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

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

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.

Study Overview

• Status: Completed
• Conditions: Grief
• Intervention / Treatment: Behavioral: Scales, questionnaires and inventory

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31000
    • Psychiatrie de l'enfant et de l'adolescent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: children who lost a parent to cancer; 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; Children will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss; Other Names: Inventory
ACTIVE_COMPARATOR: children who lost a parent not to cancer; 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; Children will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss; Other Names: Inventory

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Jean-Philippe RAYNAUD, MD, University Hospital, Toulouse

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2015
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): May 1, 2020

Study Registration Dates

• First Submitted: May 27, 2016
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (ACTUAL): November 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Cancer; Children; Risk Factors; Complicated Grief
• Other Study ID Numbers: RC31/15/7458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO