Clinical trial NCT06218693: VIA Family 4 Year Follow-up of a Family-based Preventive Intervention
Official title: VIA Family - Family Based Early Intervention Versus Treatment as Usual- 4 Year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder
Keywords: Familial high-risk children
preventive psychiatry
offspring
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
name: Child and Adolescent Mental Health Services, Research Unit, Capital Region, Denmark
First posted: 2024-01-23
Enrollment: 113
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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?


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.

Primary outcomes:
measure: Change in "Strength and Difficulties Questionnaire" (SDQ)
timeFrame: Change from baseline to 4 years follow-up
Secondary outcomes:
measure: Change in Children's Global Assessment Scale (CGAS)
timeFrame: Change from baseline to 4 years follow-up
measure: Change in Family Assessment Device (FAD)
timeFrame: Change from baseline to 4 years follow-up
measure: Change in Home Observation for Measurement of the Environment (HOME)
timeFrame: Change from baseline to 4 years follow-up
measure: Health-Related Quality of Life Questionnaire: KIDSCREEN -10
timeFrame: Change from baseline to 4 years follow-up
measure: This is Me (TIM)
timeFrame: Change from baseline to 4 years follow-up
measure: Parental Stress Scale (PSS)
timeFrame: Change from baseline to 4 years follow-up
measure: Personal and Social Performance Scale (PSP)
timeFrame: Change from baseline to 4 years follow-up
measure: Parenting Scale (PS)
timeFrame: Change from baseline to 4 years follow-up
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark
Study officials:
affiliation: Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark
name: Anne A E Thorup
role: PRINCIPAL_INVESTIGATOR
References: