Clinical trial NCT01453699: Long-term Consequences of Bereavement in Children, Adolescents and Young Adults
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Danish Cancer Society
Sponsor class: OTHER
Collaborators: name: Statens Serum Institut
name: Center for Crisis Psychology
name: Counselling and Research Center for Grieving Children, Teens and Young Adults
name: Children´s Welfare
First posted: 2011-10-18
Enrollment: 1225660
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Nationwide population-based cohort (Denmark)

Brief 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.

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:

1. 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.
2. 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.
3. 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:

1. Persons who have lost a parent and participated in intervention programmes (identified through counseling centers),
2. Persons who have lost a parent, and not participated in intervention programmes (randomly selected matched on age and gender) and
3. 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.

Eligibility criteria: Inclusion Criteria:

* persons born in Denmark

Exclusion Criteria:

-

Primary outcomes:
measure: Hospitalization for affective disorder
timeFrame: 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
measure: Use of antidepressive medication
timeFrame: 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
measure: Suicide
timeFrame: 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
measure: Severe cardiovascular disease
timeFrame: 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
measure: Education level
timeFrame: 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
measure: Employment
timeFrame: Employment status at age 30, death, first emigration or end of follow-up, an expected average of 8 years.
measure: Quality of life
timeFrame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
measure: Complicated grief
timeFrame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
measure: PTSD
timeFrame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
measure: Existentiality
timeFrame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
measure: Depressive symptoms
timeFrame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
Secondary outcomes:
measure: Relationship functioning
timeFrame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
measure: Support when losing a parent
timeFrame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
measure: Lifestyle (smoking, alcohol, exercise)
timeFrame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
measure: Coping
timeFrame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Psychosocial Cancer Research, Institute of Cancer Epidemiology, Danish Cancer Society
Study officials:
affiliation: Institute of Cancer Epidemiology, Danish Cancer Society
name: Christoffer Johansen, MD, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Cancer Epidemiology, Danish Cancer Society
name: Charlotte W Appel, MSc
role: STUDY_CHAIR
affiliation: Institute of Cancer Epidemiology, Danish Cancer Society
name: Pernille E Bidstrup, PhD
role: STUDY_CHAIR
affiliation: Statens Serum Institut
name: Henrik Hjalgrim, PhD
role: STUDY_CHAIR
References: