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

NCT ID: NCT06218693

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-01-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

VIA Family intervention

VIA Family is a family based intervention. A multidisciplinary team of specialists from adult mental health services, child and adolescent mental health services and social services will be responsible for providing the basic treatment elements that are: case management and regular contact with the case manager, psychoeducation for the whole family, parental training (Triple P) and early intervention for mental problems of the child.

Group Type: EXPERIMENTAL

VIA Family

Intervention Type: BEHAVIORAL

A family-based, multi-component, individual-tailored intervention based on case-management.

Treatment as Usual (TAU)

TAU is defined as any kind of help and support focusing on high risk children and parental mental illness within the catchment area of the study. At present, the municipalities and the mental health services do not offer any kind of family focused intervention addressing parental mental illness that can be compared to the VIA Family program.

Group Type: ACTIVE_COMPARATOR

Treatment As Usual (TAU)

Intervention Type: BEHAVIORAL

care as usual

Interventions

VIA Family

A family-based, multi-component, individual-tailored intervention based on case-management.

Intervention Type: BEHAVIORAL

Treatment As Usual (TAU)

care as usual

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Child must have address registered in the municipality of Frederiksberg or Copenhagen.
• At least one of the biological parents must have a diagnosis of schizophrenia spectrum disorder, bipolar affective disorder or recurrent major depression.
• The parent with a diagnosis must have had at least one in- or outpatient contact with the mental health system within the lifetime of the child.

Exclusion Criteria

• Parents who do not speak and understand enough Danish to be able to give informed consent for their own and for the child's participation.
• If all family members are currently engaged in an intensive family intervention program addressing parental functioning and child development, they are excluded from the study.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TrygFonden, Denmark

INDUSTRY

Sponsor Role: collaborator

Child and Adolescent Mental Health Services, Research Unit, Capital Region, Denmark

UNKNOWN

Sponsor Role: collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne A E Thorup

Role: PRINCIPAL_INVESTIGATOR

Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark

Locations

Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark

Hellerup, , Denmark

Countries

Denmark

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MHSCRDenmark_VIAFAMILY

Identifier Type: -

Identifier Source: org_study_id