Trial record 2 of 9 for:    Open Studies | "Bereavement"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Danish Cancer Society.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Statens Serum Institut
Center for Crisis Psychology, Norway
Danish Counselling and Research Center for Grieving Children, Teens and Young Ad
Children's Welfare
Information provided by (Responsible Party):
Christoffer Johansen, Danish Cancer Society
ClinicalTrials.gov Identifier:
NCT01453699
First received: October 11, 2011
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

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.


Condition
Bereavement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Danish Cancer Society:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    The Center for Epidemiological Studies Depression Scale (CES-C)


Secondary Outcome Measures:
  • Relationship functioning [ Time Frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years) ] [ Designated as safety issue: No ]
    Quality of relationship and intimacy, Self-reported questionnaire

  • Support when losing a parent [ Time Frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years) ] [ Designated as safety issue: No ]
    Self-report items

  • Lifestyle (smoking, alcohol, exercise) [ Time Frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years) ] [ Designated as safety issue: No ]
    Self-reported questionnaire

  • Coping [ Time Frame: Participants will be answering the questionnaire once (not at a specifik age but between 18-40 years) ] [ Designated as safety issue: No ]
    Brief cope, Self-reported questionnaire


Estimated Enrollment: 1225660
Study Start Date: September 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Nationwide population-based cohort (Denmark)

Criteria

Inclusion Criteria:

  • persons born in Denmark

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453699

Contacts
Contact: Christoffer Johansen, MD, PhD, DSc 45 35257627 christof@cancer.dk
Contact: Charlotte W Appel, MSc 45 35257638 appel@cancer.dk

Locations
Denmark
Department of Psychosocial Cancer Research, Institute of Cancer Epidemiology, Danish Cancer Society Recruiting
Copenhagen, Denmark, 2100
Contact: Christoffer Johansen, MD, PhD, DSc    45 35257627    christof@cancer.dk   
Contact: Charlotte W Appel, MSc    45 35257638    appel@cancer.dk   
Sponsors and Collaborators
Danish Cancer Society
Statens Serum Institut
Center for Crisis Psychology, Norway
Danish Counselling and Research Center for Grieving Children, Teens and Young Ad
Children's Welfare
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
  More Information

No publications provided

Responsible Party: Christoffer Johansen, Head of Department of Psychosocial Cancer Research, Danish Cancer Society
ClinicalTrials.gov Identifier: NCT01453699     History of Changes
Other Study ID Numbers: 1-2009, 7134-08, 2009-41-3506
Study First Received: October 11, 2011
Last Updated: October 24, 2011
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Danish Cancer Society:
Bereavement
grief
early parental death
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

Additional relevant MeSH terms:
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014