Children Facing Parental Cancer : a Randomized Controlled Study Evaluating the Efficacy of a Psychological Intervention to Support Parenting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change of the communicational behavior
研究概览
简要总结
Background:
Cancer has a significant short and long-term impact on the family. Children of cancer patients may suffer from emotional, behavioral or somatic difficulties. Following the cancer diagnosis, many parents report being concerned about the impact of the illness on their children and how to communicate about the illness. In addition, they feel less able to meet the needs of their children and have difficulties regulating their emotions in response to their children's reactions.
Methods:
A randomized controlled trial was designed to assess the efficacy of a parental guidance intervention centered on communication with children in the context of a parental cancer.
This psychological intervention is designed to help parents and significant caregivers of the children. The participants are randomly assigned to either an intervention group (experimental group) or a waiting list group (control group).
The participants fill out self reported questionnaires that assess the parental self-efficacy in communication, mutual social support, communicational behaviors' with children, parenting concerns,communicational difficulties with children, knowledges about communication with children in oncological context, socio-demographical status, medical situation, psychiatric history, social difficulties and emotional state of the participants and children. The semi-structured interview with participants assesses their day to day communication with the children and the difficulties related to this communication. Those questionnaires are completed at baseline and post treatment (experimental group) and 9 weeks after baseline (control group).
This parental guidance consists of a weekly 4-session intervention. The aim of the sessions are to provide child support in the oncological context, mainly through communication.
Discussion:
This parental guidance would lead to improvements in knowledge, communication, parental self-efficacy and emotional regulation associated with child support.
详细描述
Introduction :
Parents raise many questions about the impact of the cancer on their children and on the communication with them about the disease. For many of them, the cancer impact their parental self-efficacy. This decrease of self-efficacy is related to difficulties to communicate openly with children and to regulate emotions in response to the feelings, reactions and questions of their children. In the same way, some parents report a lack of knowledge on how to support their children. They express doubts concerning the way they speak about cancer with their children.
Objectives of the study :
The primary objective of this study is to test the contribution and effectiveness of a psychological intervention in relation to the delivery of an informational booklet regarding participants' communication with the child in the oncology context. This intervention should increase participants' sense of communicative competence and communicationnal behaviors with children.
The secondary objectives is to evaluate the improvement of the participants' regarding the knowledge of how to support a child facing a parent's cancer, the emotional regulating capacity associated with participants' communication with the child, the evolution of the participants' concerns about the child. When the intervention is carried out in a dyad, it should also improve mutual support between participants.
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
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Significant caregiver of a child aged between 3 and 18 who's facing parental cancer
- •Participants must be of legal age
- •Participants must not have an acute psychiatric or neurological disorder
- •Participants must have sufficient command of French (speaking, writing, reading)
- •Completing a written informed consent
排除标准
- •Pre-terminal or terminal stage of cancer of the parent
- •Death of the parent
结局指标
主要结局
Change of the communicational behavior
时间窗: 8-9 weeks
Assessment through a content analysis of the responses given by the participants in the semi-directive interview. The main domains explore by the semi directive interview are: description of the communication, feelings during the communication and communicational behaviors. Comparing the responses in T1 with those in T2 will highlight the evolution of the communicational behaviors with the child.
Change of the parental self-efficacy in communication
时间窗: 8-9 weeks
Assessment through a self-reported scale created for the study and completed by the participants named "Sense of communicational competence with the child". The questionnaire is composed of 16 items. The scale represents the level of certainty regarding the proposed items. The questionnaire has a 10 points Likert scale. The scale ranges is from 0 to 10. 0 means " not at all certain " and 10 "quite certain". Change in the parental self-efficacy in communication is assessed by comparing the questionnaire completed in T1 with the one completed in T2. Parental self-efficacy is also analyzed through a content analysis of the responses given by the participants in the semi-structured interview. The presence of words such as confident, capable or opposite will provide insight into the sense of parental self-efficacy. Comparing the responses in T1 with those in T2 will highlight the change of parental self-efficacy through the increase or decrease in the occurrence of a word.
次要结局
- Evaluation of the Communicationnal difficulties with the child(8-9 weeks)
- Evaluation of the Emotional distress(8-9 weeks)
- Description of the Communicationnal difficulties with the child(8-9 weeks)
- Evaluation of the mutual support between participants(8-9 weeks)
- Evaluation of parenting concerns(8-9 weeks)
- Evaluation of the knowledges of the participant about the understanding of children in oncological context(8-9 weeks)
研究者
Aurore Liénard
Aurore Lienard, Coordinator of the Psycho-Oncology Clinic at the Bordet Institute
Université Libre de Bruxelles