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Clinical Trial 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?


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT06218693
Study type Interventional
Source Mental Health Services in the Capital Region, Denmark
Contact
Status Completed
Phase N/A
Start date April 1, 2022
Completion date January 30, 2024

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