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

April 15, 2024 updated by: Mental Health Services in the Capital Region, Denmark

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: VIA Family
A family-based, multi-component, individual-tailored intervention based on case-management.
Active Comparator: 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.
Behavioral: Treatment As Usual (TAU)
care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in "Strength and Difficulties Questionnaire" (SDQ)
Time Frame: Change from baseline to 4 years follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Children's Global Assessment Scale (CGAS)
Time Frame: Change from baseline to 4 years follow-up
A clinician rated measurment to asses general functioning in children (scale from 1-100. High score represent better outcome)
Change from baseline to 4 years follow-up
Change in Family Assessment Device (FAD)
Time Frame: Change from baseline to 4 years follow-up
A 60 item parent report questionaire assesing family functioning ( scale 1-4. Low score represent better outcome) [Time Frame: Change from baseline at 18 month follow-up]
Change from baseline to 4 years follow-up
Change in Home Observation for Measurement of the Environment (HOME)
Time Frame: Change from baseline to 4 years follow-up
A clinican rated semi structured interview measuring stimulation and support in the home ( scale 0-60. High score represent better outcome)
Change from baseline to 4 years follow-up
Health-Related Quality of Life Questionnaire: KIDSCREEN -10
Time Frame: Change from baseline to 4 years follow-up
A child-rated questionnaire on Healthrelated Quality of Life., 5-point Likert Scale, score range 10-50 ( higher score better quality of life)
Change from baseline to 4 years follow-up
This is Me (TIM)
Time Frame: Change from baseline to 4 years follow-up
A child-rated questionnaire on self-esteem,higher scores indicate better self-esteem
Change from baseline to 4 years follow-up
Parental Stress Scale (PSS)
Time Frame: Change from baseline to 4 years follow-up
A parent-rated questionnaire on the quality of experienced stress related to parenting, score 1-5, higher score more perceived parental stress
Change from baseline to 4 years follow-up
Personal and Social Performance Scale (PSP)
Time Frame: Change from baseline to 4 years follow-up
A clinician rated measurement to asses global functioning in parents, higher score indicates higher functioning
Change from baseline to 4 years follow-up
Parenting Scale (PS)
Time Frame: Change from baseline to 4 years follow-up
A parent-rated questionnaire on parenting (30items) Higher scores indicate dysfunctional parenting
Change from baseline to 4 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mental Health Services in the Capital Region, Denmark

Collaborators

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

Investigators

  • Principal Investigator: Anne A E Thorup, Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

January 30, 2024

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHSCRDenmark_VIAFAMILY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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