Assessing the Efficacy of a Psychosocial Intervention Program for Siblings of Children With Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessing the Efficacy of a Psychosocial Intervention Program for Siblings of Children With Cancer

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Control Group
* Behavioral: Experimental Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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. | Behavioral: Control Group<br>* 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. CG 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.<br>|
| Experimental: Experimental Group<br>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. | Behavioral: Experimental Group<br>* The experimental group will be detailed, session by session, in the manual written for this purpose. It addresses on topic per session (respecting each other, medical information about cancer, family relationships, sibling's fears and feelings, relationship between siblings, relationships at school, generating hope.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline depression scores at end of intervention and 3 months | Measured by Childhood Depression Inventory (CDI) [Kovacs, 1992]. ). This self-rated, 27-item scale was designed for children between the ages of 7-17. | day 1, 8 weeks later, and 3 months after day 1 | 
| Change from baseline anxiety scores at end of intervention and 3 months | Measured by State Trait Anxiety Inventory for Children (STAIC)( Spielberger, 1983). This is a 20-item self-report measure | day 1, 8 weeks later, and 3 months after day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge about cancer | Siblings Perception Questionnaire (SPQ) (Barbarin, 1995) is a 17-item questionnaire specifically designed for siblings of children with cancer | day 1, 8 weeks later, and 3 months after day 1 | 
| quality of life | Pediatric Quality of Life Inventory (PedsQL 4.0 Varni, 1999) is a 23-item, standardized generic measure of health related QOL. The PedsQL, self-report and parent proxy, is composed of four subscales: Physical, Social, Emotional and School Functioning and a Total score. | day 1, 8 weeks later, and 3 months after day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric cancer, psychosocial, siblings