Complicated Grief Among Children After a Death From Cancer or Another Cause: A Longitudinal and Prospective Study (CAPS)

Study Overview
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Brief Summary
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The purpose of this study is to identify risk factors of Complicated Grief (CG) among children and adolescents who lost a parent to cancer or from an other cause.

Detailed Description
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Although the intensity of the grief and life disruption usually subsides in the months following the loss of a loved one, approximately 7% of bereaved individuals will continue to experience persistent and intense grief-related symptoms associated with marked distress and functional impairment years after the death. While several studies aimed to evaluate risk factors of CG among adults, little is known regarding CG among children and adolescents. Therefore, prospective research directly examining the impact of bereavement on post-loss psychiatric symptoms, including CG, post-traumatic-stress disorder (PTSD), depression, attentional and behavioral avoidance among children are needed. Improving our understanding of CG risk factors among children will help direct healthcare professionals' clinical attention toward screening and care of this underserved population. Furthermore, identifying mechanisms explaining why cancer bereaved children may be at greater risk for persistent psychological distress and CG will inform the development of preventive, early intervention and treatment strategies. Participants will be recruited to the Child and Adolescent grief counseling of the College Hospital of Toulouse as well as with the Team Regional Resource Pediatric Palliative Care Enfant-Do. At 3, 6 and 12 months post-loss, children and their parent will be invited to complete questionnaires assessing peritraumatic dissociative experiences, peritraumatic distress, security attachment, symptoms of CG, symptoms of PTSD and attentional avoidance.

Official Title
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Risk Factors for Complicated Grief After a Death From Cancer or an Other Cause: A Longitudinal and Prospective Study Among Children and Their Parents

Conditions
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Grief

Intervention / Treatment
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* Behavioral: Scales, questionnaires and inventory


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children : Having lost a parent within the last 3 months Signed consent form from the parent To have health care coverage by the French social security Parents : Signed consent form Having lost mother or father of the child within the last 3 months Exclusion Criteria: Children: Both parents are dead Medical disease Ongoing legal procedure regarding the death Parents : Decline to take part to the study Mental retardation or schizophrenia Ongoing legal procedure regarding the death

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: children who lost a parent to cancer<br>Children will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss | Behavioral: Scales, questionnaires and inventory<br>* Children will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss<br>* Other names: Inventory;|
| Active Comparator: children who lost a parent not to cancer<br>Children will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss | Behavioral: Scales, questionnaires and inventory<br>* Children will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss<br>* Other names: Inventory;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inventory of Complicated Grief | Complicated Grief symptoms at 6 months post-loss among children aged from 6 to 17 years Measured by the Inventory of Complicated Grief | 6 months post-loss | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inventory of Complicated Grief for Evaluation of paths of grief symptoms developement | Analysed symptoms and divided subject between 4 groups according to their symptoms. Group 1 : High levels of grief symptoms at 3 months wich will decrease at 12 months Group 2 : Low levels of grief symptoms at 3 months wich will stay low at 12 months Group 3 : High levels of grief symptoms at 3 months wich will stay high at 12 months Group 4 : Low levels of grief symptoms at 3 months wich will increase at 12 months | At 3 and 12 months post-loss | 
| Influence of grief symptoms of the parent staying in life | Evaluation of the influence of grief symptoms of the parent staying in life on the level of complicated grief symptoms development (i) One group of children will have high levels of grief symptoms at T0 which will decrease over the time. (ii) One group will have low levels of grief symptoms at T0 which will remain low over the time. (iii) One group will have high levels of grief symptoms at T0 which will remain high over the time. (iiii) One group will have low levels of grief symptoms at T0 which will increase over the time. | At 3 months and 12 months post-loss | 
| Evaluation of the impact of the cause of parents death (cancer or other cause) on complicated grief symptoms development. | Questionnaire will be used to measure these symptoms : Inventory of Complicated Grief | At 6 and 12 months post-loss | 
| Evaluation of the impact of the cause of parents death (cancer or other cause) on post-traumatic stress developement. | Questionnaires will be used to measure these symptoms : Peritraumatic Dissociative Experiences Questionnaire and Peritraumatic Distress Inventory | At 6 and 12 months post-loss | 
| Evaluation of the impact of the cause of parents death (cancer or other cause) on depression developement. | Questionnaire will be used to measure these symptoms : Children Depression Inventory | At 6 and 12 months post-loss | 
| Determined if early factors could explain differences of symptoms of complicated grief between the cause of death of the parent (cancer or another cause) | Questionnaire will be used to measure these symptoms : Inventory of Complicated Grief | At 3 months post-loss | 
| Determined if early factors could explain differences of symptoms of post-traumatic stress developement between the cause of death of the parent (cancer or another cause) | Questionnaire will be used to measure these symptoms : Peritraumatic Dissociative Experiences Questionnaire and Peritraumatic Distress Inventory | At 3 months post-loss | 
| Determined if early factors could explain differences of symptoms of depression developement between the cause of death of the parent (cancer or another cause) | Questionnaire will be used to measure these symptoms : Children Depression Inventory | At 3 months post-loss | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complicated Grief, Risk Factors, Cancer, Children