VIA Family 4 Year Follow-up of a Family-based Preventive Intervention
NCT06218693 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113
Last updated 2024-04-17
Summary
This study aims to investigate the long-term effects (2.5 years after post-intervention) of a preventive family-based intervention (VIA Family) compared with treatment as usual (TAU) for children of parents with a severe mental illness.
Background:
Children of parents with a mental illness have an increased lifetime risk of developing a mental illness themselves. Preventive interventions for families with children with high familial risk can potentially disrupt the transgenerational transmission.
The current study is a follow-up study of a trial investigating the effect of the preventive intervention: the VIA Family trial.
The VIA Family trial investigated the superiority of a preventive family-based intervention, VIA Family, compared with treatment as usual (TAU) in improving children's, parents' and families' functioning and well-being. Eligible families had at least one parent with a lifetime severe mental illness diagnosis ( i.e. recurrent major or moderate depression, bipolar disorder, or schizophrenia spectrum disorder), at least one child between the ages of 6-12 years and lived within the Frederiksberg or Copenhagen (Denmark). The trial had a randomized, two-armed, parallel and controlled design. The participating families were randomly assigned to both groups with an allocation ratio of 1:1.
The current study is a follow-up study aiming to explore the effect of the intervention 2.5 years after post-intervention.
The main research questions for the current follow-up study are:
1. Do children participating in the VIA Family intervention experience a greater decrease in symptoms of mental illness from baseline (timepoint 0) to long-term follow-up (timepoint 2) compared with children allocated to TAU?
2. Do parents participating in the VIA Family intervention experience a greater decrease in perceived parental stress from baseline (timepoint 0) to long-term follow-up (timepoint 2) compared with parents allocated to TAU?
Conditions
- Mental Disorder
Interventions
- BEHAVIORAL
-
VIA Family
A family-based, multi-component, individual-tailored intervention based on case-management.
- BEHAVIORAL
-
Treatment As Usual (TAU)
care as usual
Sponsors & Collaborators
-
TrygFonden, Denmark
collaborator INDUSTRY -
Child and Adolescent Mental Health Services, Research Unit, Capital Region, Denmark
collaborator UNKNOWN -
Mental Health Services in the Capital Region, Denmark
lead OTHER
Principal Investigators
-
Anne A E Thorup · Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-04-01
- Primary Completion
- 2024-01-30
- Completion
- 2024-01-30
Countries
- Denmark
Study Locations
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