- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01453699
Long-term Consequences of Bereavement in Children, Adolescents and Young Adults
Bereavement in Children, Adolescents and Young Adults. - A Study of Health and Psychosocial Well-being in Adults Who Have Experienced Early Parental Death
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2100
- Department of Psychosocial Cancer Research, Institute of Cancer Epidemiology, Danish Cancer Society
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- persons born in Denmark
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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Danish Psychiatric Central Register
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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
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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
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The Danish National Prescription Registry
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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
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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
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Danish Register of Causes of Death
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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
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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
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The Danish National Patient Register
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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
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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
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The Register-based System of Demographics and Social Statistics in Denmark
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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
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Employment
Time Frame: Employment status at age 30, death, first emigration or end of follow-up, an expected average of 8 years.
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The Register-based System of Demographics and Social Statistics in Denmark
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Employment status at age 30, death, first emigration or end of follow-up, an expected average of 8 years.
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Quality of life
Time Frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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SF-36, Self-reported questionnaire
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Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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Complicated grief
Time Frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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Inventory of Complicated Grief/ Prolonged Grief Disorder (PG-13) and Centrality of Event Scale, Self-reported questionnaire
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Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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PTSD
Time Frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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Harvard Trauma Questionnaire (HTQ), Self-reported questionnaire
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Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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Existentiality
Time Frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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Posttraumatic Growth Inventory (PTGI, Self-reported questionnaire
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Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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Depressive symptoms
Time Frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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The Center for Epidemiological Studies Depression Scale (CES-C)
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Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Relationship functioning
Time Frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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Quality of relationship and intimacy, Self-reported questionnaire
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Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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Support when losing a parent
Time Frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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Self-report items
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Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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Lifestyle (smoking, alcohol, exercise)
Time Frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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Self-reported questionnaire
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Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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Coping
Time Frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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Brief cope, Self-reported questionnaire
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Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christoffer Johansen, MD, PhD, DSc, Institute of Cancer Epidemiology, Danish Cancer Society
- Study Chair: Charlotte W Appel, MSc, Institute of Cancer Epidemiology, Danish Cancer Society
- Study Chair: Pernille E Bidstrup, PhD, Institute of Cancer Epidemiology, Danish Cancer Society
- Study Chair: Henrik Hjalgrim, PhD, Statens Serum Institut
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-2009
- 7134-08 (Other Grant/Funding Number: TrygFonden)
- 2009-41-3506 (Other Identifier: Danish Data Protection Agency)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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