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Completed

NCT Number: NCT03330145

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

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.

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Key information

Conditions

Grief Neoplasms

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatrie de l'enfant et de l'adolescent

Toulouse, 31000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scales, questionnaires and inventory

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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

Acronym: CAPS

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2017
Registry last updated
Jul 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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