GriefCAPSNCT03330145
Complicated Grief Among Children After a Death From Cancer or Another Cause: A Longitudinal and Prospective Study (CAPS)
A study testing Scales, questionnaires and inventory in people with Grief, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Grief
- What is being tested?
- Scales, questionnaires and inventory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Grief
- Being tested
- Scales, questionnaires and inventory
- Keywords
- Complicated Grief, Risk Factors, Cancer, Children
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scales, questionnaires and inventoryBehavioural
Also called Inventory
Children will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss
| Study group | Role | What they receive |
|---|---|---|
| children who lost a parent to cancer | Experimental | Children will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss Receives: Behavioral: Scales, questionnaires and inventory |
| children who lost a parent not to cancer | Active comparator | Children will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss Receives: Behavioral: Scales, questionnaires and inventory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months post-loss
Secondary outcomes (8)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 3 months post-loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study startNov 2015
- Primary completionApr 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GriefStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe RAYNAUD, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330145
- Sponsor's protocol ID
- RC31/15/7458
- Acronym
- CAPS
- Status last verified
- Jul 2021
- First submitted
- 27 May 2016
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 34249245
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03330145
- Acronym / sponsor ID
- CAPS / RC31/15/7458
- Conditions
- Grief
- Keywords
- Complicated Grief, Risk Factors, Cancer, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children who lost a parent to cancer | Experimental | Behavioral: Scales, questionnaires and inventoryChildren will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss |
| children who lost a parent not to cancer | Active comparator | Behavioral: Scales, questionnaires and inventoryChildren will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
- Signed consent form
- Having lost mother or father of the child within the last 3 months
Key exclusion criteria (8 listed)
- Both parents are dead
- Medical disease
- Ongoing legal procedure regarding the death
- Decline to take part to the study
- Mental retardation or schizophrenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scales, questionnaires and inventoryAlso: InventoryChildren will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss | Behavioural | children who lost a parent not to cancer, children who lost a parent to cancer |
Primary outcome
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
8 secondary outcomes
Inventory of Complicated Grief for Evaluation of paths of grief symptoms developement
Time frame: At 3 and 12 months post-loss
Influence of grief symptoms of the parent staying in life
Time frame: 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.
Time frame: 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.
Time frame: At 6 and 12 months post-loss
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Results publication: PubMed 34249245Revet 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe RAYNAUD, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scales, questionnaires and inventory in people with Grief, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inventory of Complicated Grief (time frame: 6 months post-loss). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03330145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.