NCT06218693

VIA Family 4 Year Follow-up of a Family-based Preventive Intervention

VIA Family - Family Based Early Intervention Versus Treatment as Usual- 4 Year Follow-up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
BEHAVIORAL	VIA Family	A family-based, multi-component, individual-tailored intervention based on case-management.
BEHAVIORAL	Treatment As Usual (TAU)	care as usual

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-01-30
• Completion: 2024-01-30
• First posted: 2024-01-23
• Last updated: 2024-04-17

Locations

1 site across 1 country: Denmark