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

Grief Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330145
• Other study ID #: RC31/15/7458
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: May 2020

Study information

• Verified date: July 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Grief

Intervention

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

Locations

Country	Name	City	State
France	Psychiatrie de l'enfant et de l'adolescent	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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