Long-term Consequences of Bereavement in Children, Adolescents and Young Adults

Bereavement Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453699
• Other study ID #: 1-2009
• Secondary ID: 7134-082009-41-3
• Status: Completed
• Phase: N/A
• First received: October 11, 2011
• Last updated: August 11, 2014
• Start date: September 2009
• Est. completion date: November 2012

Study information

• Verified date: August 2014
• Source: Danish Cancer Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1225660
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• persons born in Denmark

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bereavement

Locations

Country	Name	City	State
Denmark	Department of Psychosocial Cancer Research, Institute of Cancer Epidemiology, Danish Cancer Society	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
Danish Cancer Society	Center for Crisis Psychology, Children´s Welfare, Counselling and Research Center for Grieving Children, Teens and Young Adults, Statens Serum Institut

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization for affective disorder	Danish Psychiatric Central Register	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	No
Primary	Use of antidepressive medication	The Danish National Prescription Registry	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	No
Primary	Suicide	Danish Register of Causes of Death	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	No
Primary	Severe cardiovascular disease	The Danish National Patient Register	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	No
Primary	Education level	The Register-based System of Demographics and Social Statistics in Denmark	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	No
Primary	Employment	The Register-based System of Demographics and Social Statistics in Denmark	Employment status at age 30, death, first emigration or end of follow-up, an expected average of 8 years.	No
Primary	Quality of life	SF-36, Self-reported questionnaire	Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)	No
Primary	Complicated grief	Inventory of Complicated Grief/ Prolonged Grief Disorder (PG-13) and Centrality of Event Scale, Self-reported questionnaire	Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)	No
Primary	PTSD	Harvard Trauma Questionnaire (HTQ), Self-reported questionnaire	Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)	No
Primary	Existentiality	Posttraumatic Growth Inventory (PTGI, Self-reported questionnaire	Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)	No
Primary	Depressive symptoms	The Center for Epidemiological Studies Depression Scale (CES-C)	Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)	No
Secondary	Relationship functioning	Quality of relationship and intimacy, Self-reported questionnaire	Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)	No
Secondary	Support when losing a parent	Self-report items	Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)	No
Secondary	Lifestyle (smoking, alcohol, exercise)	Self-reported questionnaire	Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)	No
Secondary	Coping	Brief cope, Self-reported questionnaire	Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years)	No