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临床试验/NCT05829408
NCT05829408招募中不适用

KOPPeling: Help From Your Own Circle

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2024年4月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
128
试验地点
1
主要终点
Change in Quality of Life (QoL) of COPMI

研究概览

简要总结

The goal of this randomized clinical trial is to test the effectiveness of the KOPPeling intervention that aims at unburdening COPMI (Children Of Parents with a Mental Illness). COPMI are at risk of overtaking the tasks of their parents when their parents are unable to fulfil such due to their psychiatric condition. By overtaking tasks and the urge to always take care of their parents, COPMI often do not participate in outdoor activities, which are necessary for their socio-emotional development. Moreover, insufficient socio-emotional development and parentification are risk factors for the development of psychiatric conditions.

KOPPeling is an intervention for COPMI families that focuses on activating the social networks of the families. Within KOPPeling, a strategic plan will be developed and carried out with the goal of receiving support from the social network that will overtake tasks of the family to unburden COPMI.

This study aims to answer the following questions:

  1. To what extent does KOPPeling lead to an increase in Quality of Life (QoL) among COPMI?
  2. To what extent does KOPPeling lead to an increase in mental health among COPMI?
  3. To what extent does KOPPeling lead to a reduction of parenting stress among COPMI parents?
  4. To what extent does KOPPeling lead to an increase in outdoor activities among COPMI?
  5. How does KOPPeling affect the feelings of guilt of COPMI when engaging in outdoor activities?
  6. What pre-conditions are needed to make KOPPeling widely applicable?
  7. What are the long-term effects of KOPPeling on the QoL and psychological problems among COPMI and parental stress among COPMI parents?

Participants will participate in the ten-to-twelve-week long KOPPeling intervention. Researchers will compare the intervention group with a waiting list control group to test the effect of KOPPeling on the QoL and mental health of COPMI and parental stress of parents.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • The family has children aged 0-18 living at home
  • The parental disorder influences the parent's (or parents') ability to carry out several important parental tasks, placing their offspring at risk of taking over these tasks

排除标准

  • The family has no existing social network

结局指标

主要结局

Change in Quality of Life (QoL) of COPMI

时间窗: At T0 (baseline, start of intervention), T1 (end of intervention) and T2 (three months after the end of intervention), total time frame: 22 to 24 weeks

QoL of COPMI, which will be assessed with the KIDSCREEN-27. The KIDSCREEN-27 includes 27 items measuring five dimensions of QoL on a Rasch scale including: 1) physical well-being, 2) psychological well-being, 3) autonomy and parent relation, 4) peers and social support, and 5) school environments. Each item is measured on a five-point Likert scale. Some items are negatively formulated through which the item scores need to be reversed. The overall score is calculated by summing up all the items. Therefore, higher scores indicate higher QoL.

次要结局

  • Change in mental health of COPMI(At T0 (baseline, start of intervention), T1 (end of intervention) and T2 (three months after the end of intervention), total time frame: 22 to 24 weeks)
  • Change in parental stress of COPMI parents(At T0 (baseline, start of intervention), T1 (end of intervention) and T2 (three months after the end of intervention), total time frame: 22 to 24 weeks)
  • Experiences of the social networks made with KOPPeling(At the end of the intervention (ten to twelve weeks after the start of the intervention))
  • Change in engagement in outdoor activities of COPMI(For one week after the start of the intervention and one week before the end of the intervention)
  • Change in guilt of COPMI when engaging in outdoor activities(For one week after the start of the intervention and one week before the end of the intervention)
  • Promoting and hindering factors of making KOPPeling a widely applicable intervention(At the end of the intervention (ten to twelve weeks after the start of the intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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