Assessing the Efficacy of a Psychosocial Intervention Program for Siblings of Children With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 4
- 主要终点
- Change from baseline depression scores at end of intervention and 3 months
研究概览
简要总结
The psychosocial effects of childhood cancer and its demanding medical treatment can affect not only the ill child but the whole family, particularly siblings who are often overlooked given the terrible circumstances these families face. Current evidence suggests that negative long-term psychosocial effects of childhood cancer may be more severe in siblings than in the child with cancer. Addressing these effects on siblings may benefit the child with cancer and the entire family. Thus, early psychosocial preventive interventions are needed to foster psychosocial adjustment in siblings and promote better quality of life for the entire family. The immediate objective of this study is to address siblings' psychological distress by assessing feasibility and efficacy of a manualized group intervention for siblings of children with cancer (Siblings Coping Together, SibCT). A longer term objective is that the evidence-based intervention could then be exported to other centres across Canada and internationally. Additionally, the study results will identify biomedical, personal, familial and social determinants of intervention outcomes that can guide clinical effort for those at greatest risk. Finally, the overall aim of the project is to reduce psychological distress and improve quality of life for siblings and families impacted by a cancer diagnosis and its demanding treatment.
详细描述
Siblings of children with cancer can endure great psychological distress as a result of their brother's or sister's diagnosis and treatment. Understandably, when a child has cancer, their parents' attention is focused mainly on that child and therefore the siblings' needs may not be fully addressed. Thus, siblings often develop feelings of anger, abandonment, jealousy, and fear, which may lead to an increased risk for academic difficulties, symptoms of depression and anxiety and post traumatic stress disorder, although the results are not consistent across studies. Of most concern is that psychological problems may persist through adulthood, as suggested by a recent study in which alcoholism was more prevalent among siblings of children with cancer when compared to peers and cancer survivors. Therefore, it is imperative to develop evidence based psychological intervention programs to prevent these detrimental psychological effects in siblings of children with cancer. This project aims to address siblings' psychological distress by assessing the efficacy of a manualized group intervention for siblings of children with cancer (SibCT) across three Canadian sites (SickKids, Alberta Children's Hospital, BC Women and Children's Hospital) using a randomized control trial (RCT) experimental design. A manualized intervention is considered the gold standard for psychological intervention as it ensures replicability of the study and intervention fidelity. The primary aim is to demonstrate that survivors in the SibCT group (EG) demonstrate decreased symptoms of depression and anxiety improve their overall quality of life compared to an attention control group (CG). A secondary aim is to show that compared to CG, EG will show improvements in secondary measures of quality of life as well as knowledge about cancer. We will also explore other factors such as disease and treatment variables, social contextual variables, individual (sibling) variables and family variables. Randomized Control Trial design with repeated measures will be used. Siblings of children on active cancer treatment and at least 3 months from diagnosis to reduce parental burden; between 8-16 years of age will be included in the study. Siblings will be randomized to either the EG or CG. Approximately 184 siblings will be recruited across the three pediatric centres. After baseline assessment, both groups will have 8 two-hour weekly group sessions consisting of arts and crafts and games, and two post-intervention assessments; at the end of session 8 and three months later. In the EG the critical ingredient has education and social and therapeutic problem solving components based on the manual. Examples of weekly session topics include: age-appropriate medical information about cancer; siblings' fears and feelings; relationships at school, etc. The CG will not have any education or therapeutic-based components. Rigorous testing of the efficacy of an intervention program is a critical step for developing evidence-based treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Siblings of children on active cancer treatment at one or the three sites; at least three months from diagnosis to reduce parental burden
- •Siblings and one caregiver are fluent in English, ensuring full participation
- •Siblings are age 8-16 years
排除标准
- •Siblings who are diagnosed with a developmental or psychiatric disorder which will prevent full group participation
- •Are receiving active psychological treatment at the time of recruitment
- •Has a brother/sister who is receiving palliative care, and is not expected to live longer than 6 months or who had died.
研究组 & 干预措施
Control Group
Behavioural: Participants in this arm will experience an 8-week manualized intervention program with activities and games. Sessions will NOT be designed around a specific theme related to childhood cancer and sibling relationships. Activities and games will NOT have a specific focus. Sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site.
干预措施: Control Group (Behavioral)
Experimental Group
Behavioural: Participants in this arm will experience an 8-week manualized intervention program which focuses on education, therapeutic problem solving, and social support. Each intervention session is structured by theme relevant to the cancer experience and themes are addressed through fun activities, games, arts, and crafts.To maximize the therapeutic effect of the intervention fun work (homework) will be assigned after each session. Training for the EG facilitators requires reading and studying the manual to become fully familiarized with the intervention approaches, observing group sessions through a one-way mirror prior to participation as a group facilitator, and participating as a group facilitator assistant for the intervention program.
干预措施: Experimental Group (Behavioral)
结局指标
主要结局
Change from baseline depression scores at end of intervention and 3 months
时间窗: day 1, 8 weeks later, and 3 months after day 1
Measured by Childhood Depression Inventory (CDI) \[Kovacs, 1992\]. ). This self-rated, 27-item scale was designed for children between the ages of 7-17.
Change from baseline anxiety scores at end of intervention and 3 months
时间窗: day 1, 8 weeks later, and 3 months after day 1
Measured by State Trait Anxiety Inventory for Children (STAIC)( Spielberger, 1983). This is a 20-item self-report measure
次要结局
- quality of life(day 1, 8 weeks later, and 3 months after day 1)
- knowledge about cancer(day 1, 8 weeks later, and 3 months after day 1)
研究者
Maru Barrera
Psychologist
The Hospital for Sick Children