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Trial record 3 of 21 for:    Recruiting, Not yet recruiting, Available Studies | "Bereavement"

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

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ClinicalTrials.gov Identifier: NCT03330145
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Grief Behavioral: Scales, questionnaires and inventory Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 119 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : November 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bereavement

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 Name: 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 Name: Inventory




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Inventory of Complicated Grief for Evaluation of paths of grief symptoms developement [ Time Frame: At 3 and 12 months post-loss ]

    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


  2. Influence of grief symptoms of the parent staying in life [ Time Frame: At 3 months and 12 months post-loss ]

    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.


  3. Evaluation of the impact of the cause of parents death (cancer or other cause) on complicated grief symptoms development. [ Time Frame: At 6 and 12 months post-loss ]
    Questionnaire will be used to measure these symptoms : Inventory of Complicated Grief

  4. Evaluation of the impact of the cause of parents death (cancer or other cause) on post-traumatic stress developement. [ Time Frame: At 6 and 12 months post-loss ]
    Questionnaires will be used to measure these symptoms : Peritraumatic Dissociative Experiences Questionnaire and Peritraumatic Distress Inventory

  5. Evaluation of the impact of the cause of parents death (cancer or other cause) on depression developement. [ Time Frame: At 6 and 12 months post-loss ]
    Questionnaire will be used to measure these symptoms : Children Depression Inventory

  6. Determined if early factors could explain differences of symptoms of complicated grief between the cause of death of the parent (cancer or another cause) [ Time Frame: At 3 months post-loss ]
    Questionnaire will be used to measure these symptoms : Inventory of Complicated Grief

  7. 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) [ Time Frame: At 3 months post-loss ]
    Questionnaire will be used to measure these symptoms : Peritraumatic Dissociative Experiences Questionnaire and Peritraumatic Distress Inventory

  8. Determined if early factors could explain differences of symptoms of depression developement between the cause of death of the parent (cancer or another cause) [ Time Frame: At 3 months post-loss ]
    Questionnaire will be used to measure these symptoms : Children Depression Inventory



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330145


Contacts
Contact: Jean-Philippe RAYNAUD, Pr 05-61-77-78-74 raynaud.jp@chu-toulouse.fr

Locations
France
Psychiatrie de l'enfant et de l'adolescent Recruiting
Toulouse, France, 31000
Contact: Jean-Pierre RAYNAUD, MD PhD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Jean-Philippe RAYNAUD, Pr University Hospital, Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03330145     History of Changes
Other Study ID Numbers: RC31/15/7458
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Toulouse:
Complicated Grief
Risk Factors
Cancer
Children