NCT06441461

Brief Summary

Mental health problems are rising among children and adolescents. This may not only impact the child's level of daily functioning but also close family members. Informal caregiving is defined as unpaid care for a sick, disabled, or other closely related person. Providing long-term informal care has been associated with detrimental stress-related outcomes, and being simultaneously active in the labor market has been highlighted as an increased burden for the caregiver. Workplaces are poorly suited for dealing with private stressors despite their potential negative consequences for the caregiver's job status and health. There is a need for improving understanding of how long-term informal caregiving impacts job and health outcomes, as well as for measures minimizing potential negative consequences among at-risk occupational groups.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,386,647

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

May 21, 2024

Last Update Submit

May 28, 2024

Conditions

Keywords

Mental health issueWork-related illnessLoss of career progression

Outcome Measures

Primary Outcomes (4)

  • Personal gross income (Level of analysis: primary informal caregiver)

    Personal gross income is analyzed as series of annual statuses.

    Up to 10 years of follow-up.

  • Employment (Level of analysis: primary informal caregiver).

    Employment is analyzed as series of annual statuses (i.e., number of weeks employed within each year during follow-up).

    Up to 10 years of follow-up.

  • Long-term sickness absence (Level of analysis: primary informal caregiver).

    Long-term sickness absence is analyzed as time-to-event from baseline on the week scale.

    Up to 10 years of follow-up.

  • Mental health (Level of analysis: primary informal caregiver).

    Mental health is analyzed as time-to-event from baseline on the week scale whichever comes first: redeemed psychotropic drug prescriptions, treatment for substance abuse or psychiatric hospital services.

    Up to 10 years of follow-up.

Secondary Outcomes (2)

  • Moderation of potential associations by psychosocial work environment (Level of analysis: primary informal caregiver)

    JEMs were composed of national survey data collected in 2000 and 2005.

  • Moderation of potential associations by occupational group (Level of analysis: primary informal caregiver).

    Annual data in the period between 2000 and 2018.

Study Arms (1)

Danish citizens

All citizens aged 0-25 years and all adults aged 18-67 years residing in Denmark in the period from 2000 to 2008.

Other: Primary informal caregiver at work.

Interventions

Employees becoming a primary informal caregiver for a child or an adolescent with mental health problems in the period from 2000 to 2018.

Danish citizens

Eligibility Criteria

Age0 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a nationalwide register-based study of occupational and mental health outcomes of all adult caregivers to children with and without mental health problems.

You may qualify if:

  • Children/adolescents: Citizens aged 0-25 years in the period between 2000 and 2018. Mental disorder is indicated by redeeming of psychotropic medication, treatment for substance abuse, and psychiatric services. Children of reference adult caregivers is defined by having no personal history of a mental disorder. We exclude children born outside of Denmark.
  • Adults: Citizens aged 18-67 years residing in Denmark, partaking in the work force in the period between 2000-2008, and living with a child in the household at any time until the child's 18th year or being a parent to a child at its birth.

You may not qualify if:

  • We exclude all citizens born in the Faroe Islands and in Greenland. We exclude all citizens residing in the Faroe Islands and in Greenland in the period between 2000 and 2018.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Team Working Life Denmark

Valby, 2500, Denmark

Location

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Johan H Jensen, PhD

    Team Working Life Denmark

    PRINCIPAL INVESTIGATOR
  • Johan H Jensen, PhD

    Occupational and Environmental Medicine, Copenhagen University Hospital - Bispebjerg & Frederiksberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2024

First Posted

June 4, 2024

Study Start

January 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

June 4, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Statistics Denmark's extensive collections of registers contain a significant potential for research and analysis. In order to use this research and analysis potential in accordance with the current register legislation and Statistics Denmark's data confidentiality principles, Statistics Denmark has established special micro-data schemes (Research Scheme, Authority Scheme and Legislative Model). Through the micro-data schemes, microdata (i.e. individual/single company data) is made available for specific research, investigation and analysis tasks for authorised research/analysis environments. Foreign research/analysis environments cannot be authorised for the scheme, but under certain conditions, foreign users can access data. Further information: https://www.dst.dk/en/TilSalg/Forskningsservice/Dataadgang

Locations