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

NCT06218693 | Completed

• 1 other identifier: MHSCRDenmark_VIAFAMILY
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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. 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. 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

Keywords

Familial high-risk children; preventive psychiatry; offspring

Outcome Measures

Primary Outcomes (1)

• Change in "Strength and Difficulties Questionnaire" (SDQ)

  Parent reported 25-items questionaire of their child's behavioural and emotional difficulties, 3-point Likert scale (0,1,2), higher scores indicate more emotional or behavioral problems

  Change from baseline to 4 years follow-up

Secondary Outcomes (8)

• Change in Children's Global Assessment Scale (CGAS)

  Change from baseline to 4 years follow-up

• Change in Family Assessment Device (FAD)

  Change from baseline to 4 years follow-up

• Change in Home Observation for Measurement of the Environment (HOME)

  Change from baseline to 4 years follow-up

• Health-Related Quality of Life Questionnaire: KIDSCREEN -10

  Change from baseline to 4 years follow-up

• This is Me (TIM)

  Change from baseline to 4 years follow-up

Study Arms (2)

VIA Family intervention

EXPERIMENTAL

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.

Behavioral: VIA Family

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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.

Behavioral: Treatment As Usual (TAU)

Interventions

VIA Family BEHAVIORAL

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

VIA Family intervention

Treatment As Usual (TAU) BEHAVIORAL

care as usual

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• TrygFonden, Denmark: collaborator
• Child and Adolescent Mental Health Services, Research Unit, Capital Region, Denmark: collaborator

Study Sites (1)

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

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Therapeutics

Study Officials

• Anne A E Thorup

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 23, 2024
• Study Start: April 1, 2022
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

DK (1)