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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
113
A family-based, multi-component, individual-tailored intervention based on case-management.
care as usual
Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark
Hellerup, Denmark
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
Time frame: Change from baseline to 4 years follow-up
Change in Children's Global Assessment Scale (CGAS)
A clinician rated measurment to asses general functioning in children (scale from 1-100. High score represent better outcome)
Time frame: Change from baseline to 4 years follow-up
Change in Family Assessment Device (FAD)
A 60 item parent report questionaire assesing family functioning ( scale 1-4. Low score represent better outcome) \[Time Frame: Change from baseline at 18 month follow-up\]
Time frame: Change from baseline to 4 years follow-up
Change in Home Observation for Measurement of the Environment (HOME)
A clinican rated semi structured interview measuring stimulation and support in the home ( scale 0-60. High score represent better outcome)
Time frame: Change from baseline to 4 years follow-up
Health-Related Quality of Life Questionnaire: KIDSCREEN -10
A child-rated questionnaire on Healthrelated Quality of Life., 5-point Likert Scale, score range 10-50 ( higher score better quality of life)
Time frame: Change from baseline to 4 years follow-up
This is Me (TIM)
A child-rated questionnaire on self-esteem,higher scores indicate better self-esteem
Time frame: Change from baseline to 4 years follow-up
Parental Stress Scale (PSS)
A parent-rated questionnaire on the quality of experienced stress related to parenting, score 1-5, higher score more perceived parental stress
Time frame: Change from baseline to 4 years follow-up
Personal and Social Performance Scale (PSP)
A clinician rated measurement to asses global functioning in parents, higher score indicates higher functioning
Time frame: Change from baseline to 4 years follow-up
Parenting Scale (PS)
A parent-rated questionnaire on parenting (30items) Higher scores indicate dysfunctional parenting
Time frame: Change from baseline to 4 years follow-up
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