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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06218693 on ClinicalTrials.gov