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Clinical Trials/NCT03330145
NCT03330145CompletedNot Applicable

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

University Hospital, Toulouse1 site in 1 country38 target enrollmentStarted: November 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
38
Locations
1
Primary Endpoint
Inventory of Complicated Grief

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
6 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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
  • Signed consent form
  • Having lost mother or father of the child within the last 3 months

Exclusion Criteria

  • Both parents are dead
  • Medical disease
  • Ongoing legal procedure regarding the death
  • Decline to take part to the study
  • Mental retardation or schizophrenia
  • Ongoing legal procedure regarding the death

Arms & Interventions

children who lost a parent to cancer

Experimental

Children will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss

Intervention: Scales, questionnaires and inventory (Behavioral)

children who lost a parent not to cancer

Active Comparator

Children will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss

Intervention: Scales, questionnaires and inventory (Behavioral)

Outcomes

Primary Outcomes

Inventory of Complicated Grief

Time Frame: 6 months post-loss

Complicated Grief symptoms at 6 months post-loss among children aged from 6 to 17 years Measured by the Inventory of Complicated Grief

Secondary Outcomes

  • Determined if early factors could explain differences of symptoms of depression developement between the cause of death of the parent (cancer or another cause)(At 3 months post-loss)
  • Evaluation of the impact of the cause of parents death (cancer or other cause) on complicated grief symptoms development.(At 6 and 12 months post-loss)
  • Inventory of Complicated Grief for Evaluation of paths of grief symptoms developement(At 3 and 12 months post-loss)
  • Influence of grief symptoms of the parent staying in life(At 3 months and 12 months post-loss)
  • Evaluation of the impact of the cause of parents death (cancer or other cause) on post-traumatic stress developement.(At 6 and 12 months post-loss)
  • Evaluation of the impact of the cause of parents death (cancer or other cause) on depression developement.(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)(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)(At 3 months post-loss)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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