BereavementNCT01453699
Long-term Consequences of Bereavement in Children, Adolescents and Young Adults
An observational study of Bereavement, run by Danish Cancer Society at 1 site in Denmark.
Trial summary
The purpose of this study is to examine how the death of a parent as a child, adolescent or young adult affects health and psychosocial wellbeing in adult life and to evaluate the impact in adult life of counseling to children, adolescents and young adults who lost a parent. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bereavement
- How many people
- 1,225,660 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to Nov 2012
- Phase
- Observational
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Nationwide population-based cohort (Denmark)
Who may be able to join
- persons born in Denmark
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Psychosocial Cancer Research, Institute of Cancer Epidemiology, Danish Cancer Society
Copenhagen, 2100
About this study
Official title: Bereavement in Children, Adolescents and Young Adults. - A Study of Health and Psychosocial Well-being in Adults Who Have Experienced Early Parental Death
The purpose of this study is to examine how the death of a parent as a child, adolescent or young adult affects health and psychosocial wellbeing in adult life and to evaluate the impact in adult life of counseling to children, adolescents and young adults who lost a parent.
Read the detailed description
Early parental death experienced by 4% of the children in Western countries, is considered to be the most stressful and potentially harmful childhood life event and the health consequences may depend on the nature of the bereavement (e.g. relationship with bereaved), as well as by interpersonal (e.g. social support), intrapersonal (e.g. age and genetics), appraisal and coping factors. Studies have shown that children and adolescents have a greater risk of getting a psychiatric diagnose as well as psychological and social problems. Despite of the obvious consequences of losing a parent, there is a lack of systematic studies on the consequences later in life as well as studies that evaluate the counseling possibilities the children and adolescents are offered.
The study will investigate:
- Long-term health effects of experiencing parental death as a child adolescent or young adult. Focus will be on psychiatric outcomes including depression, severe cardiovascular disease, suicide, suicide attempts, psychological well-being and health related behavior.
- Long term effects of experiencing parental death as a child, adolescent or young adult on socioeconomic outcomes as education, employment, marital status/ cohabitation status and number of children/age when having children.
- The long-term psychosocial and behavioral impact of psychological intervention programmes to children, adolescents and young adults who have experienced the death of a parent. Focus will be on: Depressive symptoms, quality of life, posttraumatic stress disorder, life style, relationship functioning, grief and spirituality.
A nationwide register based cohort of people born in Denmark will be established. Long-term health effects and socioeconomic outcomes of experiencing parental death will be based on nationwide clinical and administrative registries. Exposure is defined as experiencing the death of a parent before age 30. The long-term psychosocial and behavioral impact of psychological intervention programmes will be based on a combination of questionnaire data and data from registries.
The part of the study using data from registries will be based on the nationwide cohort. The questionnaire based part of the study will include 3 groups selected from the nationwide cohort:
- Persons who have lost a parent and participated in intervention programmes (identified through counseling centers),
- Persons who have lost a parent, and not participated in intervention programmes (randomly selected matched on age and gender) and
- Persons who have not lost a parent (randomly selected matched on age and gender).
An invitation letter will be send to the 3 groups (5500 persons) by mail, and they will be asked to complete one questionnaire online.
- Conditions
- Bereavement
- Keywords
- Bereavement, early parental death, grief, affective disorders, depression, depressive symptoms, socioeconomic factors, suicide, attempted suicide, antidepressive agents, cardiovascular diseases, quality of life, Long-term health effects, Socioeconomic outcomes, Psychosocial well-being
- Medical subject headings
- Parental Death, Mood Disorders, Depression, Suicide, Suicide, Attempted, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization for affective disorder
Danish Psychiatric Central Register
Measured: Paticipants will be followed from age 15 until date of first hospitalization for an affective disorder, death, first emigration or end of follow up, an expected average of 12 years
Use of antidepressive medication
The Danish National Prescription Registry
Measured: Paticipants will be followed from age 20 until date of second independantly prescription of antidepressive medication, death, first emigration or end of follow up, an expected average of 9 years
Suicide
Danish Register of Causes of Death
Measured: Paticipants will be followed from age 18 until date of suicide, other causes of death, first emigration or end of follow up, an expected average of 15 years
Severe cardiovascular disease
The Danish National Patient Register
Measured: Paticipants will be followed from age 18 until date of first hospitalization for severe cardiovascular disease, death, first emigration or end of follow up, an expected average of 15 years
Education level
The Register-based System of Demographics and Social Statistics in Denmark
Measured: Participants will be followed from age 18 until highest attained educational level, death, first emigration or end of follow up, an average of 20 years
Employment
The Register-based System of Demographics and Social Statistics in Denmark
Measured: Employment status at age 30, death, first emigration or end of follow-up, an expected average of 8 years.
Quality of life
SF-36, Self-reported questionnaire
Measured: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
Complicated grief
Inventory of Complicated Grief/ Prolonged Grief Disorder (PG-13) and Centrality of Event Scale, Self-reported questionnaire
Measured: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
PTSD
Harvard Trauma Questionnaire (HTQ), Self-reported questionnaire
Measured: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
Existentiality
Posttraumatic Growth Inventory (PTGI, Self-reported questionnaire
Measured: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
Depressive symptoms
The Center for Epidemiological Studies Depression Scale (CES-C)
Measured: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
Secondary outcomes (4)
Relationship functioning
Quality of relationship and intimacy, Self-reported questionnaire
Measured: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
Support when losing a parent
Self-report items
Measured: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
Lifestyle (smoking, alcohol, exercise)
Self-reported questionnaire
Measured: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
Coping
Brief cope, Self-reported questionnaire
Measured: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startSep 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BereavementStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,225,660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Cancer Society
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut, Center for Crisis Psychology, Counselling and Research Center for Grieving Children, Teens and Young Adults, Children´s Welfare
- Responsible party
- Principal investigator, Christoffer Johansen, Danish Cancer Society
- Investigators
- Christoffer Johansen, MD, PhD, DSc, Principal investigator, Institute of Cancer Epidemiology, Danish Cancer SocietyCharlotte W Appel, MSc, Study chair, Institute of Cancer Epidemiology, Danish Cancer SocietyPernille E Bidstrup, PhD, Study chair, Institute of Cancer Epidemiology, Danish Cancer SocietyHenrik Hjalgrim, PhD, Study chair, Statens Serum Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453699
- Sponsor's protocol ID
- 1-2009
- Other IDs
- 7134-08, 2009-41-3506
- Status last verified
- Aug 2014
- First submitted
- 11 Oct 2011
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bereavement in Children, Adolescents and Young Adults. - A Study of Health and Psychosocial Well-being in Adults Who Have Experienced Early Parental Death
- ClinicalTrials.gov ID
- NCT01453699
- Acronym / sponsor ID
- 1-2009
- Conditions
- Bereavement
- Keywords
- Bereavement, early parental death, grief, affective disorders, depression, depressive symptoms, socioeconomic factors, suicide, attempted suicide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,225,660 participants (actual)
- Lead sponsor
- Danish Cancer SocietyUniversity, hospital or other
- Collaborators
- Statens Serum Institut, Center for Crisis Psychology, Counselling and Research Center for Grieving Children, Teens and Young Adults, Children´s Welfare
- Study start
- Sep 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 18 Oct 2011 (estimated)
- 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 examine how the death of a parent as a child, adolescent or young adult affects health and psychosocial wellbeing in adult life and to evaluate the impact in adult life of counseling to children, adolescents and young adults who lost a parent.
Detailed description
Early parental death experienced by 4% of the children in Western countries, is considered to be the most stressful and potentially harmful childhood life event and the health consequences may depend on the nature of the bereavement (e.g. relationship with bereaved), as well as by interpersonal (e.g. social support), intrapersonal (e.g. age and genetics), appraisal and coping factors. Studies have shown that children and adolescents have a greater risk of getting a psychiatric diagnose as well as psychological and social problems. Despite of the obvious consequences of losing a parent, there is a lack of systematic studies on the consequences later in life as well as studies that evaluate the counseling possibilities the children and adolescents are offered.
The study will investigate:
- Long-term health effects of experiencing parental death as a child adolescent or young adult. Focus will be on psychiatric outcomes including depression, severe cardiovascular disease, suicide, suicide attempts, psychological well-being and health related behavior.
- Long term effects of experiencing parental death as a child, adolescent or young adult on socioeconomic outcomes as education, employment, marital status/ cohabitation status and number of children/age when having children.
- The long-term psychosocial and behavioral impact of psychological intervention programmes to children, adolescents and young adults who have experienced the death of a parent. Focus will be on: Depressive symptoms, quality of life, posttraumatic stress disorder, life style, relationship functioning, grief and spirituality.
A nationwide register based cohort of people born in Denmark will be established. Long-term health effects and socioeconomic outcomes of experiencing parental death will be based on nationwide clinical and administrative registries. Exposure is defined as experiencing the death of a parent before age 30. The long-term psychosocial and behavioral impact of psychological intervention programmes will be based on a combination of questionnaire data and data from registries.
The part of the study using data from registries will be based on the nationwide cohort. The questionnaire based part of the study will include 3 groups selected from the nationwide cohort:
- Persons who have lost a parent and participated in intervention programmes (identified through counseling centers),
- Persons who have lost a parent, and not participated in intervention programmes (randomly selected matched on age and gender) and
- Persons who have not lost a parent (randomly selected matched on age and gender).
An invitation letter will be send to the 3 groups (5500 persons) by mail, and they will be asked to complete one questionnaire online.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nationwide population-based cohort (Denmark)
Key inclusion criteria (1 listed)
- persons born in Denmark
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospitalization for affective disorder
Time frame: Paticipants will be followed from age 15 until date of first hospitalization for an affective disorder, death, first emigration or end of follow up, an expected average of 12 years
Danish Psychiatric Central Register
Use of antidepressive medication
Time frame: Paticipants will be followed from age 20 until date of second independantly prescription of antidepressive medication, death, first emigration or end of follow up, an expected average of 9 years
The Danish National Prescription Registry
Suicide
Time frame: Paticipants will be followed from age 18 until date of suicide, other causes of death, first emigration or end of follow up, an expected average of 15 years
Danish Register of Causes of Death
Severe cardiovascular disease
Time frame: Paticipants will be followed from age 18 until date of first hospitalization for severe cardiovascular disease, death, first emigration or end of follow up, an expected average of 15 years
The Danish National Patient Register
Education level
Time frame: Participants will be followed from age 18 until highest attained educational level, death, first emigration or end of follow up, an average of 20 years
The Register-based System of Demographics and Social Statistics in Denmark
Employment
Time frame: Employment status at age 30, death, first emigration or end of follow-up, an expected average of 8 years.
The Register-based System of Demographics and Social Statistics in Denmark
Quality of life
Time frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
SF-36, Self-reported questionnaire
Complicated grief
Time frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
Inventory of Complicated Grief/ Prolonged Grief Disorder (PG-13) and Centrality of Event Scale, Self-reported questionnaire
PTSD
Time frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
Harvard Trauma Questionnaire (HTQ), Self-reported questionnaire
Existentiality
Time frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
Posttraumatic Growth Inventory (PTGI, Self-reported questionnaire
Depressive symptoms
Time frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
The Center for Epidemiological Studies Depression Scale (CES-C)
4 secondary outcomes
Relationship functioning
Time frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
Support when losing a parent
Time frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
Lifestyle (smoking, alcohol, exercise)
Time frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
Coping
Time frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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 12 Aug 2014.
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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.
Christoffer Johansen, MD, PhD, DSc principal investigator
Institute of Cancer Epidemiology, Danish Cancer Society
Charlotte W Appel, MSc study chair
Institute of Cancer Epidemiology, Danish Cancer Society
Pernille E Bidstrup, PhD study chair
Institute of Cancer Epidemiology, Danish Cancer Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bereavement, run by Danish Cancer Society at 1 site in Denmark.
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 1 inclusion and 1 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 12 Aug 2014. 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 Denmark. 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?
Hospitalization for affective disorder (time frame: Paticipants will be followed from age 15 until date of first hospitalization for an affective disorder, death, first emigration or end of follow up, an expected average of 12 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2014.