer, the total effect base on a systematic review was not statistically significant. The purpose of these interventions was predominantly to treat negative mental health problems such as depression and no recognized effective psychological interventions were available for parents of children with cancer until now. Along with the paradigm shift from problem-oriented approach to nurturing strengths in the post-modern period, instead of exclusively treating mental health problems, researchers payed more attention to positive therapy such as resilience promotion program. Resilience usually refers to the ability to adapt adverse conditions and maintain positive status. Resilience studies are mounting since the flourishing of positive psychology movement and meaningful results were gained from corresponding intervention program concentrating on resilience promotion in adolescent education, handling chronic disease and recovery of breast cancer. However, there is a lack of targeted resilience promotion program for parents of children with cancer. The results of our pilot study showed low levels of resilience in parents of children with cancer and strong associations among parental resilience, quality of life and depression. It indicates that the increase in resilience can benefit for the mental health of parents. Therefore, a resilience promotion program will be conducted to examine efficacy for parents of children with cancer.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • having a child (0-19 years old) with cancer diagnosis.
  • Chinese resident and able to read Chinese and speak Mandarin.

排除标准

  • having physical impairment or cognitive and learning problems identified from family history of medical records.
  • attending other researches.

结局指标

主要结局

Change in levels of resilience from baseline to 6-month follow-up between intervention and control group

时间窗: 6-month follow-up

The primary outcome measure is the resilience of subjects at 6-month follow-up when compare to baseline. The Connor-Davison resilience scale will be used to assess participants' resilience. The total score ranges from 0-100 and higher score reflecting higher levels of resilience.

次要结局

  • Levels of stress at baseline(baseline)
  • Change in levels of stress from baseline to 6-month follow-up between intervention and control group(6-month follow-up)
  • Levels of resilience at baseline(baseline)
  • Change in levels of resilience from baseline to 2-month follow-up between intervention and control group(2-month follow-up)
  • Levels of quality of life at baseline(baseline)
  • Change in levels of quality of life from baseline to 2-month follow-up between intervention and control group(2-month follow-up)
  • Levels of depression at baseline(baseline)
  • Change in levels of quality of life from baseline to 6-month follow-up between intervention and control group(6-month follow-up)
  • Change in levels of depression from baseline to 2-month follow-up between intervention and control group(2-month follow-up)
  • Levels of anxiety at baseline(baseline)
  • Change in levels of depression from baseline to 6-month follow-up between intervention and control group(6-month follow-up)
  • Change in levels of anxiety from baseline to 2-month follow-up between intervention and control group(2-month follow-up)
  • Change in levels of stress from baseline to 2-month follow-up between intervention and control group(2-month follow-up)
  • Change in levels of anxiety from baseline to 6-month follow-up between intervention and control group(6-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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