Clinical trial NCT03330145: Complicated Grief Among Children After a Death From Cancer or Another Cause: A Longitudinal and Prospective Study (CAPS)
Official title: Risk Factors for Complicated Grief After a Death From Cancer or an Other Cause: A Longitudinal and Prospective Study Among Children and Their Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grief
Keywords: Complicated Grief
Risk Factors
Cancer
Children
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inventory of Complicated Grief
timeFrame: 6 months post-loss
Secondary outcomes:
measure: Inventory of Complicated Grief for Evaluation of paths of grief symptoms developement
timeFrame: At 3 and 12 months post-loss
measure: Influence of grief symptoms of the parent staying in life
timeFrame: At 3 months and 12 months post-loss
measure: Evaluation of the impact of the cause of parents death (cancer or other cause) on complicated grief symptoms development.
timeFrame: At 6 and 12 months post-loss
measure: Evaluation of the impact of the cause of parents death (cancer or other cause) on post-traumatic stress developement.
timeFrame: At 6 and 12 months post-loss
measure: Evaluation of the impact of the cause of parents death (cancer or other cause) on depression developement.
timeFrame: At 6 and 12 months post-loss
measure: Determined if early factors could explain differences of symptoms of complicated grief between the cause of death of the parent (cancer or another cause)
timeFrame: At 3 months post-loss
measure: 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)
timeFrame: At 3 months post-loss
measure: Determined if early factors could explain differences of symptoms of depression developement between the cause of death of the parent (cancer or another cause)
timeFrame: At 3 months post-loss
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Psychiatrie de l'enfant et de l'adolescent
Study officials:
affiliation: University Hospital, Toulouse
name: Jean-Philippe RAYNAUD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Revet A, Suc A, Auriol F, Djelantik AAAMJ, Raynaud JP, Bui E. Peritraumatic distress predicts prolonged grief disorder symptom severity after the death of a parent in children and adolescents. Eur J Psychotraumatol. 2021 Jun 28;12(1):1936916. doi: 10.1080/20008198.2021.1936916. eCollection 2021.